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

Cordis US Corp.100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Coronary Artery Disease

Interventions

4.0 CYPHER Sirolimus-Eluting Coronary StentDEVICE

4.0 CYPHER Sirolimus-Eluting Coronary Stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or non-pregnant female patients minimum 18 years of age 2. 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; 3. Target lesions treatable with 4mm stent (visual estimate); 4. Target lesion is 30mm in length (visual estimate); 5. Target lesion stenosis is \>50% and \<100% (visual estimate); Exclusion Criteria: 1. 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; 2. Has unstable angina classified as Braunwald III B or C, or is having a peri infarction; 3. Documented Left ventricular ejection fraction 25%; 4. Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;

Locations (1)

Brigham & Women's Hospital

Boston, Massachusetts, United States

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

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

Time frame: 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.

Time frame: 6 months post-procedure

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

Time frame: 6 months post-procedure

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

Time frame: 6 and 9 months post-procedure

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

Time frame: 6 and 9 months post-procedure

Target vessel failure (TVF) at 6 and 9 months post-procedure.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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