Tack Optimized Balloon Angioplasty Post-Market Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PAD - Peripheral Arterial Disease
- Sponsor
- Spectranetics Corporation
- Enrollment
- 6
- Locations
- 10
- Primary Endpoint
- Procedure Success
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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 After enrollment of planned 100 subjects and interim analysis, the study may enroll up to 200 additional subjects at up to 20 additional sites, with each site limited to 15% of total enrollment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Procedure Success
Time Frame: 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.
Secondary Outcomes
- 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)