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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/NCT00180310




Registration number
NCT00180310
Ethics application status
Date submitted
11/09/2005
Date registered
16/09/2005
Date last updated
20/07/2011

Titles & IDs
Public title
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Scientific title
A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Secondary ID [1] 0 0
03-364
Universal Trial Number (UTN)
Trial acronym
SPIRIT II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Disease 0 0
Coronary Artery Disease 0 0
Coronary Restenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - XIENCE V® Everolimus Eluting Coronary Stent
Treatment: Devices - TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Experimental: 1 - XIENCE V® Everolimus Eluting Coronary Stent System

Active Comparator: 2 - TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent


Treatment: Devices: XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.

Treatment: Devices: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
In-stent late loss (LL)
Timepoint [1] 0 0
at 180 days
Secondary outcome [1] 0 0
In-segment Late Loss
Timepoint [1] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [2] 0 0
In-stent Late Loss at 2 years (for a subset of 152 patients)
Timepoint [2] 0 0
at 2 years (for a subset of 152 patients)
Secondary outcome [3] 0 0
Proximal and distal Late Loss
Timepoint [3] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [4] 0 0
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate
Timepoint [4] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [5] 0 0
In-stent and in-segment percent Diameter Stenosis (% DS)
Timepoint [5] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [6] 0 0
In-stent percent Volume Obstruction (% VO)
Timepoint [6] 0 0
at 180 days and at 2 years for a subset of 152 patients
Secondary outcome [7] 0 0
Plaque behind the stent( by IVUS)
Timepoint [7] 0 0
at 180 days and at 2 years for a subset of 152 patients
Secondary outcome [8] 0 0
Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate
Timepoint [8] 0 0
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Secondary outcome [9] 0 0
Ischemia Driven Target Vessel Failure (ID-TVF)
Timepoint [9] 0 0
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Secondary outcome [10] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [10] 0 0
at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Secondary outcome [11] 0 0
Persisting incomplete stent apposition, late-acquired incomplete stent apposition
Timepoint [11] 0 0
at 180 days and at 2 years for a subset of 152 patients
Secondary outcome [12] 0 0
Aneurysm, thrombosis and persisting dissection
Timepoint [12] 0 0
at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Secondary outcome [13] 0 0
Acute success(device, procedure and clinical)
Timepoint [13] 0 0
Acute

Eligibility
Key inclusion criteria
- De novo Target lesion(s) must be located in a native epicardial vessel with diameter
between 2.25 mm and 4.25 mm by visual estimate

- The target lesion(s) must be in a major artery or branch with a visually estimated
stenosis of >= 50% and < 100% with a TIMI flow of >= 1

- Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if
done >= 90 days prior to the index procedure or if planned to be done > 9 months after
the index procedure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- De novo target lesion(s) located in a major epicardial vessel or a side branch that
has been previously treated with any type of percutaneous intervention (e.g., balloon
angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure

- Target lesion(s) restenotic from previous intervention

- Target lesion(s) located in a major epicardial vessel that has been previously treated
with brachytherapy

- Target vessel(s) contains visible thrombus

- Patient has a high probability that a procedure other than pre-dilatation, stenting
and post-dilatation will be required at the time of index procedure for treatment of
the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)

- Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a
target vessel or side branch for which an intervention within 9 months after the index
procedure may be required

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerpen
Country [3] 0 0
Belgium
State/province [3] 0 0
Liège
Country [4] 0 0
Denmark
State/province [4] 0 0
Aalborg
Country [5] 0 0
Denmark
State/province [5] 0 0
Aarhus
Country [6] 0 0
Denmark
State/province [6] 0 0
Copenhagen
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
France
State/province [8] 0 0
Rouen
Country [9] 0 0
France
State/province [9] 0 0
Toulouse
Country [10] 0 0
France
State/province [10] 0 0
Tours
Country [11] 0 0
Germany
State/province [11] 0 0
Bad Oeynhausen
Country [12] 0 0
Germany
State/province [12] 0 0
Bad Segeberg
Country [13] 0 0
Germany
State/province [13] 0 0
Dachau
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Germany
State/province [15] 0 0
Kassel
Country [16] 0 0
India
State/province [16] 0 0
New Delhi
Country [17] 0 0
Italy
State/province [17] 0 0
Reggio Emilia
Country [18] 0 0
Netherlands
State/province [18] 0 0
Amsterdam
Country [19] 0 0
Netherlands
State/province [19] 0 0
Breda
Country [20] 0 0
Netherlands
State/province [20] 0 0
Nieuwegein
Country [21] 0 0
Netherlands
State/province [21] 0 0
Rotterdam
Country [22] 0 0
Netherlands
State/province [22] 0 0
Zwolle
Country [23] 0 0
New Zealand
State/province [23] 0 0
Epsom
Country [24] 0 0
New Zealand
State/province [24] 0 0
Grafton
Country [25] 0 0
Poland
State/province [25] 0 0
Warsaw
Country [26] 0 0
South Africa
State/province [26] 0 0
Cape Town
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Switzerland
State/province [28] 0 0
Basel
Country [29] 0 0
Switzerland
State/province [29] 0 0
Geneva

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical
trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved
commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
System.

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston
Scientific.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00180310
Trial related presentations / publications
Garg S, Serruys P, Onuma Y, Dorange C, Veldhof S, Miquel-Hebert K, Sudhir K, Boland J, Huber K, Garcia E, te Riele JA; SPIRIT II Investigators. 3-year clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: the SPIRIT II trial (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2009 Dec;2(12):1190-8. doi: 10.1016/j.jcin.2009.10.002.
Public notes

Contacts
Principal investigator
Name 0 0
Patrick Serruys
Address 0 0
Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00180310