NCT00916695

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
332

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

July 23, 2009

Status Verified

July 1, 2009

Enrollment Period

1.7 years

First QC Date

June 1, 2009

Last Update Submit

July 22, 2009

Conditions

Coronary Artery Disease

Keywords

StentsAngioplastyCoronary Artery DiseaseBifurcation Coronary Lesions

Outcome Measures

Primary Outcomes (1)

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

    9 months

Secondary Outcomes (1)

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

    8 months

Study Arms (2)

Complex PCI strategy for bifurcation coronary lesions

ACTIVE COMPARATOR

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.

Simple PCI strategies for bifurcation coronary lesions

ACTIVE COMPARATOR

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.

Interventions

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

Complex PCI strategy for bifurcation coronary lesionsSimple PCI strategies for bifurcation coronary lesions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Significant left main stenosis.
  • ST elevation myocardial infarction \< 48 h.
  • Thrombus burden target lesion.
  • Ejection Fraction \< 30%.
  • Severe Renal Insufficiency (creatinine \> 3 mg/dl).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Virgen Macarena

Seville, Sevilla, 41007, Spain

RECRUITING

University Hospital Virgen Macarena

Seville, Seville, 41007, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Federico Gimeno, MD

    Hospital Clinico 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 Clinico 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael J Ruiz-Salmeron, PhD

CONTACT

0034955693440rjruizsalmeron@yahoo.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 9, 2009

Study Start

June 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

July 23, 2009

Record last verified: 2009-07

Locations

ES(2)