Comparing Sirolimus and Paclitaxel Coated Balloons for Treating Coronary Bifurcation Lesions

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

This study is testing whether a sirolimus coated balloon or a paclitaxel coated balloon works better for treating patients with specific heart artery problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Acotec Scientific Co., Ltd (industry)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04899583 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of sirolimus coated balloon catheters versus paclitaxel coated balloon catheters in treating coronary bifurcation lesions. It is a randomized, multicenter, and open-label trial designed to assess outcomes in patients diagnosed with stable or unstable angina, asymptomatic myocardial ischemia, or recent myocardial infarction. Participants will be monitored for their response to the different treatment approaches, focusing on safety and efficacy. The trial includes patients eligible for balloon dilatation or stent implantation.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with specific heart conditions eligible for balloon dilatation or stent implantation.

Not a fit: Patients who have had an acute myocardial infarction within the last 7 days or those with severe heart failure or arrhythmias may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with coronary bifurcation lesions.

How similar studies have performed: Other studies have explored similar treatment approaches, but the specific comparison of sirolimus versus paclitaxel coated balloons in this context is relatively novel.

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)

Where this trial is running

Shanghai, Shanghai

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Ge Junbo — Shanghai Zhongshan Hospital
• Study coordinator: Lu Hao

Conditions: Coronary Bifurcation Lesions