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

NCT ID: NCT00916695

Last Updated: 2009-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-02-28

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).

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Complex PCI strategy for bifurcation coronary lesions

Stenting main vessel and T-stenting for the side branch

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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.

Simple PCI strategies for bifurcation coronary lesions

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Society of Cardiology

OTHER

Sponsor Role: lead

Responsible Party

Spanish Society of Cardiology

Principal Investigators

Federico Gimeno, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico Universitario Valladolid

Bruno Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Valle de Hebron. Barcelona

Ramiro Trillo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Santiago

Jose Moreu, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Salud

Javier Goicolea, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Puerta de Hierro, Madrid

Raul Moreno, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Jose F Diaz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Juan Ramon Jimenez. Huelva

Jose M Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico de Malaga

Ramon Lopez-Palop, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Juan. Alicante

Mariano Valdes, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen de la Arrixaca

Pascual Bordes, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario. Alicante

Jose R Rumoroso, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Galdakao. Vizcaya

Locations

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Site Status: RECRUITING

University Hospital Virgen Macarena

Seville, Seville, Spain

Site Status: NOT_YET_RECRUITING

Countries

Spain

Central Contacts

Rafael J Ruiz-Salmeron, PhD

Role: CONTACT

rjruizsalmeron@yahoo.es

0034955693440

Facility Contacts

Rafael J Ruiz-Salmeron, PhD

Role: primary

rjruizsalmeron@yahoo.es

+34955693440

Rafael j Ruiz-Salmeron, PhD

Role: primary

rjruizsalmeron@yahoo.es

0034955693449

Other Identifiers

XV02RS

Identifier Type: -

Identifier Source: secondary_id

XV02RS

Identifier Type: -

Identifier Source: org_study_id