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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/NCT01703000
Registration number
NCT01703000
Ethics application status
Date submitted
5/10/2012
Date registered
10/10/2012
Date last updated
15/04/2014
Titles & IDs
Public title
NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions
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Scientific title
NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of Atherosclerotic Lesion(s)
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Secondary ID [1]
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NG PROMUS Clinical Trial S2294
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis
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Coronary Artery Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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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 - Percutaneous coronary intervention (NG PROMUS)
Experimental: NG PROMUS stent - Single-arm treatment group receiving interventional NG PROMUS study stent
Treatment: Devices: Percutaneous coronary intervention (NG PROMUS)
Interventional coronary artery stenting with NG PROMUS study stent.
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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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Technical Success Rate
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Assessment method [1]
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Technical success is defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician
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Timepoint [1]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [1]
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Target Lesion Revascularization (TLR) Rate
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Assessment method [1]
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Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is >/= 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:
The subject has a positive functional study corresponding to the area served by the target lesion.
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.
The subject has ischemic symptoms referable to the target lesion. A TLR will be considered as ischemia-driven if the lesion diameter stenosis is >/= 70% by QCA even in the absence of clinical or functional ischemia.
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Timepoint [1]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
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Secondary outcome [2]
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Target Lesion Failure (TLF) Rate
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Assessment method [2]
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Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non-Q-wave) related to the target vessel, or (cardiac) death. For the purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the target vessel, it will be considered a TLF.
The MI definition used for Target Lesion Failure was the PLATINUM MI definition.
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Timepoint [2]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
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Secondary outcome [3]
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Target Vessel Revascularization (TVR) Rate
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Assessment method [3]
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Target vessel revascularization is defined as a TLR or a TVR remote. Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis >/= 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is >/= 50% by QCA and any of the following are present:
The subject has a positive functional study corresponding to the area served by the target vessel.
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.
The subject has ischemic symptoms referable to the target vessel. A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is >/=70% even in the absence of clinical or functional ischemia.
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Timepoint [3]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
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Secondary outcome [4]
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Target Vessel Failure (TVF) Rate
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Assessment method [4]
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Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
The MI definition used was the PLATINUM MI definition.
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Timepoint [4]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
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Secondary outcome [5]
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Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
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Assessment method [5]
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MI will be defined according to the PLATINUM Definition of MI with evidence pre-specified for i) Spontaneous, ii) PCI-related, iii) CABG related, and iv) autopsy evidence criteria.
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Timepoint [5]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
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Secondary outcome [6]
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Cardiac Death Rate
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Assessment method [6]
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Cardiac death is defined as death due to any of the following.
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
CVA through hospital discharge or CVA suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded
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Timepoint [6]
0
0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
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Secondary outcome [7]
0
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Non-cardiac Death Rate
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Assessment method [7]
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Non-cardiac death is defined as a death not due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
CVA through hospital discharge or CVA suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded
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Timepoint [7]
0
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Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
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Secondary outcome [8]
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All Death Rate
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Assessment method [8]
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Death is categorized as cardiac or non-cardiac deaths.
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Timepoint [8]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
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Secondary outcome [9]
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Cardiac Death or MI Rate
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Assessment method [9]
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Any cardiac death or MI event meeting the criteria defined for a cardiac death or MI.
MI definition used was the PLATINUM definition for MI.
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Timepoint [9]
0
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Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
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Secondary outcome [10]
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All Death or MI Rate
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Assessment method [10]
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Any all-cause mortality event or MI meeting the criteria defined for any death or MI.
MI definition used was the PLATINUM definition for MI.
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Timepoint [10]
0
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Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
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Secondary outcome [11]
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All Death/MI/TVR Rate
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Assessment method [11]
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Any event meeting the pre-specified criteria for any death, MI, or TVR.
MI definition used was the PLATINUM definition for MI.
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Timepoint [11]
0
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Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
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Secondary outcome [12]
0
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Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)
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Assessment method [12]
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Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guide catheter has been removed and the patient left the catheterization lab.
