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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.

• 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

Arm && Interventions

Group	Intervention	Description
Complex PCI strategy for bifurcation coronary lesions	Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.	Stenting main vessel and T-stenting for the side branch
Simple PCI strategies for bifurcation coronary lesions	Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.	Stenting main vessel, with provisional stenting for the side branch.

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)

University Hospital Virgen Macarena; 🇪🇸 Seville, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain