A Multicenter, Non-Randomized Study of the 2.25mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Cordis Corporation
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure
- Status
- Completed
- Last Updated
- 16 years ago
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 restenosis in patients with de novo native coronary artery lesions.
Detailed Description
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.
Investigators
Eligibility Criteria
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 lesion is 20mm 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
Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure
Time Frame: From post-procedure to 6 months
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.
Secondary Outcomes
- Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up(From post-procedure to 4 years)
- Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.(From post-procedure to 6 months)
- Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.(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.(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.(From post-procedure to 6 months and 9 months follow-up)
- Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure(From post-procedure to 6 months and 9 months follow-up)
- Average Lumen Volume (mm3) at Post-procedure(At Post-procedure)
- Average Stent Obstruction Volume at Post-procedure(At post-procedure)
- Average Lumen Volume (mm3) at 6 Months Post-procedure(From post-procedure to 6 months)
- Average Stent Obstruction Volume at 6 Months Post-procedure(From post-procedure to 6 months)
- Percentage of Participants Who Achieved Lesion Success at Post-procedure(At post-procedure)
- Percentage of Participants Who Achieved Device Success at Post-procedure(At post-procedure)
- Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge(From post-procedure to hospital discharge)