Study of the 2.25mm 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 restenosis in patients with de novo native coronary artery lesions.

This is a multicenter (approximately 10 - 14 sites), prospective, non-randomized study. The study is designed to evaluate the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in patients with de novo native coronary artery lesions. A total of 100 patients will be entered in the study. Patients who meet the eligibility criteria will be enrolled into the study. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4 and 5 years post-procedure, with all patients undergoing repeat angiography at 6 months. Approximately 50 patients will be required to have an intravascular ultrasound (IVUS) procedure at baseline and at the 6-month angiographic follow-up.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Coronary Artery Disease

Interventions

CYPHER Sirolimus-eluting Coronary StentDEVICE

2.25 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 lesion is 20mm in length (visual estimate); 4. 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)

Lenox Hill Hospital

New York, New York, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure

In-lesion restenosis was defined as over 50 percent diameter stenosis either within the stented segment or within 5 mm proximal or distal to the stent edges at a qualifying follow-up angiogram.

Time frame: From post-procedure to 6 months

Secondary Outcomes

Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up

The percentages are cumulative up to each of the scheduled post-procedure follow-up: 30 days, 6, 9, and 12 months, and 2, 3, 4 and 5 years. Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).

Time frame: From post-procedure to 4 years

Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.

In-stent restenosis was defined as greater than or equal 50 percent diameter stenosis within the stented segment at a qualifying follow-up angiogram.

Time frame: From post-procedure to 6 months

Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.

Time frame: From post-procedure to 6 months

Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.

TLR was defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel.

Time frame: From post-procedure to 6 months and 9 months

Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.

Data from ClinicalTrials.gov

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