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

Official title

A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of the Sirolimus-coated Spiral Balloon Catheter for the Treatment of Coronary Bifurcation Lesions

Overview

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.

Interventions

• Combination product Sirolimus coated balloon angioplasty
  This study involves the use of a Sirolimus-Coated Balloon (SCB) for the treatment of coronary artery disease, specifically targeting coronary bifurcation lesions. The SCB is coated with sirolimus, an antiproliferative drug that helps to prevent restenosis by inhibiting smooth muscle cell proliferation. The balloon is inflated at the target lesion site, delivering the drug directly to the arterial wall. This intervention aims to achieve vessel dilation while reducing the risk of restenosis, provi
• Combination product Paclitaxel coated balloon angioplasty
  This study involves the use of a Paclitaxel-Coated Balloon (PCB) for the treatment of coronary artery disease, specifically targeting coronary bifurcation lesions. The PCB is coated with paclitaxel, an antiproliferative drug that helps to prevent restenosis by inhibiting smooth muscle cell proliferation. The balloon is inflated at the target lesion site, delivering the drug directly to the arterial wall. This intervention aims to achieve vessel dilation while reducing the risk of restenosis, pro

Primary outcome measures

• Diameter stenosis (%) [Time frame: 6 months (±30 days)]

Secondary outcome measures (11)

• Interventional success rate [Time frame: Immediate post procedure (device and lesion success), and up to 7 days post-procedure (clinical success)]
• Quantitative Flow Ratio (QFR) [Time frame: 9 months (±30 days)]
• Rate of restenosis [Time frame: 9 months (±30 days)]
• Late lumen loss (LLL) [Time frame: 9 months (±30 days)]
• Target lesion revascularization (TLR) [Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days)]
• Target vessel revascularization (TVR) [Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days)]
• Target lesion failure (TLF) rate [Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days)]
• Thrombotic event rate [Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days)]
• Major adverse cardiac events (MACE) rate [Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days)]
• Adverse events (AEs) and serious adverse events (SAEs) rate [Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days)]
• Device defect rate [Time frame: Immediate post procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Peking University First Hospital — Beijing

Identifiers

NCT: NCT06618248 · SCB-CTP-B-V1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