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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00916370
Registration number
NCT00916370
Ethics application status
Date submitted
5/06/2009
Date registered
9/06/2009
Date last updated
8/06/2015
Titles & IDs
Public title
SPIRIT PRIME Clinical Trial
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Scientific title
SPIRIT PRIME Clinical Trial.
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Secondary ID [1]
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06-373
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Universal Trial Number (UTN)
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Trial acronym
SPIRIT PRIME
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myocardial Ischemia
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Coronary Artery Stenosis
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0
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Coronary Disease
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0
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Coronary Artery Disease
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0
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Coronary Restenosis
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0
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Condition category
Condition code
Cardiovascular
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0
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Core size Xience Prime
Treatment: Devices - Xience Prime Long Lesion (LL)
Experimental: Core size registry (CSR) - Core size indicates the range of diameters of the stents used.
Experimental: Long lesion registry (LLR) - Use of long lesion stents.
Treatment: Devices: Core size Xience Prime
Core size includes a range of stent sizes.
Treatment: Devices: Xience Prime Long Lesion (LL)
Long lesion stent sizes include a range of sizes.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Target Lesion Failure (TLF)
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Assessment method [1]
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The composite rate of:
Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
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Timepoint [1]
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1 year
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Primary outcome [2]
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Target Lesion Failure (TLF)
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Assessment method [2]
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The composite rate of:
Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
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Timepoint [2]
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2 years
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Primary outcome [3]
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Target Lesion Failure (TLF)
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Assessment method [3]
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The composite rate of:
Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
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Timepoint [3]
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3 years
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Secondary outcome [1]
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Procedure Time
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Assessment method [1]
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Procedure time is defined as time between insertion and withdrawal of guide catheter.
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Timepoint [1]
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From insertion to withdrawal of guide catheter
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Secondary outcome [2]
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Device Success (Lesion Basis)
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Assessment method [2]
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Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).
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Timepoint [2]
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From the start of index procedure to end of index procedure
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Secondary outcome [3]
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Procedural Success (Subject Basis)
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Assessment method [3]
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Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.
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Timepoint [3]
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From the start of index procedure to end of index procedure
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Secondary outcome [4]
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All Death (Cardiac, Vascular, Non-cardiovascular)
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Assessment method [4]
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0
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Timepoint [4]
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In-hospital is less than or equal to 7 days post index procedure
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Secondary outcome [5]
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All Death (Cardiac, Vascular, Non-cardiovascular)
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Assessment method [5]
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0
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Timepoint [5]
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30 days
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Secondary outcome [6]
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0
All Death (Cardiac, Vascular, Non-cardiovascular)
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Assessment method [6]
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0
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Timepoint [6]
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180 days
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Secondary outcome [7]
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All Death (Cardiac, Vascular, Non-cardiovascular)
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Assessment method [7]
0
0
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Timepoint [7]
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1 year
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Secondary outcome [8]
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0
All Death (Cardiac, Vascular, Non-cardiovascular)
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Assessment method [8]
0
0
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Timepoint [8]
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0
2 years
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Secondary outcome [9]
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0
All Death (Cardiac, Vascular, Non-cardiovascular)
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Assessment method [9]
0
0
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Timepoint [9]
0
0
3 years
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Secondary outcome [10]
0
0
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
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Assessment method [10]
0
0
Per Protocol
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Timepoint [10]
0
0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.
