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Clinical Trials/NCT00232752
NCT00232752CompletedPhase 3

A Multicenter, Non-Randomized Study of the 4.0mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions

Cordis Corporation2 sites in 1 country100 target enrollmentStarted: September 2003Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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);

Exclusion Criteria

  • •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;

Outcomes

Primary Outcomes

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

Time Frame: 6 months post-procedure

Secondary Outcomes

  • Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA.(6 months post-procedure)
  • 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)
  • 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)
  • Target vessel failure (TVF) at 6 and 9 months post-procedure.(6 and 9 months post-procedure)
  • Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of approximately 50 patients at selected centers.(post-procedure and six months in a subset of approximately 50 patients)
  • Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.(End of study)
  • Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.(End of Study)
  • Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay.(during the hospital stay)

Investigators

Sponsor Class
Industry

Study Sites (2)

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