SELUTION SLR™ 014 ISR: A Prospective Randomized Single Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Subjects With In-stent Restenosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 418
- 试验地点
- 95
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial.
Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR 014 DEB or SOC to include contemporary DES (zotarolimus-eluting stents [ZES] and everolimus-eluting stents [EES] only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA.
The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR 014 DEB in all patients.
详细描述
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial will enroll up to 418 randomized subjects (including up to 60 subjects in an angiographic and optical coherence tomography [OCT] sub-study) at up to 80 sites in the United States (US), Canada, Brazil, and Europe (EU). A minimum of 50% of the subjects will be enrolled in the US.
Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR 014 DEB or SOC to include contemporary DES (zotarolimus-eluting stents [ZES] and everolimus-eluting stents [EES] only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA.
The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR 014 DEB group.
A subset of up to 60 subjects will be enrolled in the angiographic and OCT sub-study and undergo planned angiographic and OCT follow-up within 30 days after completion of the 12-month primary endpoint clinical follow-up/assessment.
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)
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
- •Clinical Inclusion Criteria:
- •Subject age is ≥ 18 years or minimum legal age as required by local regulations.
- •Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure.
- •Subject presents with chronic coronary syndrome (CCS) (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST-elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for percutaneous coronary intervention (PCI) and planned intervention.
- •Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either Clopidogrel, Prasugrel, or Ticagrelor. Note: Subjects who require continued oral anticoagulant therapy my omit aspirin at discretion of investigator.
- •Life expectancy >1 year in opinion of investigator.
- •Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
- •Angiographic Inclusion Criteria
- •Target lesion is within a native coronary artery or major branch.
- •Target lesion is within a previously placed BMS or DES and does not extend further than 5 mm beyond either the proximal or distal edge of the stent.
- •Up to two (2) non-target lesions in non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before treatment of the target lesion. Successful treatment is defined as no greater than 30% residual stenosis by visual estimate, no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C, and Thrombolysis in Myocardial Infarction (TIMI) grade flow in the non-target lesion >
- •Target lesion is ≤ 26 mm in length.
- •Target lesion has diameter stenosis of > 50% and ≤ 99% by visual estimate.
- •Reference vessel diameter (RVD) is ≥ 2.00 mm and ≤ 4.50 mm.
- •Target lesion must be successfully pre-dilated/pre-treated. Note: Successful pre-dilation/pre-treatment is defined as dilation or pre-treatment that achieves stent expansion of approximately 80% of the distal RVD (at the discretion of the investigator) based on intravascular ultrasound (IVUS)/optical coherence tomography (OCT) and no greater than 30% residual stenosis by visual estimate and no dissection greater than NHLBI type C. TIMI grade flow in the target lesion must be >
- •Note: Atherectomy and cutting balloon are permitted for pre-treatment.
排除标准
- •Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.
- •ST-elevation myocardial infarction (STEMI) within 30 days.
- •Planned treatment of additional lesions in the target vessel, or more than two (2) non-target lesions within non-target vessels, during the index procedure.
- •Target lesion is located within a bifurcation with planned treatment of side branch vessel.
- •Target lesion is the 3rd or greater stent failure (i.e., more than two [2] layers of stent are present at any segment of the target lesion).
- •Target vessel had any previous vascular brachytherapy treatment or is planned to undergo brachytherapy at index procedure.
- •Previous PCI of the target vessel within 30 days.
- •Planned PCI of a non-target vessel, or a non-target lesion in the target vessel, within 30 days of randomization.
- •Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate [GFR] ≤ 30 ml/min/1.73 m² within 30 days of index procedure) or has undergone renal transplantation.
- •Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output.
- •History of active peptic ulcer or gastrointestinal bleeding within prior 6 months or other inability to comply with recommended duration of DAPT.
- •Subject is pregnant, breast-feeding, or a woman of childbearing potential who is not using appropriate contraceptives to avoid becoming pregnant.
- •Documented left ventricular ejection fraction (LVEF) < 25%.
- •Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
- •Angiographic Exclusion Criteria
- •Target lesion is a total occlusion or has evidence of thrombus.
- •Target lesion involves an unprotected left main.
- •Target lesion has > 30% residual stenosis by visual estimate or dissection greater than NHLBI type C after pre-dilation/pre-treatment.
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 months post-index procedure
次要结局
- Device success(Index Procedure)
- Lesion Success(Index Procedure)
- Procedure Success(Index Procedure)
- Composite Safety Endpoint(Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up)
- All-cause Mortality(Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up)
- Cardiovascular Mortality(Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up)
- MI(Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up)
- Clinically driven TLR, all TLR(Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up)
- Clinically driven TVR, all TVR, non-TVR(Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up)
- TLF(12 months)
- TVF(Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up)
- Stent Thrombosis(Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up)
- Bleeding(Prior to discharge, at 1, 6, and 12 months)
- Net adverse clinical events(Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up)
- Binary angiographic restenosis(12 months)
- In-stent percent diameter stenosis(12 months)
- In-segment percent diameter stenosis(12 months)
- In-stent LLL(12 months)
- In-segment LLL(12 months)
- In-stent MLD(12 months)
- In-segment MLD(12 months)
- OCT assessment of neointimal hyperplasia, neo-atherosclerosis, and stent malapposition(12 months)