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

Not Applicable

Recruiting

• Conditions: Coronary Bifurcation Lesions
• Interventions: Device: a Paclitaxel Coated Balloon Catheter; Device: Sirolimus Coated Balloon Catheter

• Registration Number: NCT04899583
• Lead Sponsor: Acotec Scientific Co., Ltd

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 prospective, multicenter, randomized and open-label.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-24
• Study Start: 2021-11-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	a Paclitaxel Coated Balloon Catheter	a Paclitaxel Coated Balloon Catheter
Treatment Group	Sirolimus Coated Balloon Catheter	a Sirolimus Coated Balloon

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Diameter stenosis rate	9 months post procedure	Defined as the rate of restenosis (\>50% diameter stenosis) of main vessel after 9 months at 9 months post procedure.
Rate of procedure success	Immediately after procedure	Defined as the rate of achieving lesion success without MACE (composite of cardiac death, MI and TLR events) .
Rate of target lesion failure (TLF) or device-related composite endpoints (DoCE）	30 days, 6 months, 9 months, 12 months post procedure	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.
Rate of device success	Immediately after procedure	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.
Rate of lesion success	Immediately after procedure	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.
Late lumen loss (LLL)	9 months post procedure	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.
Angiographic binary restenosis (ABR) rate	9 months post procedure	Defined as the percentage rate of binary restenosis determined by angiographic at 9 months post procedure.
Rate of patient-related composite endpoints (PoCE）	30 days, 6 months, 9 months, 12 months post procedure	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.
Rate of composite safety endpoint	12 months post procedure	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.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China