Endeavor Zotarolimus - Eluting Stent in the Treatment Lesions in Small Native Coronary Arteries.

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Endeavor Zotarolimus-Eluting Coronary Stent

• Registration Number: NCT00609947
• Lead Sponsor: Medtronic Vascular

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-02-07
• Primary Completion: 2012-03
• Results First Submitted: 2013-06-05
• Study Completion: 2013-09
• Status Verified: 2015-01
• Results First Submitted QC: 2015-01-22
• Results First Posted: 2015-01-26
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endeavor Zotarolimus-Eluting Coronary Stent	Endeavor Zotarolimus-Eluting Coronary Stent	Zotarolimus-eluting stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE) Rate	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	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).

Trial Locations

Locations (1)

AnMed Health Medical Center; 🇺🇸 Anderson, South Carolina, United States