Back to resultsThe Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study. (RAVEL)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Sirolimus coated Bx Velocity™
Bare metal Bx Velocity™
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia; Single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent of 18mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment; Target lesion is >= 2.5 and <= 3.5mm in diameter (visual estimate); Target lesion is located in a native coronary artery which can be covered by one stent (single lesion); Target lesion stenosis is >50% and <100% (TIMI I) (visual estimate). Exclusion Criteria: A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal; Unprotected left main coronary disease with >=50% stenosis; Have an ostial target lesion; Angiographic evidence of thrombus within target lesion; Calcified lesions which cannot be successfully predilated; Ejection fraction <=30%; Totally occluded vessel (TIMI 0 level); Target lesion involves bifurcation including a side branch >=2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting which is likely to occur if side branch is diseased and intended to be stented; Planned Direct Stenting.
Sites / Locations
- Dr Marie-Claude Morice
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Bare metal Bx Velocity™ Balloon-Expandable Stent mounted on the Raptor® rapid exchange delivery system
Sirolimus coated modified Bx Velocity™ Balloon-Expandable Stent mounted on the Raptor® rapid exchange delivery system
Outcomes
Primary Outcome Measures
Angiographic in-stent late loss as determined by Quantitative Coronary Angiography.
Secondary Outcome Measures
In-stent mean %DS by QCA
In-target vessel segment MLD
In-stent MLD
Target Lesion Revascularization
Target Vessel Revascularization
Major Adverse Cardiac Events
Neo-intimal growth assessed by IVUS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233805
Brief Title
The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.
Acronym
RAVEL
Official Title
A Randomized Study With the Sirolimus Coated Modified BX Velocity Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of this study is to assess the safety and effectiveness of the sirolimus coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the bare metal Bx VELOCITY balloon-expandable stent. Both stents will be mounted on the Raptor Rapid Exchange Delivery Stent System.
Detailed Description
This is a multicenter (19 sites), prospective, randomized study. This study has a 2 arm design assessing the safety and effectiveness of the sirolimus coated BxTM VELOCITY stent to the bare metal BxTM VELOCITY stent, both mounted on the Raptorâ Rapid Exchange Stent Delivery System. A total of 220 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be randomized to the coated or uncoated BX VELOCITY stent. Therefore, neither the Investigator nor the patient will know which stent will be implanted. Patients will be followed for twelve months post-procedure, with all patients having a repeat angiography at 6 months. An ancillary study with in-stent IVUS measurements at 6 months follow-up will be performed in all patients of 6 pre-selected clinical sites. It is assumed that these sites will enroll more than 90 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Bare metal Bx Velocity™ Balloon-Expandable Stent mounted on the Raptor® rapid exchange delivery system
Arm Title
2
Arm Type
Experimental
Arm Description
Sirolimus coated modified Bx Velocity™ Balloon-Expandable Stent mounted on the Raptor® rapid exchange delivery system
Intervention Type
Device
Intervention Name(s)
Sirolimus coated Bx Velocity™
Intervention Description
drug-eluting stent
Intervention Type
Device
Intervention Name(s)
Bare metal Bx Velocity™
Intervention Description
bare-metal stent
Primary Outcome Measure Information:
Title
Angiographic in-stent late loss as determined by Quantitative Coronary Angiography.
Time Frame
6 months follow-up
Secondary Outcome Measure Information:
Title
In-stent mean %DS by QCA
Time Frame
post-procedure
Title
In-target vessel segment MLD
Time Frame
6 months
Title
In-stent MLD
Time Frame
6 months
Title
Target Lesion Revascularization
Time Frame
6 and 12 months; or 2, 3, 4 and 5 years
Title
Target Vessel Revascularization
Time Frame
6 and 12 months; or 2, 3, 4 and 5 years
Title
Major Adverse Cardiac Events
Time Frame
30 days; 6 and 12 months; or 2, 3, 4 and 5 years;
Title
Neo-intimal growth assessed by IVUS
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia;
Single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent of 18mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
Target lesion is >= 2.5 and <= 3.5mm in diameter (visual estimate);
Target lesion is located in a native coronary artery which can be covered by one stent (single lesion);
Target lesion stenosis is >50% and <100% (TIMI I) (visual estimate).
