A Clinical Evaluation of the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Medtronic Vascular
- Enrollment
- 241
- Locations
- 1
- Primary Endpoint
- Major Adverse Cardiac Events (MACE) Rate
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The objective of this study is to verify the safety and efficacy of the Endeavor Zotarolimus-Eluting Coronary Stent System for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length ≤27 mm in native coronary arteries with reference vessels ≥ 2.25 mm to ≤ 2.75 mm.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Major Adverse Cardiac Events (MACE) Rate
Time Frame: 12 months post-procedure
Major Adverse Cardiac Events rate at 12 months post-procedure defined as death, target-vessel Myocardial Infarction (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization, repeat percutaneous transluminal coronary angioplasty or cardiac bypass surgery.
In-segment Percent Diameter Stenosis at 8 Months Post-procedure
Time Frame: 8 months post-procedure
In-segment percent diameter stenosis at 8 months post-procedure with percent diameter stenosis defined as the value calculated as 100 x (RVD - Minimal Lumen Diameter (MLD)/RVD using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiography (QCA).