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Predilation of Side Branch During Percutaneous Treatment of Bifurcation Lesions With Provisional T Stenting

NCT01090856 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2014-12-05

No results posted yet for this study

Summary

Percutaneous treatment of bifurcation lesion is a complex procedure. After main vessel stent implantation, the side branch became jailed and the carina can be displaced resulting in complete occlusion of this vessel. Re-wiring the side branch in this conditions may result difficult and some times impossible. There is no agreement regarding the need of side branch pre-dilation (before main vessel stent implantation) to reduce these complications. Researchers from European Bifurcation Club have proposed no to pre-dilate the side branch to avoid vessel dissection and difficulties in rewiring the true lumen of the vessel. On the contrary, our group has a good experience in the treatment of bifurcation lesions treated with side branch pre-dilation.

Aims: 1.- To determine the efficacy of the side-branch pre-dilation in patients with bifurcations lesions treated with provisional T stenting. 2.- To determine the success rate and incidence of complications in patients with and without side-branch pre-dilation, as well as economic impact in terms of number of used wires.

Conditions

  • Coronary Angiography

Interventions

PROCEDURE

Pre-dilation side branch

Balloon pre-dilation of the side branch to facilitate the ulterior wire access.

Sponsors & Collaborators

  • Hospital Universitario Reina Sofia de Cordoba

    collaborator OTHER_GOV

  • Fundación Pública Andaluza Progreso y Salud

    lead OTHER

Principal Investigators

  • Manuel Pan Alvarez-Osorio, MD · Hospital Universitario Reina Sofia de Cordoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-11-30
Completion
2013-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01090856 on ClinicalTrials.gov