A Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9TM Drug Coated Balloon for the Treatment of In-Stent Restenosis: First-in-Man Trial (REFORM)
试验速览
- 阶段
- 不适用
- 入组人数
- 201
- 试验地点
- 15
- 主要终点
- Percent Diameter Stenosis (DS)
研究概览
简要总结
The study is a Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis. It is a First-in-Man Trial.
详细描述
This clinical trial will serve as a first-in-human (FIH) experience for the BA9™ DCB in a population of patients with coronary artery disease who have an indication for interventional treatment of in-stent restenosis (ISR) in a bare-metal stent (BMS) or drug-eluting stent (DES).
The study uses a prospective, multi-center, single blind, randomized controlled trial design to enroll 195 patients. The study will seek to prove that the BA9-DCB is non-inferior to the approved CE marked Sequent Please® Paclitaxel Coated Balloon with respect to % Diameter Stenosis and has similar safety characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The subject will be blinded to the study treatment.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with in-stent restenosis (ISR) and clinical symptoms of ischemia and/or (i) evidence of ischemia on non-invasive testing or (ii) hemodynamically relevant lesion defined by FFR ≤ 0.80 or iFR ≤ 0.89 or > 90% stenosis.
- •Patient presenting with a lesion that can be fully covered with one DCB length. - Patients can have up to two index lesions with ISR, which can both be treated and evaluated.
- •Patient has provided written informed consent
- •Age ≥ 18 years.
- •Patient is willing and able to comply with the study procedures and follow-up.
排除标准
- •Patient presents with a ST-elevation myocardial infarction (STEMI) or had an acute MI within 48 hours prior to presentation (according to the universal definition of myocardial infarction).
- •Patient with acute cardiac decompensation or acute cardiogenic shock
- •Documented left ventricular ejection fraction (LVEF) ≤ 30%
- •Patient with impaired renal function (glomerular filtration rate < 80 mL/min/1.73 m2).
- •More than 2 epicardial vessels requiring revascularization
- •Significant left main stenosis (by visual estimation) or an ISR located in the left main (LM).
- •Patient has an ISR lesion that cannot be covered with one DCB length.
- •Patient has an ISR in the target segment in a stent of a smaller diameter than 2.5mm.
- •Severe calcification that might prevent a sufficient expansion of the DCB, if not pre-treated with rotablation or a shockwave application device.
- •Known hypersensitivity or contraindication to biolimus, paclitaxcel, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.
- •Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
- •Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.
- •Anticipated difficulties to complete the angiographic follow-up study.
- •Patient with a life expectancy of less than 12 months.
- •Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.
结局指标
主要结局
Percent Diameter Stenosis (DS)
时间窗: 6 months
Percent DS of the target segment assessed by quantitative coronary angiography (QCA)
次要结局
- Target lesion failure(1 month, 6 months, 1 year and 2 years)
- Target vessel failure(1 month, 6 months, 1 year and 2 years)