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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233805
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : August 6, 2008
Information provided by:
Cordis Corporation

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Sirolimus coated Bx Velocity™ Device: Bare metal Bx Velocity™ Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2000
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Bare metal Bx Velocity™ Balloon-Expandable Stent mounted on the Raptor® rapid exchange delivery system
Device: Bare metal Bx Velocity™
bare-metal stent
Experimental: 2
Sirolimus coated modified Bx Velocity™ Balloon-Expandable Stent mounted on the Raptor® rapid exchange delivery system
Device: Sirolimus coated Bx Velocity™
drug-eluting stent

Primary Outcome Measures :
  1. Angiographic in-stent late loss as determined by Quantitative Coronary Angiography. [ Time Frame: 6 months follow-up ]

Secondary Outcome Measures :
  1. In-stent mean %DS by QCA [ Time Frame: post-procedure ]
  2. In-target vessel segment MLD [ Time Frame: 6 months ]
  3. In-stent MLD [ Time Frame: 6 months ]
  4. Target Lesion Revascularization [ Time Frame: 6 and 12 months; or 2, 3, 4 and 5 years ]
  5. Target Vessel Revascularization [ Time Frame: 6 and 12 months; or 2, 3, 4 and 5 years ]
  6. Major Adverse Cardiac Events [ Time Frame: 30 days; 6 and 12 months; or 2, 3, 4 and 5 years; ]
  7. Neo-intimal growth assessed by IVUS [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00233805

Dr Marie-Claude Morice
Massy, France, F- 91300
Sponsors and Collaborators
Cordis Corporation
Principal Investigator: Marie-Claude Morice, MD Institut Hospitalier Jacques Cartier

Publications of Results:

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Hans-Peter Stoll - Director Clinical Affairs, Cordis Identifier: NCT00233805     History of Changes
Other Study ID Numbers: EC00-01
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: August 6, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs