The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions.

NCT00235144 | Completed Phase 3 DMC

• 1 other identifier: EC00-07
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 2

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® Rapid Exchange Stent Delivery System.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• In-stent minimum lumen diameter (MLD).

  8 months.

Secondary Outcomes (7)

• Composite of MACE defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat TLR.

  1, 6, 9, and 12 months; 2, 3, 4, 5, 6, 7 and 8 years post procedure.

• Angiographic binary restenosis (>=50% diameter stenosis).

  8 months.

• In-lesion MLD.

  8 months.

• Target lesion revascularization.

  9 months.

• Target vessel revascularization.

  9 months.

Study Arms (2)

1

EXPERIMENTAL

drug-eluting stent

Device: sirolimus-coated Bx Velocity stent

2

ACTIVE COMPARATOR

bare-metal stent

Device: uncoated Bx Velocity stent

Interventions

sirolimus-coated Bx Velocity stent DEVICE

drug-eluting stent

1

uncoated Bx Velocity stent DEVICE

bare-metal 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;
• Treatment of a single de novo native coronary artery 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 and/or calcified lesion which cannot be successfully predilated;
• Documented left ventricular ejection fraction \<=25%;

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (2)

Herzkatheterlabor und Praxisklinik

Hamburg, Germany

Location

Med. Klinik und Poliklinik

Münster, Germany

Location

Related Publications (5)

• 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: 17761505 BACKGROUND

• Schampaert E, Moses JW, Schofer J, Schluter M, Gershlick AH, Cohen EA, Palisaitis DA, Breithardt G, Donohoe DJ, Wang H, Popma JJ, Kuntz RE, Leon MB; SIRIUS, E- and C-SIRIUS Investigators. Sirolimus-eluting stents at two years: a pooled analysis of SIRIUS, E-SIRIUS, and C-SIRIUS with emphasis on late revascularizations and stent thromboses. Am J Cardiol. 2006 Jul 1;98(1):36-41. doi: 10.1016/j.amjcard.2006.01.049. Epub 2006 May 4.

  PMID: 16784917 RESULT

• Schluter M, Schofer J, Gershlick AH, Schampaert E, Wijns W, Breithardt G; E- and C-SIRIUS Investigators. Direct stenting of native de novo coronary artery lesions with the sirolimus-eluting stent: a post hoc subanalysis of the pooled E- and C-SIRIUS trials. J Am Coll Cardiol. 2005 Jan 4;45(1):10-3. doi: 10.1016/j.jacc.2004.09.046.

  PMID: 15629365 RESULT

• Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G; E-SIRIUS Investigators. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet. 2003 Oct 4;362(9390):1093-9. doi: 10.1016/S0140-6736(03)14462-5.

  PMID: 14550694 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

Condition Hierarchy (Ancestors)

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

Study Officials

• Joachim Schofer, MD

  Herzkatheterlabor und Praxisklinik, Hamburg

  PRINCIPAL INVESTIGATOR

• Günter Breithardt, MD

  Med. Klinik und Poliklinik, Münster

  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: October 4, 2005
• First Posted: October 10, 2005
• Study Start: March 1, 2001
• Primary Completion: October 1, 2002
• Study Completion: September 1, 2008
• Last Updated: May 11, 2009

Record last verified: 2009-05

Locations

DE (2)