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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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
• Комбинированный продукт 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

Первичные конечные точки

• Diameter stenosis (%) [Срок оценки: 6 months (±30 days)]

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University First Hospital — Пекин

Идентификаторы

NCT: NCT06618248 · SCB-CTP-B-V1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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