Clinical trial NCT04899583: ACOART SCB BIF: Treatment of Coronary Bifurcation Lesion by Sirolimus Coated Balloon vs Paclitaxel Coated Balloon
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Bifurcation Lesions
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Zhongshan Hospital
First posted: 2021-05-24
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure.
timeFrame: 9 months post procedure
Secondary outcomes:
measure: Rate of device success
timeFrame: Immediately after procedure
measure: Rate of lesion success
timeFrame: Immediately after procedure
measure: Rate of procedure success
timeFrame: Immediately after procedure
measure: Rate of target lesion failure (TLF) or device-related composite endpoints (DoCE）
timeFrame: 30 days, 6 months, 9 months, 12 months post procedure
measure: Rate of patient-related composite endpoints (PoCE）
timeFrame: 30 days, 6 months, 9 months, 12 months post procedure
measure: Diameter stenosis rate
timeFrame: 9 months post procedure
measure: Late lumen loss (LLL)
timeFrame: 9 months post procedure
measure: Angiographic binary restenosis (ABR) rate
timeFrame: 9 months post procedure
measure: Rate of composite safety endpoint
timeFrame: 12 months post procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Ge Junbo
role: PRINCIPAL_INVESTIGATOR
References: