ACOART SCB BIF: Treatment of Coronary Bifurcation Lesion by Sirolimus Coated Balloon vs Paclitaxel Coated Balloon
NCT ID: NCT04899583
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
230 participants
INTERVENTIONAL
2021-11-10
2025-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group
a Sirolimus Coated Balloon
Sirolimus Coated Balloon Catheter
a Sirolimus Coated Balloon Catheter designed and produced by Acotec
Control Group
a Paclitaxel Coated Balloon Catheter
a Paclitaxel Coated Balloon Catheter
a Paclitaxel Coated Balloon Catheter(trade name:Bingo)
Interventions
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Sirolimus Coated Balloon Catheter
a Sirolimus Coated Balloon Catheter designed and produced by Acotec
a Paclitaxel Coated Balloon Catheter
a Paclitaxel Coated Balloon Catheter(trade name:Bingo)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
Exclusion Criteria
* 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.
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Acotec Scientific Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Ge Junbo
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ACOART SCB BIF
Identifier Type: -
Identifier Source: org_study_id