Jailed-balloon Technique in Coronary Bifurcation Lesion PCI

Study Overview
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Brief Summary
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This study aims to test the hypothesis that jailed-balloon technique(JBT) is superior to jailed-wire technique(JWT) in non-left main coronary bifurcation percutaneous coronary intervention(PCI) by lowering the risk of side branch(SB) loss and PCI related myocardial infarction, as well as 1-year major adverse cardiovascular events(MACEs).

Detailed Description
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Objective: To compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions. Background: Solid evidence is scant to compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions. Study design: This is a multi-center, prospective, randomized study. Methods 4a. Study populations: Patients with non-left main coronary bifurcation lesions(Medina 1,1,1 ), which SBs are less than 2.5mm and more than 1mm, are enrolled in this study. Patients are randomized to JBT group and JWT group. 4b. Procedure: For patients enrolled in JBT group, a monorail balloon is placed at the ostium of SB to protect the SB before the stent in main branch(MB) is deployed. Only a PTCA wire would be placed in the SB while stenting MB for patients randomized in JWT group. Only drug-eluting stent should be implanted in the target vessel.

Official Title
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Effect of Jailed-Balloon Technique in Percutaneous Coronary Intervention for Non-Left Main Coronary Bifurcation Lesions: A Prospective, Randomized Study.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Jailed-balloon technique
* Procedure: Jailed-wire technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years and ≤75 years; De novo Medina 1,1,1 coronary bifurcation with a main branch(MB) >2.5mm while side branch <2.5mm and >1.5mm; Only one bifurcation lesion need to be treated in one vessel; The target lesion in MB has stenosis more than 75% or fractional flow reserve(FFR) less than 0.75 and the stenosis in SB ostium is more than 50%; Signed consent is obtained. Exclusion Criteria: Left ventricular ejection fraction(LVEF) less than 30%; Hemodynamic instability or cardiac shock; Myopathy or muscular injury with elevation of creatine kinase to more than 3mg/dL; Tumor with expected survival less than 1 year; Autoimmune disease; Active gastrointestinal bleeding or any contraindication for dual antiplatelet therapy; Acute coronary syndrome require emergency PCI; Coronary bifurcation need to be treated with two-stent strategy; Not suitable for drug-eluting stent(DES) implantation; Mental disorder or alcohol dependence; PCI or coronary artery bypass graft (CABG) within 6 months before enrollment; Target lesion is in-stent restenosis; Women in gestation period or lactation period or human chorionic gonadotropin (HCG) urine test positive.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jailed-balloon technique<br>Apply jailed-balloon technique to protect the side branch during coronary bifurcation PCI | Procedure: Jailed-balloon technique<br>* A monorail balloon is placed in the side branch(SB) before the stent in main branch(MB) is deployed. After MB stent is deployed to nominal pressure, the balloon in SB is inflated to 3 atm generally but to higher pressure to perform angioplasty if the blood flow in SB is compromised. The balloon in SB is then removed while the wire in SB is left in place. The MB stent balloon is inflated again for stent apposition. The SB wire is left in place to facilitate rewiring if the blood flow in SB is compromised. Otherwise the SB wire is removed after the stent balloon is inflated again.<br>|
| Active Comparator: Jailed-wire technique<br>Apply jailed-wire technique to protect the side branch during coronary bifurcation PCI | Procedure: Jailed-wire technique<br>* A percutaneous transluminal coronary angioplasty(PTCA) wire is placed in the side branch(SB) before the stent in main branch(MB) is deployed. After MB stent is deployed to some pressure to achieve full apposition, the wire in SB is left in place to facilitate rewiring if the blood flow in SB is compromised. Otherwise the SB wire is removed after the MB stent is deployed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side branch(SB) loss and PCI related myocardial infarction | The primary outcome of the study is a composite of SB loss or PCI related myocardial infarction. According to Thrombolysis in Myocardial Infarction (TIMI) flow grading system, SB loss is defined as less than TIMI 3 flow immediately following MB stenting. It is considered temporary SB loss if TIMI 3 flow is restored with angioplasty and/or stenting. Otherwise, SB loss is considered permanent. In patients with normal (≤99th percentile URL) baseline cardiac troponin(cTn) concentrations, PCI related myocardial infarction is defined as elevations of cTn >5× 99th percentile URL occurring within 48 hours of the procedure, which should be accompanied with other evidence of myocardial injury. A rise of >20% is required for the diagnosis of PCI related myocardial infarction if the baseline cTn values are elevated and are stable or falling. | Within 48 hours after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events(MACEs) | MACEs is a composite end point including cardiac death, non fatal myocardial infarction and target vessel revascularization(TVR). | Within 1 year after PCI | 
| PCI related complication | PCI related complication include coronary dissection, coronary perforation, device dislodgement, device entrapment and device rupture. | Immediately after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Percutaneous Coronary Intervention, Bifurcation, Jailed-balloon technique