Exclusion Criteria:
A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
Unprotected left main coronary disease with >=50% stenosis;
Have an ostial target lesion;
Angiographic evidence of thrombus within target lesion;
Calcified lesions which cannot be successfully predilated;
Ejection fraction <=30%;
Totally occluded vessel (TIMI 0 level);
Target lesion involves bifurcation including a side branch >=2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting which is likely to occur if side branch is diseased and intended to be stented;
Planned Direct Stenting.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Claude Morice, MD
Organizational Affiliation
Institut Hospitalier Jacques Cartier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Marie-Claude Morice
City
Massy
ZIP/Postal Code
F- 91300
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17761505
Citation
Hoffmann R, Morice MC, Moses JW, Fitzgerald PJ, Mauri L, Breithardt G, Schofer J, Serruys PW, Stoll HP, Leon MB. Impact of late incomplete stent apposition after sirolimus-eluting stent implantation on 4-year clinical events: intravascular ultrasound analysis from the multicentre, randomised, RAVEL, E-SIRIUS and SIRIUS trials. Heart. 2008 Mar;94(3):322-8. doi: 10.1136/hrt.2007.120154. Epub 2007 Aug 29.
Results Reference
background
PubMed Identifier
15723977
Citation
Fajadet J, Morice MC, Bode C, Barragan P, Serruys PW, Wijns W, Constantini CR, Guermonprez JL, Eltchaninoff H, Blanchard D, Bartorelli A, Laarman GJ, Perin M, Sousa JE, Schuler G, Molnar F, Guagliumi G, Colombo A, Ban Hayashi E, Wulfert E. Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial. Circulation. 2005 Mar 1;111(8):1040-4. doi: 10.1161/01.CIR.0000156334.24955.B2. Epub 2005 Feb 21.
Results Reference
result
PubMed Identifier
14720526
Citation
Abizaid A, Costa MA, Blanchard D, Albertal M, Eltchaninoff H, Guagliumi G, Geert-Jan L, Abizaid AS, Sousa AG, Wuelfert E, Wietze L, Sousa JE, Serruys PW, Morice MC; Ravel Investigators. Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial. Eur Heart J. 2004 Jan;25(2):107-12. doi: 10.1016/j.ehj.2003.11.002.
Results Reference
result
PubMed Identifier
12370218
Citation
Regar E, Serruys PW, Bode C, Holubarsch C, Guermonprez JL, Wijns W, Bartorelli A, Constantini C, Degertekin M, Tanabe K, Disco C, Wuelfert E, Morice MC; RAVEL Study Group. Angiographic findings of the multicenter Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent (RAVEL): sirolimus-eluting stents inhibit restenosis irrespective of the vessel size. Circulation. 2002 Oct 8;106(15):1949-56. doi: 10.1161/01.cir.0000034045.36219.12.
Results Reference
result
PubMed Identifier
12176950
Citation
Serruys PW, Degertekin M, Tanabe K, Abizaid A, Sousa JE, Colombo A, Guagliumi G, Wijns W, Lindeboom WK, Ligthart J, de Feyter PJ, Morice MC; RAVEL Study Group. Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial. Circulation. 2002 Aug 13;106(7):798-803. doi: 10.1161/01.cir.0000025585.63486.59.
Results Reference
result
PubMed Identifier
17903626
Citation
Morice MC, Serruys PW, Barragan P, Bode C, Van Es GA, Stoll HP, Snead D, Mauri L, Cutlip DE, Sousa E. Long-term clinical outcomes with sirolimus-eluting coronary stents: five-year results of the RAVEL trial. J Am Coll Cardiol. 2007 Oct 2;50(14):1299-304. doi: 10.1016/j.jacc.2007.06.029. Epub 2007 Sep 17.
Results Reference
result
PubMed Identifier
17296825
Citation
Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007 Mar 8;356(10):989-97. doi: 10.1056/NEJMoa066633. Epub 2007 Feb 12.
Results Reference
derived
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The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.
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