The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions.

NCT00381420 | Completed Phase 3 DMC

• 1 other identifier: P01-6307
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY™ balloon-expandable stent. Both stents are mounted on the Raptor® Stent Delivery Systems. The secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different time points (8 months, 1 year, 3 and 5 years).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• in-stent minimum lumen diameter (MLD)

  8 months

Secondary Outcomes (7)

• composite of Major Adverse Cardiac Events defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization

  30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years

• angiographic binary restenosis (³50% diameter stenosis)

  8 months

• in-lesion MLD

  8 months

• target lesion revascularization

  9 months

• target vessel revascularization

  9 months

Study Arms (2)

1

EXPERIMENTAL

sirolimus-coated Bx Velocity stent

Device: drug-eluting stent

2

ACTIVE COMPARATOR

uncoated Bx Velocity stent

Device: bare-metal stent

Interventions

drug-eluting stent DEVICE

sirolimus-coated Bx VELOCITY Balloon-Expandable Stent

1

bare-metal stent DEVICE

un-coated Bx VELOCITY Stent

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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) OR patients with documented silent ischemia;
• Single treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
• Target vessel diameter at the lesion site is \>=2.50mm and \<=3.0mm in diameter (visual estimate);
• Target lesion is \>=15mm and \<=32mm in length (visual estimate);
• Target lesion stenosis is \>50% and \<100% (visual estimate);

You may not qualify if:

• Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
• Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction;
• Unprotected left main coronary disease with \>=50% stenosis;
• Significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
• Have an ostial target lesion;
• Angiographic evidence of thrombus within target lesion;
• Heavily calcified lesion which cannot be successfully predilated;
• Documented left ventricular ejection fraction \<=25%.

Sponsors & Collaborators

• Cordis US Corp.: lead

Related Publications (3)

• Schampaert E, Cohen EA, Schluter M, Reeves F, Traboulsi M, Title LM, Kuntz RE, Popma JJ; C-SIRIUS Investigators. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J Am Coll Cardiol. 2004 Mar 17;43(6):1110-5. doi: 10.1016/j.jacc.2004.01.024.

  PMID: 15028375 RESULT

• Rinfret S, Cohen DJ, Tahami Monfared AA, Lelorier J, Mireault J, Schampaert E. Cost effectiveness of the sirolimus-eluting stent in high-risk patients in Canada: an analysis from the C-SIRIUS trial. Am J Cardiovasc Drugs. 2006;6(3):159-68. doi: 10.2165/00129784-200606030-00003.

  PMID: 16780389 RESULT

• 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: 17296825 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Erick Schampaert, MD

  Hopital Sacreé-Coeur, Montréal, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 27, 2006
• Study Start: March 1, 2001
• Primary Completion: December 1, 2002
• Study Completion: June 1, 2008
• Last Updated: October 31, 2008

Record last verified: 2008-10