CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 420 enrolled
Drug / intervention
Pre-dilation side branchprocedure
Likely dose
Not stated in record
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Search/NCT01090856
NCT01090856Phase 4Completed

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

Fundación Pública Andaluza Progreso y Salud·interventional·Posted Mar 23, 2010·Updated Dec 5, 2014

In Brief

A Phase 4 clinical trial evaluating Pre-dilation side branch for Coronary Angiography. Completed, enrolled 420 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2010
Enrollment StartFeb 1, 2009
Primary CompletionNov 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.3 years ago

Interventions

Pre-dilation side branchprocedure

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