NCT01090856

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Fundación Pública Andaluza Progreso y Salud · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Angiography

Interventions

Type	Name	Description
PROCEDURE	Pre-dilation side branch	Balloon pre-dilation of the side branch to facilitate the ulterior wire access.

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-11-01
• Completion: 2013-05-01
• First posted: 2010-03-23
• Last updated: 2014-12-05

Locations

1 site across 1 country: Spain