NCT02802306已完成不适用
Tack Optimized Drug Coated Balloon Angioplasty in the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 19
- 主要终点
- Safety - Freedom from the occurrence of any new-onset major adverse event(s)
研究概览
简要总结
This is an Outside the United States, post-CE Mark, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System. This study will evaluate subjects with PAD who receive PTA (with a drug-coated balloon (DCB)) in the SFA and in popliteal arteries, ranging in diameter from 2.5mm to 6.0mm and lesion lengths of ≥20mm and ≤150mm, and have a resulting dissection(s) type(s) A through F. TOBA III will also evaluate the safety and efficacy of the device when used to treat a sub-group presenting with longer lesions of >150mm and ≤250mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject must meet all of the following inclusion criteria to be eligible for enrollment:
- •Male or non-pregnant Female ≥ 18 years of age at the time of consent
- •Female subjects of childbearing potential must have a negative pregnancy test prior to treatment and must use some form of contraception through the duration of the study
- •Target limb requires no additional treatment aside from the target lesion and the iliac artery(ies) during the index procedure
- •Subject or has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. If the subject possesses the ability to understand and provide informed consent but due to physical inability, the subject cannot sign the ICF, an impartial witness may sign on behalf of the subject
- •Willing to comply with all required follow-up visits
- •Rutherford Classification 2, 3 or 4
- •Estimated life expectancy >1 year
- •Eligible for standard surgical repair, if necessary
- •Subject is ambulatory (assistive devices such as a cane or walker is acceptable
排除标准
- •Subject must NOT meet any of the following exclusion criteria to be eligible for enrollment:
- •Rutherford Classification 0, 1, 5 or 6
- •Is pregnant or refuses to use contraception through the duration of the study
- •Previous infrainguinal bypass graft in the target limb
- •Planned amputation on the target limb
- •Systemic infection or infection within the target limb and/or immunocompromised
- •Endovascular or surgical procedure (not including diagnostic procedures) on the target limb within 30 days prior to or within 30 days after the index procedure
- •Endovascular or surgical procedure (not including diagnostic procedures) on the non-target limb within 14 days prior to the index procedure or planned procedure within 30 days after the index procedure
- •Prior coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) procedure within 30 days prior to the index procedure or planned CABG/PCI within 30 days after the index procedure
- •Any other previous or planned surgical or endovascular procedure (not including diagnostic procedures) within 14 days prior to or 30 days post index procedure
- •Planned atherectomy, cryoplasty, stenting or any other treatment (with the exception of a crossing device) of the target lesion other than PTA during the index procedure
- •Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80,000/microliter or greater than 500,000/microliter
- •Known hypersensitivity or allergy to antiplatelet or anticoagulant therapy
- •Myocardial infarction within 30 days prior to enrollment
- •History of stroke within 90 days prior to enrollment
- •Serum creatinine of >2.5 mg/dL
- •Requires treatment of tibial or outflow vessels at the index procedure, which include the P2 and P3 segments of the popliteal artery and the tibioperoneal vessels
- •Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)
- •Participating in another ongoing investigational clinical trial that has not completed its primary endpoint
- •Has other comorbidities that, in the opinion of the investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments
- •Known hypersensitivity or allergy to contrast agents that cannot be medically managed
- •Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved
结局指标
主要结局
Safety - Freedom from the occurrence of any new-onset major adverse event(s)
时间窗: 30 days
Freedom from the occurrence of any new-onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days.
Efficacy - Primary Patency
时间窗: 12 months
Primary patency defined as freedom from CEC adjudicated clinically driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as PSVR \>2.5:1).
次要结局
未报告次要终点
研究者
研究点 (19)
Loading locations...
相似试验
已完成
不适用
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal ArteriesPeripheral Artery DiseaseNCT02522884Philips Clinical & Medical Affairs Global213
已完成
不适用
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee ArteriesPeripheral Arterial DiseaseNCT02942966Philips Clinical & Medical Affairs Global233
已完成
不适用
Tack Optimized Balloon Angioplasty (TOBA) StudyPeripheral Vascular DiseaseNCT01663818Philips Clinical & Medical Affairs Global138
进行中（未招募）
不适用
Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience From 2009 to 2015Ischaemic Heart DiseaseNCT03603210Norfolk and Norwich University Hospitals NHS Foundation Trust1,000
已完成
不适用
Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery DiseaseAngioplasty, BalloonCatheterization, PeripheralPopliteal ArteryFemoral ArteryNCT02648334Seung-Whan Lee, M.D., Ph.D.443