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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00233805
First received: October 4, 2005
Last updated: August 5, 2008
Last verified: August 2008
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Device: Sirolimus coated Bx Velocity™
Device: Bare metal Bx Velocity™
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cordis Corporation:

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

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

Enrollment: 220
Study Start Date: August 2000
Study Completion Date: December 2007
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233805

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Hans-Peter Stoll - Director Clinical Affairs, Cordis
ClinicalTrials.gov Identifier: NCT00233805     History of Changes
Other Study ID Numbers: EC00-01
Study First Received: October 4, 2005
Last Updated: August 5, 2008
Health Authority: France: Institutional Ethical Committee

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

ClinicalTrials.gov processed this record on May 23, 2013