Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)

Study Overview
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Brief Summary
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The role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous coronary intervention (PCI) is still not established. The predilatation could potentially damage SB ostium by vessel dissection, making subsequent wiring problematic. However, predilatation could eliminate SB ostial stenosis obviating need for further SB treatment after main vessel stent implantation. The aim of the study is to assess in random fashion the periprocedural myonecrosis, complication rates and time for SB rewiring in groups with and without SB predilatation.

Official Title
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Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)

Conditions
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Coronary Ostium Stenosis, Myonecrosis

Intervention / Treatment
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* Procedure: SB predilatation
* Procedure: No SB predilatation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject at least 18 years of age. Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm. Target lesion(s) amenable for PCI with balloon angioplasty of the side branch. Exclusion Criteria ST-segment elevation myocardial infarction (STEMI) Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment). Subjects who refuse to give informed consent. Subjects with left ventricle ejection fraction <30% Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy Contraindications for 12 months double antiplatelet therapy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB predilatation<br> | Procedure: SB predilatation<br>* Initial SB [predilatation.<br>Procedure: No SB predilatation<br>* Without SB predilatation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for rewiring SB |  | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periprocedural myonecrosis |  | 24 h | 
| MACE | death, MI, TVR | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periprocedural myonecrosis, procedure time, fluoroscopy time