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Secondary outcome [11]
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0
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
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Assessment method [11]
0
0
Per Protocol
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Timepoint [11]
0
0
30 days
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Secondary outcome [12]
0
0
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
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Assessment method [12]
0
0
Per Protocol
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Timepoint [12]
0
0
180 days
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Secondary outcome [13]
0
0
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
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Assessment method [13]
0
0
Per Protocol
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Timepoint [13]
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1 year
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Secondary outcome [14]
0
0
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
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Assessment method [14]
0
0
Per Protocol
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Timepoint [14]
0
0
2 years
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Secondary outcome [15]
0
0
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
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Assessment method [15]
0
0
Per Protocol
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Timepoint [15]
0
0
3 years
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Secondary outcome [16]
0
0
Non-target Vessel MI (Q-wave, Non Q-wave)
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Assessment method [16]
0
0
Per Protocol
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Timepoint [16]
0
0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
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Secondary outcome [17]
0
0
Non-target Vessel MI (Q-wave, Non Q-wave)
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Assessment method [17]
0
0
Per Protocol
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Timepoint [17]
0
0
30 days
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Secondary outcome [18]
0
0
Non-target Vessel MI (Q-wave, Non Q-wave)
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Assessment method [18]
0
0
Per Protocol
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Timepoint [18]
0
0
180 days
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Secondary outcome [19]
0
0
Non-target Vessel MI (Q-wave, Non Q-wave)
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Assessment method [19]
0
0
Per Protocol
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Timepoint [19]
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1 year
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Secondary outcome [20]
0
0
Non-target Vessel MI (Q-wave, Non Q-wave)
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Assessment method [20]
0
0
Per Protocol
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Timepoint [20]
0
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2 years
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Secondary outcome [21]
0
0
Non-target Vessel MI (Q-wave, Non Q-wave)
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Assessment method [21]
0
0
Per Protocol
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Timepoint [21]
0
0
3 years
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Secondary outcome [22]
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0
Clinically Indicated-Target Lesion Revascularization
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Assessment method [22]
0
0
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Timepoint [22]
0
0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
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Secondary outcome [23]
0
0
Clinically Indicated-Target Lesion Revascularization
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Assessment method [23]
0
0
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Timepoint [23]
0
0
30 days
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Secondary outcome [24]
0
0
Clinically Indicated-Target Lesion Revascularization
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Assessment method [24]
0
0
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Timepoint [24]
0
0
180 days
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Secondary outcome [25]
0
0
Clinically Indicated-Target Lesion Revascularization
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Assessment method [25]
0
0
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Timepoint [25]
0
0
1 year
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Secondary outcome [26]
0
0
Clinically Indicated-Target Lesion Revascularization
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Assessment method [26]
0
0
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Timepoint [26]
0
0
2 years
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Secondary outcome [27]
0
0
Clinically Indicated-Target Lesion Revascularization
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Assessment method [27]
0
0
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Timepoint [27]
0
0
3 years
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Secondary outcome [28]
0
0
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
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Assessment method [28]
0
0
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Timepoint [28]
0
0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
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Secondary outcome [29]
0
0
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
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Assessment method [29]
0
0
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Timepoint [29]
0
0
30 days
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Secondary outcome [30]
0
0
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
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Assessment method [30]
0
0
Query!
Timepoint [30]
0
0
180 days
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Secondary outcome [31]
0
0
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
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Assessment method [31]
0
0
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Timepoint [31]
0
0
1 year
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Secondary outcome [32]
0
0
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
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Assessment method [32]
0
0
Query!
Timepoint [32]
0
0
2 years
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Secondary outcome [33]
0
0
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
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Assessment method [33]
0
0
Query!
Timepoint [33]
0
0
3 years
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Secondary outcome [34]
0
0
All TLR (CI and Non-CI)
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Assessment method [34]
0
0
Query!
Timepoint [34]
0
0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
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Secondary outcome [35]
0
0
All TLR (CI and Non-CI)
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Assessment method [35]
0
0
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Timepoint [35]
0
0
30 days
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Secondary outcome [36]
0
0
All TLR (CI and Non-CI)
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Assessment method [36]
0
0
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Timepoint [36]
0
0
180 days
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Secondary outcome [37]
0
0
All TLR (CI and Non-CI)
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Assessment method [37]
0
0
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Timepoint [37]
0
0
1 year
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Secondary outcome [38]
0
0
All TLR (CI and Non-CI)
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Assessment method [38]
0
0
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Timepoint [38]
0
0
2 years
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Secondary outcome [39]
0
0
All TLR (CI and Non-CI)
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Assessment method [39]
0
0
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Timepoint [39]
0
0
3 years
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Secondary outcome [40]
0
0
All TVR (CI and Non-CI)
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Assessment method [40]
0
0
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Timepoint [40]
0
0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
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Secondary outcome [41]
0
0
All TVR (CI and Non-CI)
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Assessment method [41]
0
0
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Timepoint [41]
0
0
30 days
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Secondary outcome [42]
0
0
All TVR (CI and Non-CI)
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Assessment method [42]
0
0
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Timepoint [42]
0
0
180 days
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Secondary outcome [43]
0
0
All TVR (CI and Non-CI)
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Assessment method [43]
0
0
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Timepoint [43]
0
0
1 year
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Secondary outcome [44]
0
0
All TVR (CI and Non-CI)
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Assessment method [44]
0
0
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Timepoint [44]
0
0
2 years
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Secondary outcome [45]
0
0
All TVR (CI and Non-CI)
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Assessment method [45]
0
0
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Timepoint [45]
0
0
3 years
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Secondary outcome [46]
0
0
All Coronary Revascularization (TVR and Non-TVR)
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Assessment method [46]
0
0
Query!
Timepoint [46]
0
0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
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Secondary outcome [47]
0
0
All Coronary Revascularization (TVR and Non-TVR)
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Assessment method [47]
0
0
Query!
Timepoint [47]
0
0
30 days
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Secondary outcome [48]
0
0
All Coronary Revascularization (TVR and Non-TVR)
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Assessment method [48]
0
0
Query!
Timepoint [48]
0
0
180 days
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Secondary outcome [49]
0
0
All Coronary Revascularization (TVR and Non-TVR)
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Assessment method [49]
0
0
Query!
Timepoint [49]
0
0
1 year
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Secondary outcome [50]
0
0
All Coronary Revascularization (TVR and Non-TVR)
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Assessment method [50]
0
0
Query!
Timepoint [50]
0
0
2 years
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Secondary outcome [51]
0
0
All Coronary Revascularization (TVR and Non-TVR)
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Assessment method [51]
0
0
Query!
Timepoint [51]
0
0
3 years
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Secondary outcome [52]
0
0
Cardiac Death/All MI
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Assessment method [52]
0
0
Query!
Timepoint [52]
0
0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
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Secondary outcome [53]
0
0
Cardiac Death/ All MI
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Assessment method [53]
0
0
Per Protocol
Query!
Timepoint [53]
0
0
30 days
Query!
Secondary outcome [54]
0
0
Cardiac Death/All MI
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Assessment method [54]
0
0
Per Protocol
Query!
Timepoint [54]
0
0
180 days
Query!
Secondary outcome [55]
0
0
Cardiac Death/All MI
Query!
Assessment method [55]
0
0
Per Protocol
Query!
Timepoint [55]
0
0
1 year
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Secondary outcome [56]
0
0
Cardiac Death/All MI
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Assessment method [56]
0
0
Per Protocol
Query!
Timepoint [56]
0
0
2 years
Query!
Secondary outcome [57]
0
0
Cardiac Death/All MI
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Assessment method [57]
0
0
Per Protocol
Query!
Timepoint [57]
0
0
3 years
Query!
Secondary outcome [58]
0
0
Cardiac Death/ All MI/CI-TLR
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Assessment method [58]
0
0
Query!
Timepoint [58]
0
0
in-hospital
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Secondary outcome [59]
0
0
Cardiac Death/ All MI/CI-TLR
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Assessment method [59]
0
0
Per Protocol
Query!
Timepoint [59]
0
0
30 days
Query!
Secondary outcome [60]
0
0
Cardiac Death/ All MI/CI-TLR
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Assessment method [60]
0
0
Per Protocol
Query!
