Tack Optimized Balloon Angioplasty Post-Market Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 10
- 主要终点
- Procedure Success
研究概览
简要总结
The objective of this study is to obtain outcomes following dissection repair with the Tack Endovascular System in a broad population of patients undergoing endovascular treatment of lesions within the superficial femoral, popliteal, peroneal, and/or tibial arteries.
详细描述
The purpose of this post-market study is to obtain outcomes following dissection repair with the Tack Endovascular System in a broad population of patients undergoing endovascular treatment of lesions within the superficial femoral, popliteal, peroneal, and/or tibial arteries.
The Tack Endovascular System has been shown to effectively repair dissection and improve outcomes in clinical studies. Additional data, such as clinical utility of the Tack Endovascular System with the combined use of adjunctive therapies - other than balloon angioplasty alone, is needed.
Patients with claudication or CLI, who meet Rutherford classification 3, 4, or 5 criteria if ATK and Rutherford classification criteria 4 or 5 if BTK, who have undergone an above the knee (ATK) or below the knee (BTK) endovascular procedure utilizing adjunctive therapies other than balloon angioplasty alone which are then followed by PTA and IVUS, and have an arterial dissection requiring repair.
Approximately 100 subjects will be enrolled in up to 10 sites. The enrollment will be capped as follows:
- ATK: 50% of subjects
- BTK: 50% of subjects
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •General Inclusion Criteria
- •Age ≥ 18 years
- •Willingness to comply with study follow-up evaluations at the predefined time intervals
- •Signs the written informed consent
- •Meets Rutherford classification criteria:
- •ATK subjects can be RCC 3, 4 or 5
- •BTK subjects must be RCC 4 or 5
- •Angiographic Inclusion Criteria
- •A de novo or restenotic, non-stented target lesion with pre-intervention stenosis or occlusion (by visual estimate)
- •ATK Lesions:
- •must be in the superficial femoral and/or proximal popliteal (P1) arteries and
- •have a reference vessel diameter range of 3.5-6.0mm or 4.0-8.0mm.
- •BTK Lesions:
- •must be in the mid/distal popliteal (P2/P3), peroneal and/or tibial arteries and
- •have a reference vessel diameter range of 1.5-4.5mm Note: The mid popliteal artery begins at the superior aspect of the patella.
- •Post-IVUS Inclusion Criteria
- •Presence of an arterial dissection requiring repair per investigator judgement
- •ATK reference vessel diameter range of 3.5-6.0mm or 4.0-8.0mm
- •BTK reference vessel diameter range of 1.5-4.5mm
排除标准
- •General Exclusion Criteria
- •Subject is known to be breastfeeding, pregnant or planning to become pregnant during the study
- •Anticipated life expectancy < 12 months
- •Known COVID positive test within 14 days and active symptoms
- •Known renal disease that precludes contrast administration
- •Presence of a wound that in the opinion of the investigator cannot be healed with transmetatarsal amputation (TMA)
- •Contraindication to anticoagulation and/or antiplatelet therapy
- •Known allergy to nitinol (nickel and/or titanium)
- •Known allergy to contrast media that cannot be adequately pre-medicated prior to index procedure
- •Previous or planned surgical or interventional procedure within 3 days before or 30 days after the index procedure.
- •Note: this excludes successful inflow artery treatment within the same hospitalization or a documented pre-planned minor amputation.
- •Subject has any condition that in the opinion of the investigator precludes the subject from participation
- •Angiographic Exclusion Criteria
- •Residual diameter stenosis ≥30% (visual estimate) after PTA
- •Aneurysm, acute or sub-acute thrombosis in target lesion
- •Acute vessel occlusion after PTA not attributed to dissection
结局指标
主要结局
Procedure Success
时间窗: Measured on Day 0 of enrollment, upon completion of the Index Procedure
Defined as demonstrated target lesion patency (\<30% residual diameter stenosis, by visual estimate) without the use of a bail out stent within the target lesion and without the occurrence of MALE + POD upon completion of the index procedure.
次要结局
- Death(24 months)
- Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 12 Months(12 months)
- Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 24 Months(24 months)
- Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 24 Months(24 months)
- Target Limb Salvage(24 months)
- Rutherford Classification(24 months)
- Ankle and/or Toe Brachial Index(24 months)
- Wound Status(12 months)
- Target Lesion Patency - ATK, 6 Months(6 Months)
- Target Lesion Patency - ATK, 12 Months(12 Months)
- Target Lesion Patency - ATK, 24 Months(24 Months)
- Target Lesion Patency - BTK, 6 Months(6 Months)
- Target Lesion Patency - BTK, 12 Months(12 Months)
- Major Adverse Limb Events(24 months)
- Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 6 Months(6 months)
- Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 12 Months(12 months)
- Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 24 Months(24 months)
- Minor Amputation(24 months)
- Target Lesion Patency - BTK, 24 Months(24 Months)
- Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 6 Months(6 months)
- Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 12 Months(12 months)
- Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 24 Months(24 months)
- Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 6 Months(6 months)
- Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 6 Months(6 months)
- Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 12 Months(12 months)
- Adverse Events(Measured on Day 0 of enrollment, upon completion of the Index Procedure)
- Quality of Life / EuroQol EQ-5D-5L(24 months)