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

Spanish Society of Cardiology

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.

Study type: Interventional

Funder types: Other

Identifiers

NCT00916695

XV02RS

Details and patient eligibility

About

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).

Enrollment: 332 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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332 participants in 2 patient groups

Complex PCI strategy for bifurcation coronary lesions

Active Comparator group

Description:

Stenting main vessel and T-stenting for the side branch

Treatment:

Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.

Simple PCI strategies for bifurcation coronary lesions

Active Comparator group

Description:

Stenting main vessel, with provisional stenting for the side branch.

Treatment:

Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.