Timepoint [60]
0
0
180 days
Query!
Secondary outcome [61]
0
0
Cardiac Death/ All MI/CI-TLR
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Assessment method [61]
0
0
Per Protocol
Query!
Timepoint [61]
0
0
1 year
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Secondary outcome [62]
0
0
Cardiac Death/ All MI/CI-TLR
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Assessment method [62]
0
0
Per Protocol
Query!
Timepoint [62]
0
0
2 years
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Secondary outcome [63]
0
0
Cardiac Death/ All MI/CI-TLR
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Assessment method [63]
0
0
Per Protocol
Query!
Timepoint [63]
0
0
3 years
Query!
Secondary outcome [64]
0
0
All Death/All MI/All Coronary Revascularization
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Assessment method [64]
0
0
Per Protocol
Query!
Timepoint [64]
0
0
In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Query!
Secondary outcome [65]
0
0
All Death/All MI/All Coronary Revascularization
Query!
Assessment method [65]
0
0
Per Protocol
Query!
Timepoint [65]
0
0
30 days
Query!
Secondary outcome [66]
0
0
All Death/All MI/All Coronary Revascularization
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Assessment method [66]
0
0
Per Protocol
Query!
Timepoint [66]
0
0
180 days
Query!
Secondary outcome [67]
0
0
All Death/All MI/All Coronary Revascularization
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Assessment method [67]
0
0
Per Protocol
Query!
Timepoint [67]
0
0
1 year
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Secondary outcome [68]
0
0
All Death/All MI/All Coronary Revascularization
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Assessment method [68]
0
0
Per Protocol
Query!
Timepoint [68]
0
0
2 years
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Secondary outcome [69]
0
0
All Death/All MI/All Coronary Revascularization
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Assessment method [69]
0
0
Per Protocol
Query!
Timepoint [69]
0
0
3 years
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Secondary outcome [70]
0
0
Stent Thrombosis
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Assessment method [70]
0
0
Per protocol and per Academic Research Consortium (ARC, definite/probable)
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Timepoint [70]
0
0
Acute (=1 day)
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Secondary outcome [71]
0
0
Stent Thrombosis
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Assessment method [71]
0
0
Per protocol and per ARC
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Timepoint [71]
0
0
Subacute (>1 - 30 days)
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Secondary outcome [72]
0
0
Stent Thrombosis
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Assessment method [72]
0
0
Per protocol and per ARC
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Timepoint [72]
0
0
Acute/Subacute (0 - 30 days)
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Secondary outcome [73]
0
0
Stent Thrombosis
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Assessment method [73]
0
0
Per protocol and per ARC
Query!
Timepoint [73]
0
0
Late (31 - 393 days)
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Secondary outcome [74]
0
0
Stent Thrombosis
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Assessment method [74]
0
0
Per protocol
Query!
Timepoint [74]
0
0
Late (31 - 758 days)
Query!
Secondary outcome [75]
0
0
Stent Thrombosis
Query!
Assessment method [75]
0
0
Per ARC, definite and probable
Query!
Timepoint [75]
0
0
Very Late (394 - 758 days)
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Secondary outcome [76]
0
0
Stent Thrombosis
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Assessment method [76]
0
0
Per protocol
Query!
Timepoint [76]
0
0
Late (31 - 1123 days)
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Secondary outcome [77]
0
0
Stent Thrombosis
Query!
Assessment method [77]
0
0
Per ARC, definite and probable
Query!
Timepoint [77]
0
0
Very Late (394 - 1123 days)
Query!
Secondary outcome [78]
0
0
Stent Thrombosis
Query!
Assessment method [78]
0
0
Per protocol and per ARC
Query!
Timepoint [78]
0
0
Overall (0-393 days)
Query!
Secondary outcome [79]
0
0
Stent Thrombosis
Query!
Assessment method [79]
0
0
Per protocol
Query!