Timing:
Acute stent thrombosis*: 0 24 hours after stent implantation
Subacute stent thrombosis*: >24 hours to 30 days after stent implantation
Late stent thrombosis: >30 days to 1 year after stent implantation
Very late stent thrombosis: >1 year after stent implantation * Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0 30 days.
Stent thrombosis may be defined as:
Confirmed/definite
Probable
Possible
Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed)
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Timepoint [12]
0
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Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
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Secondary outcome [13]
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Clinical Procedural Success Rate
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Assessment method [13]
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Clinical procedural success is post-procedure diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.
MI definition used was the PLATINUM definition for MI.
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Timepoint [13]
0
0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [14]
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In-stent Percent Diameter Stenosis (%DS)
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Assessment method [14]
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As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-stent region.
Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.
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Timepoint [14]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [15]
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In-segment Percent Diameter Stenosis (%DS)
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Assessment method [15]
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As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-segment region (in-segment includes the stented region and 5 mm edge regions).
Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.
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Timepoint [15]
0
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [16]
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In-stent Minimum Lumen Diameter (MLD)
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Assessment method [16]
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As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-stent region.
The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.
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Timepoint [16]
0
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [17]
0
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In-segment Minimum Lumen Diameter (MLD)
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Assessment method [17]
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As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-segment region (in-segment includes the stented region and 5 mm edge regions).
The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.
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Timepoint [17]
0
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [18]
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Acute Gain
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Assessment method [18]
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Acute gain, as measured by angiographic core lab
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Timepoint [18]
0
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [19]
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Vessel Area
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Assessment method [19]
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As measured by IVUS, the mean vessel area (mm2).
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Timepoint [19]
0
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [20]
0
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Stent Area
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Assessment method [20]
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As measured by IVUS, the area of the stent.
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Timepoint [20]
0
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [21]
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Lumen Area
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Assessment method [21]
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As measured by IVUS, the area of the lumen.
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Timepoint [21]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [22]
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Vessel Volume
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Assessment method [22]
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As measured by IVUS, the volume of the vessel.
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Timepoint [22]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [23]
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Stent Volume
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Assessment method [23]
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As measured by IVUS, the volume of the stent.
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Timepoint [23]
0
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [24]
0
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Lumen Volume
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Assessment method [24]
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As measured by IVUS, the volume of the lumen.
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Timepoint [24]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [25]
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Incomplete Apposition
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Assessment method [25]
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Incomplete apposition rate, as measured by the IVUS core lab.
Binary assessment of presence of one or more stent struts separated from the vessel wall as detected through intravascular ultrasound (IVUS).
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Timepoint [25]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [26]
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Percent Net Volume Obstruction
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Assessment method [26]
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The percentage of volume obstruction, as measured by the IVUS core lab.
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Timepoint [26]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Secondary outcome [27]
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Longitudinal Stent Deformation
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Assessment method [27]
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Longitudinal stent deformation, evidenced by longitudinal compression or elongation, as the result of crossing a newly deployed stent with a second device, (such as a balloon catheter, stent system or IVUS catheter), causing the second device to become caught on the stent when the second device is advanced or retracted.
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Timepoint [27]
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Participants will be followed for the duration of hospital stay, an expected average of 1 day
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Eligibility
Key inclusion criteria
Clinical
1. Subject must be at least 18 years of age
2. Subject (or legal guardian) understands the trial requirements and the treatment
procedures and provides written informed consent before any trial-specific tests or
procedures are performed
3. Subject is eligible for percutaneous coronary intervention (PCI)
4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or
silent ischemia
5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
6. Subject is willing to comply with all protocol-required follow-up evaluation
Angiographic
1. Target lesion(s) must be located in a native coronary artery with a visually estimated
reference vessel diameter (RVD) =2.50 mm and =4.0 mm
2. Target lesion(s) length must be =34 mm (by visual estimate)
3. Target lesion(s) must have visually estimated stenosis =50% and <100% with
thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following
(stenosis =70%, abnormal fractional flow reserve (FFR), abnormal stress test or
imaging stress test, or elevated biomarkers) prior to procedure
4. Coronary anatomy is likely to allow delivery of a study device to the target
lesions(s)
5. The first lesion treated must be successfully pre-dilated/pretreated Note: Successful
pre-dilatation/pretreatment refers to dilatation with a balloon catheter of
appropriate length and diameter, or pretreatment with directional or rotational
coronary atherectomy, laser or cutting/scoring balloon with no greater than 50%
residual stenosis and no dissection greater than National Heart, Lung, Blood Institute
(NHLBI) type C.
