Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions

NCT00232752 | Completed Phase 3 DMC

• 1 other identifier: P03-6319
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion late loss in patients with de novo native coronary artery lesions.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA.

  6 months post-procedure

Secondary Outcomes (10)

• Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced

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

• Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA.

  6 months post-procedure

• In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure.

  6 months post-procedure

• Target lesion revascularization (TLR) at 6 and 9 months post-procedure.

  6 and 9 months post-procedure

• Target vessel revascularization (TVR) at 6 and 9 months post-procedure.

  6 and 9 months post-procedure

Study Arms (1)

1

EXPERIMENTAL

Device: 4.0 CYPHER Sirolimus-Eluting Coronary Stent

Interventions

4.0 CYPHER Sirolimus-Eluting Coronary Stent DEVICE

4.0 CYPHER Sirolimus-Eluting Coronary Stent

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female patients minimum 18 years of age
• 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;
• Target lesions treatable with 4mm stent (visual estimate);
• Target lesion is 30mm 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, or is having a peri infarction;
• Documented Left ventricular ejection fraction 25%;
• Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

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

• Mauri Laura, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 5, 2005
• Study Start: September 1, 2003
• Primary Completion: January 1, 2005
• Study Completion: November 1, 2009
• Last Updated: December 2, 2009

Record last verified: 2009-12

Locations

US (1)