Timepoint [79]
0
0
Overall (0-758 days)
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Secondary outcome [80]
0
0
Stent Thrombosis
Query!
Assessment method [80]
0
0
Per ARC, definite and probable
Query!
Timepoint [80]
0
0
Overall (0-758 days)
Query!
Secondary outcome [81]
0
0
Stent Thrombosis
Query!
Assessment method [81]
0
0
Per protocol
Query!
Timepoint [81]
0
0
Overall (0 - 1123 days)
Query!
Secondary outcome [82]
0
0
Stent Thrombosis
Query!
Assessment method [82]
0
0
Per ARC, definite and probable
Query!
Timepoint [82]
0
0
Overall (0 - 1123 days)
Query!
Eligibility
Key inclusion criteria
1. Subject must be at least 18 years of age.
2. Subject or a legally authorized representative must provide written informed consent
prior to any study related procedure, per site requirements.
3. Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina,
silent ischemia, positive functional study or a reversible change in the
electrocardiogram (ECG) consistent with ischemia).
4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG)
surgery.
5. Subject must agree to undergo all protocol-required follow-up procedures.
6. Subject must agree not to participate in any other clinical study for a period of one
year following the index procedure.
Angiographic Inclusion Criteria
1. One or two de novo target lesions each in a different epicardial vessel.
2. If there are two target lesions, both lesions must satisfy the angiographic
eligibility criteria for that registry.
o Multiple focal de novo lesions in a target vessel that can be covered by a single
stent are allowed.
3. The target lesion(s) must be located in a major artery or branch with a visually
estimated diameter stenosis of = 50% and < 100% with a TIMI flow of = 1.
4. Target lesion(s) must be located in a native coronary artery with reference vessel
diameter (RVD) by visual estimation of:
- = 2.25 mm and = 4.25 mm for treatment by the core size XIENCE PRIME EECS
- = 2.5 mm and = 4.25 mm for treatment by the XIENCE PRIME LL EECS
5. Target lesion(s) must be located in a native coronary artery with length by visual
estimation of:
- = 22 mm for treatment by the core size XIENCE PRIME EECS
- > 22 mm and = 32 mm for treatment by the XIENCE PRIME LL EECS
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
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Query!
Sex
Both males and females
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Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the
index procedure (CK-MB = 2 times upper limit of normal) and CK and CK-MB have not
returned to within normal limits at the time of procedure.
2. The subject is currently experiencing clinical symptoms consistent with new onset AMI,
such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
3. Subject has current unstable cardiac arrhythmias associated with hemodynamic
instability.
4. Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be
obtained at the time of the index procedure if the value is unknown and if necessary).
5. Subject has received coronary brachytherapy in any epicardial vessel (target or non
target).
6. Subject has received any organ transplant or is on a waiting list for any organ
transplant.
7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30
days prior to or within one year after the index procedure.
8. Subject is receiving or scheduled to receive planned radiotherapy to the
chest/mediastinum.
9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or
autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus
etc.).
10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
11. Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
12. Subject has a known hypersensitivity or contraindication to aspirin,
heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel,
tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be
adequately pre-medicated.
13. Elective surgery is planned within 12 months after the procedure that will require
discontinuing either aspirin or clopidogrel.
14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood
cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including
laboratory evidence of hepatitis).
15. Subject has known renal insufficiency (examples being but not limited to estimated
glomerular filtration rate (eGFR) < 60 ml/kg/m2, serum creatinine level = 2.5 mg/dL,
or on dialysis).
16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood
transfusions.
17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological
attack (TIA) within the past six months.
18. Subject has had a significant gastro-intestinal or significant urinary bleed within
the past six months.
19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath
insertion.
20. Subject has other medical illness (e.g., cancer or congestive heart failure) or known
history of substance abuse (alcohol, cocaine, heroin etc.) that may cause
non-compliance with the protocol, confound the data interpretation or is associated
with a limited life expectancy (i.e., less than one year).