Clinical
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with
acute ST elevation MI (STEMI)
2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or
mechanical circulatory support, intractable ventricular arrhythmias, or ongoing
intractable angina
3. Subject has received an organ transplant or is on a waiting list for an organ
transplant
4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or
after the index procedure
5. Planned PCI (including staged procedures) or CABG after the index procedure
6. Subject previously treated at any time with intravascular brachytherapy
7. Subject has a known allergy to contrast (that cannot be adequately premedicated)
and/or the trial stent system or protocol-required concomitant medications (e.g.,
platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related
compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
8. Subject has one of the following (as assessed prior to the index procedure):Other
serious medical illness (e.g., cancer, congestive heart failure) with estimated life
expectancy of less than 24 months; Current problems with substance abuse (e.g.,
alcohol, cocaine, heroin, etc.);Planned procedure that may cause non-compliance with
the protocol or confound data interpretation
9. Subject is receiving chronic (=72 hours) anticoagulation therapy (i.e., heparin,
coumadin) for indications other than acute coronary syndrome
10. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
11. Subject has a white blood cell (WBC) count < 3,000 cells/mm3
12. Subject has documented or suspected liver disease, including laboratory evidence of
hepatitis
13. Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
14. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood
transfusions
15. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic
attack (TIA) within the past 6 months
16. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
17. Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the
time of the index procedure
18. Subject is participating in another investigational drug or device clinical trial that
has not reached its primary endpoint
19. Subject intends to participate in another investigational drug or device clinical
trial within 12 months after the index procedure
20. Subject with known intention to procreate within 12 months after the index procedure
(women of child-bearing potential who are sexually active must agree to use a reliable
method of contraception from the time of screening through 12 months after the index
procedure)
21. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed
within 7 days prior to the index procedure in women of child-bearing potential)
Angiographic
1. Planned treatment of more than 3 lesions.
2. Planned treatment of lesions in more than 2 major epicardial vessels
3. Planned treatment of a single lesion with more than 1 stent
4. Subject has 2 target lesions in the same vessel that are separated by less than 15 mm
(by visual estimate)
5. Target lesion(s) is located in the left main
6. Target lesion(s) is located within 3 mm of the origin of the left anterior descending
(LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate.
7. Target lesion(s) is located within a saphenous vein graft or an arterial graft
8. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
9. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide
wire crossing
10. Target lesion(s) treated during the index procedure that involves a complex
bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
11. Target lesion(s) is restenotic from a previous stent implantation or study stent would
overlap with a previous stent
12. Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
13. Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent,
cutting balloon atherectomy) within 24 hours prior to the index procedure
14. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Single group
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Other design features
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Phase
Not Applicable
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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
1/11/2012
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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
1/03/2013
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Fremantle Hospital - Fremantle
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Recruitment postcode(s) [1]
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6160 - Fremantle
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Recruitment outside Australia
Country [1]
0
0
New Zealand
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State/province [1]
0
0
Auckland
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Country [2]
0
0
New Zealand
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State/province [2]
0
0
Christchurch
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Country [3]
0
0
New Zealand
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State/province [3]
0
0
Otahuhu
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Country [4]
0
0
Singapore
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State/province [4]
0
0
Singapore
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boston Scientific Corporation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting
Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of
Atherosclerotic Lesion(s)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01703000
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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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John A Ormiston, MBChB, FRACP, FRACR
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Address
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Mercy Angiography Unit, Ltd. Mercy Hospital
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01703000
Download to PDF