NCT00233805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2 coronary-artery-disease

Timeline
Completed

Started Aug 2000

Longer than P75 for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 6, 2008

Status Verified

August 1, 2008

First QC Date

October 4, 2005

Last Update Submit

August 5, 2008

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Angiographic in-stent late loss as determined by Quantitative Coronary Angiography.

    6 months follow-up

Secondary Outcomes (7)

  • In-stent mean %DS by QCA

    post-procedure

  • In-target vessel segment MLD

    6 months

  • In-stent MLD

    6 months

  • Target Lesion Revascularization

    6 and 12 months; or 2, 3, 4 and 5 years

  • Target Vessel Revascularization

    6 and 12 months; or 2, 3, 4 and 5 years

  • +2 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Bare metal Bx Velocity™ Balloon-Expandable Stent mounted on the Raptor® rapid exchange delivery system

Device: Bare metal Bx Velocity™

2

EXPERIMENTAL

Sirolimus coated modified Bx Velocity™ Balloon-Expandable Stent mounted on the Raptor® rapid exchange delivery system

Device: Sirolimus coated Bx Velocity™

Interventions

Sirolimus coated Bx Velocity™DEVICE

drug-eluting stent

2
Bare metal Bx Velocity™DEVICE

bare-metal stent

1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Marie-Claude Morice

Massy, F- 91300, France

Location

Related Publications (7)

  • 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.

    PMID: 17761505BACKGROUND

  • 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.

    PMID: 15723977RESULT

  • 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.

    PMID: 14720526RESULT

  • 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.

    PMID: 12370218RESULT

  • 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.

    PMID: 12176950RESULT

  • 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.

    PMID: 17903626RESULT

  • 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.

    PMID: 17296825DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Marie-Claude Morice, MD

    Institut Hospitalier Jacques Cartier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 6, 2005

Study Start

August 1, 2000

Study Completion

December 1, 2007

Last Updated

August 6, 2008

Record last verified: 2008-08

Locations

FR(1)