Everolimus-Eluting Stent for Bifurcation Coronary Lesions: Comparison of Simple Versus Complex Techniques

Phase 4

• Conditions: Coronary Artery Disease

• Registration Number: NCT00916695
• Lead Sponsor: Spanish Society of Cardiology

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of the treatment of true bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel and provisional T-stenting in the side branch) compared to the complex strategy (stent in main vessel and T-stenting in the side branch).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-09
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-22
• Last Update Posted: 2009-07-23
• Primary Completion: 2011-02
• Study Completion: 2011-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

• Patients over 18 years old.
• True Bifurcation lesion (Medina classification 1-1-1), in at least one main coronary vessel. Diameter of main vessel between 2,5-4mm, and diameter of side branch 2mm or greater.

Exclusion Criteria

• Significant left main stenosis.
• ST elevation myocardial infarction < 48 h.
• Thrombus burden target lesion.
• Ejection Fraction < 30%.
• Severe Renal Insufficiency (creatinine > 3 mg/dl).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of the rate of binary angiographic restenosis (in main vessel and side branch) in the simple versus complex strategy groups	9 months

Secondary Outcome Measures

Name	Time	Method
Combined rate of events (cardiac death, myocardial infarction and TLR)	8 months

Trial Locations

Locations (2)

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

University Hospital Virgen Macarena; 🇪🇸 Seville, Spain