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

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Stents, Angioplasty, Coronary Artery Disease, Bifurcation Coronary Lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Hospital Universitario Virgen MacarenaRecruiting
University Hospital Virgen Macarena

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Complex PCI strategy for bifurcation coronary lesions

Simple PCI strategies for bifurcation coronary lesions

Arm Description

Stenting main vessel and T-stenting for the side branch

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Combined rate of events (cardiac death, myocardial infarction and TLR)

Full Information

NCT ID

NCT00916695

First Posted

June 1, 2009

Last Updated

July 22, 2009

Sponsor

Spanish Society of Cardiology

1. Study Identification

Unique Protocol Identification Number

NCT00916695

Brief Title

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

Official Title

Everolimus-Eluting Stent in the Treatment of Bifurcation Lesions: Comparison of Main Vessel Stent to Main Vessel and Side Branch Stent

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

June 2009 (undefined)

Primary Completion Date

February 2011 (Anticipated)

Study Completion Date

February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Spanish Society of Cardiology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Stents, Angioplasty, Coronary Artery Disease, Bifurcation Coronary Lesions

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

332 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Complex PCI strategy for bifurcation coronary lesions

Arm Type

Active Comparator

Arm Description

Stenting main vessel and T-stenting for the side branch

Arm Title

Simple PCI strategies for bifurcation coronary lesions

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Combined rate of events (cardiac death, myocardial infarction and TLR)

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rafael J Ruiz-Salmeron, PhD

Phone

0034955693440

rjruizsalmeron@yahoo.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Federico Gimeno, MD

Organizational Affiliation

Hospital Clinico Universitario Valladolid

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bruno Garcia, MD

Organizational Affiliation

Hospital Valle de Hebron. Barcelona

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ramiro Trillo, MD

Organizational Affiliation

Hospital Clínico Santiago

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jose Moreu, MD

Organizational Affiliation

Hospital Virgen de la Salud

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Javier Goicolea, MD

Organizational Affiliation

Hospital Puerta de Hierro, Madrid

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Raul Moreno, MD

Organizational Affiliation

Hospital Universitario La Paz

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jose F Diaz, MD

Organizational Affiliation

Hospital Juan Ramon Jimenez. Huelva

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jose M Hernandez, MD

Organizational Affiliation

Hospital Clinico de Malaga

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ramon Lopez-Palop, MD

Organizational Affiliation

Hospital San Juan. Alicante

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mariano Valdes, MD

Organizational Affiliation

Hospital Universitario Virgen de la Arrixaca

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pascual Bordes, MD

Organizational Affiliation

Hospital Universitario. Alicante

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jose R Rumoroso, MD

Organizational Affiliation

Hospital Galdakao. Vizcaya

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario Virgen Macarena

City

Sevilla

ZIP/Postal Code

41007

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rafael J Ruiz-Salmeron, PhD

Phone

+34955693440

rjruizsalmeron@yahoo.es

Facility Name

University Hospital Virgen Macarena

City

Seville

ZIP/Postal Code

41007

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rafael j Ruiz-Salmeron, PhD

Phone

0034955693449

rjruizsalmeron@yahoo.es

First Name & Middle Initial & Last Name & Degree

Rafael J Ruiz-Salmeron, Phd

First Name & Middle Initial & Last Name & Degree

Manuel Vizcaino, PhD

First Name & Middle Initial & Last Name & Degree

Sergio Rodriguez-Leiras, MD

First Name & Middle Initial & Last Name & Degree

Cesar Carrascosa, MD

First Name & Middle Initial & Last Name & Degree

Francisco Marcos, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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