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

July 22, 2009 updated by: Spanish Society of Cardiology

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

332

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain, 41007
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
      • Seville, Spain, 41007
        • Not yet recruiting
        • University Hospital Virgen Macarena
        • Contact:
        • Principal Investigator:
          • Rafael J Ruiz-Salmeron, Phd
        • Sub-Investigator:
          • Manuel Vizcaino, PhD
        • Sub-Investigator:
          • Sergio Rodriguez-Leiras, MD
        • Sub-Investigator:
          • Cesar Carrascosa, MD
        • Sub-Investigator:
          • Francisco Marcos, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Complex PCI strategy for bifurcation coronary lesions
Stenting main vessel and T-stenting for the side branch
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.
ACTIVE_COMPARATOR: Simple PCI strategies for bifurcation coronary lesions
Stenting main vessel, with provisional stenting for the side branch.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Combined rate of events (cardiac death, myocardial infarction and TLR)
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Society of Cardiology

Investigators

  • Principal Investigator: Federico Gimeno, MD, Hospital Clínico Universitario Valladolid
  • Principal Investigator: Bruno Garcia, MD, Hospital Valle de Hebron. Barcelona
  • Principal Investigator: Ramiro Trillo, MD, Hospital Clínico Santiago
  • Principal Investigator: Jose Moreu, MD, Hospital Virgen De La Salud
  • Principal Investigator: Javier Goicolea, MD, Hospital Puerta de Hierro, Madrid
  • Principal Investigator: Raul Moreno, MD, Hospital Universitario La Paz
  • Principal Investigator: Jose F Diaz, MD, Hospital Juan Ramon Jimenez. Huelva
  • Principal Investigator: Jose M Hernandez, MD, Hospital Clínico de Malaga
  • Principal Investigator: Ramon Lopez-Palop, MD, Hospital San Juan. Alicante
  • Principal Investigator: Mariano Valdes, MD, Hospital Universitario Virgen de La Arrixaca
  • Principal Investigator: Pascual Bordes, MD, Hospital Universitario. Alicante
  • Principal Investigator: Jose R Rumoroso, MD, Hospital Galdakao. Vizcaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ANTICIPATED)

February 1, 2011

Study Completion (ANTICIPATED)

February 1, 2011

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (ESTIMATE)

June 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 23, 2009

Last Update Submitted That Met QC Criteria

July 22, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XV02RS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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