Jailed-balloon Technique in Coronary Bifurcation Lesion PCI (JBTinCBL)

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Procedure: Jailed-balloon technique; Procedure: Jailed-wire technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02167230

JBT

Details and patient eligibility

About

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).

Full description

1. Objective: To compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
2. Background: Solid evidence is scant to compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
3. Study design: This is a multi-center, prospective, randomized study.
4. 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.

Enrollment: 410 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years and ≤75 years;
2. De novo Medina 1,1,1 coronary bifurcation with a main branch(MB) >2.5mm while side branch <2.5mm and >1.5mm;
3. Only one bifurcation lesion need to be treated in one vessel;
4. 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%;
5. Signed consent is obtained.

Exclusion criteria

1. Left ventricular ejection fraction(LVEF) less than 30%;
2. Hemodynamic instability or cardiac shock;
3. Myopathy or muscular injury with elevation of creatine kinase to more than 3mg/dL;
4. Tumor with expected survival less than 1 year;
5. Autoimmune disease;
6. Active gastrointestinal bleeding or any contraindication for dual antiplatelet therapy;
7. Acute coronary syndrome require emergency PCI;
8. Coronary bifurcation need to be treated with two-stent strategy;
9. Not suitable for drug-eluting stent(DES) implantation;
10. Mental disorder or alcohol dependence;
11. PCI or coronary artery bypass graft (CABG) within 6 months before enrollment;
12. Target lesion is in-stent restenosis;
13. Women in gestation period or lactation period or human chorionic gonadotropin (HCG) urine test positive.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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410 participants in 2 patient groups

Jailed-balloon technique

Experimental group

Description:

Apply jailed-balloon technique to protect the side branch during coronary bifurcation PCI

Treatment:

Procedure: Jailed-balloon technique

Jailed-wire technique

Active Comparator group

Description:

Apply jailed-wire technique to protect the side branch during coronary bifurcation PCI

Treatment:

Procedure: Jailed-wire technique