Status:
UNKNOWN
ACOART SCB BIF: Treatment of Coronary Bifurcation Lesion by Sirolimus Coated Balloon vs Paclitaxel Coated Balloon
Lead Sponsor:
Acotec Scientific Co., Ltd
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Conditions:
Coronary Bifurcation Lesions
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT04899583
Start Date
November 10 2021
End Date
November 1 2025
Last Update
November 29 2023
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China