NCT05093244撤回不适用
A Prospective, Randomized, Multi-center IDE Study to Assess the SeQuent Please ReX Drug Coated PTCA Balloon Catheter for the Treatment of In-stent Restenosis (RESPECT-ISR)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Freedom from target lesion failure (TLF)
研究概览
简要总结
The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated.
详细描述
The investigation is a prospective, randomized, multi-center IDE study comparing the SeQuent Please ReX to plain old balloon angioplasty (POBA). The study will be conducted at up to 30 investigational sites and enroll up to 296 patients with in-stent restenosis of a metallic coronary stent who are suitable candidates for PTCA procedures. After consent and assessment of inclusion and exclusion criteria, eligible patients will be randomized to either the SeQuent Please ReX or POBA arm based on a 2:1 randomization ratio. Subjects will return for follow-up through 5 years.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ISR (>50%) of a metallic coronary stent of any type (BMS or DES)
- •Symptomatic ischemic heart disease, including:
- •Chronic stable angina (and/or objective evidence of myocardial ischemia on functional study or fractional flow reserve [FFR] measurement) or
- •Acute coronary syndrome (unstable angina or non-ST-elevation myocardial infarction (NSTEMI)), who require elective or urgent percutaneous coronary intervention (PCI)
- •One or two ISR lesions requiring treatment
- •ISR lesions may be located in two different vessels
- •Additional non-ISR (de novo) lesions are permitted and may be located in the target or other vessels
- •Target lesion reference vessel diameter is ≥2.0 or ≤4.0 mm by visual estimation
- •Total lesion length less than or equal to 34 mm by visual estimation (to permit treatment with balloon up to 40 mm)
- •Male or female, age 18 years or older
- •Willing to provide written informed consent and written HIPAA authorization prior to initiation of study procedures
- •Willing to comply with the specified follow-up visits
- •Willing and able to comply with post-treatment medications (dual antiplatelet therapy (DAPT) followed by life-long aspirin)
- •Non-target lesions must be treated successfully (i.e., residual diameter stenosis <30% without complications) before proceeding to treatment of ISR lesion(s)
排除标准
- •Target lesion has undergone more than two prior stent implant procedures, i.e., more than two layers of stent are present at any segment of target lesion
- •Presents with ST-elevation myocardial infarction (STEMI)
- •STEMI within the past 72 hours
- •Chronic kidney disease, defined as glomerular filtration rate (GFR) <15 ml/min/1.73m^2 on baseline labs
- •Thrombocytopenia, defined as a platelet count of <50,000 microL on baseline labs
- •Target lesion is a chronic total occlusion
- •Bleeding diathesis, coagulopathy, or contraindication to antiplatelet therapy
- •Target lesion restenosis is within a bio-resorbable scaffold
- •Target lesion is located within the left main
- •Pregnant (verified with a urine or blood pregnancy test), breast-feeding, or planning to become pregnant
- •Severely disabled and/or life expectancy appears limited (≤12 months) according to the investigator's opinion
- •Known hypersensitivity to paclitaxel and/or resveratrol or any of the product ingredients
- •Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- •Note: Bifurcation lesions are not excluded; however, the main branch should be treated per randomization, and the side branch should be treated provisionally per current standard of care.
- •Angiographic Exclusion Criteria:
- •Subjects must not meet any of the following angiographic exclusion criteria after lesion preparation:
- •Dissection type C - F
- •TIMI < III
- •Residual stenosis >30%
研究组 & 干预措施
SeQuent Please ReX
Experimental
Drug coated balloon (DCB) catheter.
干预措施: SeQuent Please ReX (Device)
Plain old balloon angioplasty (POBA)
Active Comparator
干预措施: Plain old balloon angioplasty (POBA) (Device)
结局指标
主要结局
Freedom from target lesion failure (TLF)
时间窗: 12 months post-procedure
TLF is defined as the composite of any of the following events: * Clinically-driven target lesion revascularization (TLR) * Myocardial infarction (MI; not clearly attributable to a nontarget vessel) * Cardiovascular death
次要结局
- Late lumen loss (LLL)(9 months post-procedure)
- Myocardial infarction (MI)(12 months post-procedure and annually thereafter to study completion)
- All death(12 months post-procedure and annually thereafter to study completion)
- Device, lesion, and procedural success(Post-procedure (device and lesion success) and at discharge (procedural success))
- Cardiovascular death(12 months post-procedure and annually thereafter to study completion)
- Major adverse cardiac events (MACE)(12 months post-procedure and annually thereafter to study completion)
- Clinically-driven target lesion revascularization (TLR)(12 months post-procedure and annually thereafter to study completion)
- Stent thrombosis(12 months post-procedure and annually thereafter to study completion)
- Clinically-driven target vessel revascularization (TVR)(12 months post-procedure and annually thereafter to study completion)
研究者
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