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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Angiography

Intervention / Treatment
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* Procedure: Pre-dilation side branch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No pre-dilation side branch<br> | |
| Active Comparator: Pre-dilation side branch<br> | Procedure: Pre-dilation side branch<br>* Balloon pre-dilation of the side branch to facilitate the ulterior wire access.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side branch coronary flow after main vessels stent implantation |  | Immediately after catheterization procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for rewiring of the side branch |  | Inmediately after catheterization procedure | 
| Number of used wires |  | Inmediately after catheterization procedure | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bifurcations, Drug eluting-stents, Provisional stenting