ACOART SCB BIF: Treatment of Coronary Bifurcation Lesion by Sirolimus Coated Balloon vs Paclitaxel Coated Balloon

Acotec Scientific

Status: Enrolling

Conditions: Coronary Bifurcation Lesions

Treatments: Device: a Paclitaxel Coated Balloon Catheter; Device: Sirolimus Coated Balloon Catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04899583

ACOART SCB BIF

Details and patient eligibility

About

The aim of this randomized controlled trial is to examine the treatment of coronary bifurcation lesion with a sirolimus coated balloon versus a paclitaxel coated balloon. This trial is designed as prospective, multicenter, randomized and open-label.

Enrollment: 230 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years old and ≤75 years old
• Diagnosed as stable or unstable angina pectoris, asymptomatic myocardial ischemia or old myocardial infarction, or recent myocardial infarction in stable stage.
• Eligible for balloon dilatation or stent implantation.
• Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed

Exclusion criteria

• AMI occurred within 7 days before operation
• The subjects had congestive heart failure or the heart function was classified as NYHA/KillipIV.
• Left ventricular ejection fraction (LVEF) < 35%
• History of heart transplantation
• The subjects had severe arrhythmias, such as high-risk ventricular extrasystole and / or ventricular tachycardia.
• The subjects had stroke, gastrointestinal bleeding or active ulcers, or had a high risk of bleeding in the past 6 months.
• Active bleeding physique or blood coagulation disorder
• Known renal insufficiency（eGFR<30ml/min）
• Contraindicated to anticoagulants or antiplatelet agents
• Has a history of percutaneous coronary intervention (PCI) within 6 months before enrollment.
• Has contraindications for coronary artery bypass grafting
• known to be allergic to aspirin, heparin, contrast agents, paclitaxel and sirolimus
• Life expectancy less than 12 months, or unable to complete a 12-month follow-up
• Pregnant or lactating females, or who plan to become pregnant during a follow-up period of 1 year after operation
• The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.

Angiographic Inclusion Criteria:

• One target lesion (bifurcation lesion) in the coronary artery is allowed, and if there are coexistent non-bifurcated lesions requiring PCI intervention, only one lesion was accepted at most, and the target lesion should be treated after successful PCI treatment of non-target lesion.
• Target Lesion located in native coronary artery must be de novo
• Medina classification should be (1.1.1, 1.0.1, 0.1.1)
• Main branch of target lesion (%DS is ≥70% or ≥50% with clinical symptoms ) is suitable for stent implantation
• Target Lesion located in main branch should be covered by DES. Moreover, the residual stenosis ≤ 30%, TIMI flow is 3, no complications and branch vessel opening stenosis ≥ 70%.
• Reference vessel diameter of the branch is 2.0-4.0mm (by visual)
• Target lesion length ≤ 36mm (by visual)

Angiographic Exclusion Criteria:

• Target or non-target lesion located in left main
• Subjects who have non-target lesions of bifurcation
• The target lesion is trifurcation or multifurcation lesion.
• Main branch of target lesion located within 3 mm from the ostium of LAD or LCx or RCA
• The branch lesion is a diffuse long lesion, which could't covered by one DCB.
• Main or side branch is occlusive lesion, which TIMI flow is 0.
• Aneurysm existed in the blood vessel at the target lesion
• Side branch severely calcified or tortuous
• The blood pressure was too low to tolerate intracoronary injection of ≥ 100ug nitroglycerin
• Failure pre-dilatation of the side branch ostium (residual stenosis > 30% ,the blood flow in TIMI is not up to grade 3, or has dissection of type C or above according to NHLBI grade)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Treatment Group

Experimental group

Description:

a Sirolimus Coated Balloon

Treatment:

Device: Sirolimus Coated Balloon Catheter

Control Group

Active Comparator group

Description:

a Paclitaxel Coated Balloon Catheter

Treatment:

Device: a Paclitaxel Coated Balloon Catheter