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

A Prospective, Multicenter, Random Controlled Clinical Trail to Evaluate the Effectiveness and Safety of Sirolimus Coated Balloon Versus a Paclitaxel Coated Balloon in the Treatment of Coronary Bifurcation Lesion

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Bifurcation Lesions
• Intervention / Treatment: Device: Sirolimus Coated Balloon Catheter; Device: a Paclitaxel Coated Balloon Catheter

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lu Hao; Phone Number: 021-64041990; Email: lu.hao.@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Ge Junbo, MD; Phone Number: 021-64041990; Email: Ge.junbo@zs_hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; a Sirolimus Coated Balloon	Device: Sirolimus Coated Balloon Catheter; a Sirolimus Coated Balloon Catheter designed and produced by Acotec
Active Comparator: Control Group; a Paclitaxel Coated Balloon Catheter	Device: a Paclitaxel Coated Balloon Catheter; a Paclitaxel Coated Balloon Catheter(trade name:Bingo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure.	Defined as (1-minimum lumen diameter of target lesion/reference vessel diameter)*100% at 9 months post procedure.	9 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of device success	Defined as the rate of successful delivery and withdrawal of the delivery catheter, and achieving a final in-lesion residual stenosis less than 30% and TIMI flow grade 3 by using the assigned device only.	Immediately after procedure
Rate of lesion success	Defined as the rate of achieving a final in-lesion residual stenosis < 30% by visual estimate and TIMI flow grade 3 by using any percutaneous method.	Immediately after procedure
Rate of procedure success	Defined as the rate of achieving lesion success without MACE (composite of cardiac death, MI and TLR events) .	Immediately after procedure
Rate of target lesion failure (TLF) or device-related composite endpoints (DoCE）	Defined as a composite rate of cardiac death, target vessel-related MI, or ischemia-driven TLR events at 30 days, 6 months, 9 months and 12 months post procedure.	30 days, 6 months, 9 months, 12 months post procedure
Rate of patient-related composite endpoints (PoCE）	Defined as a composite rate of all cause death, all cause-related MI or TLR events at 30 days, 6 months, 9 months and 12 months post procedure.	30 days, 6 months, 9 months, 12 months post procedure
Diameter stenosis rate	Defined as the rate of restenosis (>50% diameter stenosis) of main vessel after 9 months at 9 months post procedure.	9 months post procedure
Late lumen loss (LLL)	Defined as the difference of minimum lumen diameter (MLD) from post procedure to 9 months follow-up, including late lumen loss of main vessel and side branch.	9 months post procedure
Angiographic binary restenosis (ABR) rate	Defined as the percentage rate of binary restenosis determined by angiographic at 9 months post procedure.	9 months post procedure
Rate of composite safety endpoint	Defined as a composite rate of all-cause death, cardiogenic death, myocardial infarction, target vessel-related myocardial infarction, incidence of thrombotic events (acute, subacute, late) defined by ARC at 12 months post procedure.	12 months post procedure

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd
• Collaborators: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Ge Junbo, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Paclitaxel; Sirolimus
• Other Study ID Numbers: ACOART SCB BIF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No