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

Phase 4

Completed

• Conditions: Coronary Angiography
• Interventions: Procedure: Pre-dilation side branch

• Registration Number: NCT01090856
• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

Brief 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.

Detailed Description

Introduction: 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.

Design: Prospective and randomized study. Patients and methods: The series is constituted by 420 patients with bifurcations lesions that will be treated with drug-eluting stents; 210 patients will be treated with side branch pre-dilation before main vessels stent implantation, while the remaining 210 patients will be randomized to no pre-dilation of the side-branch.

Primary end point:

* TIMI flow at Side Branch after main vessel stent implantation.

Secondary end points:

* Time of re-wiring.

* Number of used wires.

* % of stenosis at Side Branch.

* Levels of CK and TpI after the procedure.

* Related cardiac events at 9 months. Relevance: Currently there has been controversy over the use of the side branch pre-dilation in patients with bifurcations lesions treated with provisional T-stenting. However, we have no comparative study in the literature.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-23
• Primary Completion: 2012-11
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• Patients with atherosclerotic coronary disease and bifurcation lesions an significant stenosis of the side branch.
• Main vessels diameter greater than 2.5 mm in diameter at the operator's visual estimate.
• The side branch should exceed 2.25 mm in diameter at the operator's visual estimate.
• Patients with damage to the main branch of any length and the side branch lesions smaller than 5 mm in length.
• Patients with bifurcation lesions fulfilling the following morphologies of the classification of Medina: 1 1 1, 1 0 1, 0 1 1.
• Treatment of bifurcation lesions with previsional drug eluting stents.
• Symptoms of stable angina or acute coronary syndrome.

Exclusion Criteria

• Contraindication to drug eluting stent implantation.
• Cardiogenic shock.
• Coexistence of other serious systemic diseases.
• Patients in whom it is impossible to guide placement in the side branch before stent implantation in the main vessel.
• Patients with bifurcation lesions and side branch less than 2 mm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Pre-dilation side branch	Pre-dilation side branch	-

Primary Outcome Measures

Name	Time	Method
Side branch coronary flow after main vessels stent implantation	Immediately after catheterization procedure

Secondary Outcome Measures

Name	Time	Method
Levels of markers of myocardial injury (CK and TpI) after the procedure	Immediately after catheterization procedure
Related cardiac events at 9 months	Immediately after catheterization procedure
Time required for rewiring of the side branch	Inmediately after catheterization procedure
Number of used wires	Inmediately after catheterization procedure

Trial Locations

Locations (1)

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain