Efficacy and Safety of Sirolimus-Coated Spiral Balloon for Coronary Bifurcation Lesions

Not Applicable

Recruiting

• Conditions: Coronary Bifurcation Lesion
• Interventions: Combination Product: Sirolimus coated balloon angioplasty; Combination Product: Paclitaxel coated balloon angioplasty

• Registration Number: NCT06618248
• Lead Sponsor: Dongguan TT Medical

Brief Summary

This is a multicenter, prospective randomized controlled study to evaluate the safety and effectiveness of Sirolimus-coated spiral balloon (SuperFlow®) versus Paclitaxel-coated balloon (Bingo™) in the treatment of coronary bifurcation lesions.

Detailed Description

This is a prospective, multicenter, randomized controlled, non-inferiority trial conducted across 13-20 sites. The study aims to enroll 280 patients with true coronary bifurcation lesions in native coronary arteries.

Eligible patients will be randomized in a 1:1 ratio to receive either the Sirolimus-coated spiral balloon (SuperFlow®) or the Paclitaxel-coated balloon (Bingo™), following a site-specific blocked randomization schedule.

All participants will be screened based on the trial's predefined inclusion and exclusion criteria. Data and imaging will be collected during the index procedure and at the predefined 9-month clinical follow-up visit.

Study Timeline

• Study Start: 2023-12-20
• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-28
• Study First Posted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-09
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Patients aged between 18 and 85 years, regardless of gender.
• Patients must voluntarily participate in the study and sign an informed consent form.
• Patients must demonstrate sufficient adherence to the study protocol and agree to follow-up visits at 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) post-procedure, with angiography required at 9 months (±30 days).
• Patients must have evidence of myocardial ischemia.
• Angiographically confirmed primary coronary bifurcation lesions (Medina classification non-0, 0, 1) with branch stenosis ≥70% (estimated visually).
• Patients suitable for PCI where the branch lesion is not expected to require stenting; stenting is planned for the main vessel, with DCB used on the branch. It is recommended to treat the branch with DCB first, followed by main vessel stenting.
• Residual stenosis ≤50% after pre-treatment of the branch lesion, TIMI 3 flow, with no dissection or only A or B grade dissection. C grade dissections should be carefully considered by the investigator before deciding, and are generally not included.
• The diameter of the branch vessel must be between 2.0 mm and 4.0 mm, with a lesion length ≤40 mm.

Exclusion Criteria

• Patients with bleeding disorders or active gastrointestinal ulcers, those who have had a stroke within the past 6 months, or those who are expected to be intolerant to dual antiplatelet therapy post-intervention.
• Patients with severe renal insufficiency (creatinine level > 3.0 mg/dL or 265.2 µmol/L) and/or end-stage renal disease requiring dialysis.
• Patients in cardiogenic shock.
• Patients who have experienced a myocardial infarction within the week prior to enrollment.
• Patients with severe congestive heart failure or NYHA class IV severe heart failure.
• Patients with severe valvular heart disease.
• Patients who have undergone heart transplantation.
• Patients with a life expectancy of less than 1 year.
• Patients currently participating in other drug or device clinical trials that have not yet reached the primary endpoint.
• Patients with contraindications to taking aspirin and/or clopidogrel and/or ticagrelor.
• Patients known to be allergic to paclitaxel, rapamycin, contrast agents, etc.
• Pregnant or breastfeeding women, those with plans to conceive within the year, or those unwilling to use effective contraception.
• Target vessels that are completely occluded, severely calcified, have >45° angulation, or are non-protected left main lesions.
• Non-target lesions that cannot be treated prior to or fail to be treated successfully before addressing the target lesion.
• Target lesions in branch vessels that are in-stent restenosis.
• Other patients deemed unsuitable for inclusion by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sirolimus-coated spiral balloon (SuperFlow®)	Sirolimus coated balloon angioplasty	A PTCA spiral balloon catheter with sirolimus coating (3ug/mm\^2) on balloon surface
Paclitaxel-coated balloon (Bingo™）	Paclitaxel coated balloon angioplasty	A PTCA balloon catheter with paclitaxel coating (3ug/mm\^2) on balloon surface

Primary Outcome Measures

Name	Time	Method
Diameter stenosis (%)	6 months (±30 days)	Percentage of target vessel stenosis per angiographic measurement at 6 months follow up

Secondary Outcome Measures

Name	Time	Method
Interventional success rate	Immediate post procedure (device and lesion success), and up to 7 days post-procedure (clinical success)	Including device success, lesion success, and clinical success; Device Success: Includes successful delivery of the device and successful treatment.; Successful Delivery: Successful delivery of the designated device to the lesion and release, with the delivery system retracting smoothly. Successful Treatment: Immediately post-procedure, residual stenosis of the target lesion is less than 50% with TIMI grade 3 flow (visual assessment).; Lesion Success: After any interventional treatment, residual stenosis of the target lesion is less than 50% with TIMI grade 3 flow (visual assessment).; Clinical Success: Based on lesion success, no major adverse cardiac events occurred during hospitalization (up to 7 days post-procedure).
Quantitative Flow Ratio (QFR)	9 months (±30 days)	In the presence of stenotic lesions in the coronary artery, the ratio of the maximum blood flow that the artery can deliver to the myocardial region to the maximum blood flow that could theoretically be obtained in that region under normal conditions.
Rate of restenosis	9 months (±30 days)	Coronary angiography results showing a diameter stenosis of ≥50% are considered indicative of restenosis.
Late lumen loss (LLL)	9 months (±30 days)	The difference between the minimum lumen diameter of the target lesion segment immediately post-procedure and the minimum lumen diameter of the same segment during the angiographic follow-up at 9 months post-procedure.
Target lesion revascularization (TLR)	1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days)	Including repeat PCI with stent implantation, balloon angioplasty, plaque atherectomy, or coronary artery bypass grafting (CABG)
Target vessel revascularization (TVR)	1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days)	Including repeat PCI with stent implantation, balloon angioplasty, plaque atherectomy, or CABG
Target lesion failure (TLF) rate	1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days)	Including cardiac death, target vessel-related myocardial infarction, and target lesion revascularization
Thrombotic event rate	1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days)	Rate of thrombosis
Major adverse cardiac events (MACE) rate	1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days)	Including all-cause death, all myocardial infarctions, and all repeat revascularizations
Adverse events (AEs) and serious adverse events (SAEs) rate	1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days)	Rate of AEs or SAEs
Device defect rate	Immediate post procedure	Rate of device defect