The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233805
• Other study ID #: EC00-01
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2005
• Last updated: August 5, 2008
• Start date: August 2000
• Est. completion date: December 2007

Study information

• Verified date: August 2008
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 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;

2. 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;

3. Target lesion is >= 2.5 and <= 3.5mm in diameter (visual estimate);

4. Target lesion is located in a native coronary artery which can be covered by one stent (single lesion);

5. Target lesion stenosis is >50% and <100% (TIMI I) (visual estimate).

Exclusion Criteria:

1. 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;

2. Unprotected left main coronary disease with >=50% stenosis;

3. Have an ostial target lesion;

4. Angiographic evidence of thrombus within target lesion;

5. Calcified lesions which cannot be successfully predilated;

6. Ejection fraction <=30%;

7. Totally occluded vessel (TIMI 0 level);

8. 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;

9. Planned Direct Stenting.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Sirolimus coated Bx Velocity™
drug-eluting stent
• Bare metal Bx Velocity™
bare-metal stent

Locations

Country	Name	City	State
France	Dr Marie-Claude Morice	Massy

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

France, 

References & Publications (6)

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 p — View 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, Wülfert E. Maintenance of — View 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. Epub 2007 Aug 29. — View 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. — View 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-Elutin — View 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 (RAndomize — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic in-stent late loss as determined by Quantitative Coronary Angiography.		6 months follow-up	Yes
Secondary	In-stent mean %DS by QCA		post-procedure	Yes
Secondary	In-target vessel segment MLD		6 months	Yes
Secondary	In-stent MLD		6 months	Yes
Secondary	Target Lesion Revascularization		6 and 12 months; or 2, 3, 4 and 5 years	Yes
Secondary	Target Vessel Revascularization		6 and 12 months; or 2, 3, 4 and 5 years	Yes
Secondary	Major Adverse Cardiac Events		30 days; 6 and 12 months; or 2, 3, 4 and 5 years;	Yes
Secondary	Neo-intimal growth assessed by IVUS		6 months	Yes