21. Subject is currently participating in another clinical study that has not yet
completed its primary endpoint.
22. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year
following index procedure. Female subjects of child-bearing potential must have a
negative pregnancy test done within 7 days prior to the index procedure per site
standard test.
Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual
estimation.
1. Target lesion located within an arterial or saphenous vein graft or distal to a
diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or
saphenous vein graft.
2. Target lesion involving a bifurcation with a side branch = 2 mm in diameter and/or
ostial lesion > 40% stenosed or side branch requiring protection guide wire, or side
branch requiring dilatation.
3. Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.
4. Another lesion requiring revascularization is located in the same epicardial vessel of
the target lesion.
5. Restenotic target lesion.
6. Aorto-ostial target lesion (within 3 mm of the aorta junction).
7. Target lesion is in a left main location.
8. Target lesion located within 2 mm of the origin of the LAD or LCX.
9. Extreme angulation (= 90 °) or excessive tortuosity (= two 45° angles) proximal to or
within the lesion.
10. Heavy calcification proximal to or within the target lesion.
11. Target vessel contains thrombus as indicated in the angiographic images.
12. Target lesion has a high probability that a procedure other than pre-dilatation and
stenting will be required at the time of index procedure for treatment of the target
vessel (e.g. atherectomy, cutting balloon).
13. Target vessel is previously treated with any type of PCI (e.g. balloon angioplasty,
stent, cutting balloon, atherectomy) < 9 months prior to index procedure.
14. Non-target vessel is previously treated with any type of PCI < 90 days prior to the
index procedure.
15. Additional clinically significant lesion(s) (e.g. %DS = 50%) in a target vessel or
side branch for which PCI may be required < 90 days after the index procedure.
Query!
Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2014
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Sample size
Target
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Accrual to date
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Final
525
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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0
Wesley Hospital - Auchenflower
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Recruitment hospital [2]
0
0
The Prince Charles Hospital - Chermside
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Recruitment hospital [3]
0
0
Monash Heart - Clayton
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Recruitment hospital [4]
0
0
St. Vincent's Hospital - Melbourne
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Recruitment hospital [5]
0
0
Epworth Hospital - Richmond
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Recruitment hospital [6]
0
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
0
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- Auchenflower
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Recruitment postcode(s) [2]
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4061 - Chermside
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3065 - Melbourne
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Recruitment postcode(s) [5]
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3121 - Richmond
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Recruitment postcode(s) [6]
0
0
- Perth
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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0
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Arizona
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0
0
United States of America
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California
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0
0
United States of America
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0
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District of Columbia
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Country [5]
0
0
United States of America
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0
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Florida
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0
0
United States of America
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0
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Illinois
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0
0
United States of America
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Indiana
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0
0
United States of America
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Iowa
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0
0
United States of America
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0
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Kansas
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0
0
United States of America
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State/province [10]
0
0
Louisiana
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Maryland
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Massachusetts
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Michigan
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Country [14]
0
0
United States of America
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State/province [14]
0
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Minnesota
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0
0
United States of America
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State/province [15]
0
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Missouri
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0
0
United States of America
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Montana
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0
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United States of America
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New Jersey
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New York
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0
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United States of America
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North Carolina
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0
0
United States of America
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Ohio
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0
0
United States of America
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0
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Oklahoma
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0
0
United States of America
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0
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Oregon
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0
0
United States of America
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0
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Pennsylvania
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0
0
United States of America
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0
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South Carolina
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United States of America
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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Vermont
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Virginia
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United States of America
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Washington
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Wisconsin
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion
(LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter
in subjects with symptomatic heart disease due to a maximum of two de novo native coronary
artery lesions, each in a different epicardial vessel.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00916370
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marco Costa, MD, PhD
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Address
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University Hospitals Cleveland Medical Center
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Phone
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Fax
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Email
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Contact person for public queries
Name
0
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00916370
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