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

Launched by ACOTEC SCIENTIFIC CO., LTD · May 20, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different treatments for a specific heart condition called coronary bifurcation lesions, which occur where a coronary artery splits into two branches. The trial compares the use of a sirolimus-coated balloon to a paclitaxel-coated balloon to see which one better helps open up these narrow areas in the arteries.

To be eligible for this trial, participants must be between 18 and 75 years old and have certain heart conditions, such as stable or unstable chest pain or a history of heart attacks. They should be suitable for balloon treatment or stent placement. Participants will need to give their consent and may expect to undergo some tests related to their heart condition. It’s important to note that individuals with recent heart attacks, severe heart function issues, or certain other medical conditions are not eligible to participate. If you or someone you know is interested, this trial is currently recruiting participants, and further details can be obtained from the study team.

Gender

ALL

Eligibility criteria

• 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)