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

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).

Conditions

• Coronary Artery Disease

Interventions

DEVICE

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

Complex PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), and subsequent implanting of the stent in the main vessel, the side branch is approached by implanting a new stent as T technique. Simple PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), a stent is deployed at main vessel. Side branch is approached by using provisional T stenting technique.

Sponsors & Collaborators

• Spanish Society of Cardiology

  lead OTHER

Principal Investigators

• Federico Gimeno, MD · Hospital Clinico Universitario Valladolid

• Bruno Garcia, MD · Hospital Valle de Hebron. Barcelona

• Ramiro Trillo, MD · Hospital Clínico Santiago

• Jose Moreu, MD · Hospital Virgen de la Salud

• Javier Goicolea, MD · Hospital Puerta de Hierro, Madrid

• Raul Moreno, MD · Hospital Universitario La Paz

• Jose F Diaz, MD · Hospital Juan Ramon Jimenez. Huelva

• Jose M Hernandez, MD · Hospital Clinico de Malaga

• Ramon Lopez-Palop, MD · Hospital San Juan. Alicante

• Mariano Valdes, MD · Hospital Universitario Virgen de la Arrixaca

• Pascual Bordes, MD · Hospital Universitario. Alicante

• Jose R Rumoroso, MD · Hospital Galdakao. Vizcaya

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2011-02-28

Completion

2011-02-28

Countries

• Spain

Study Locations