Tack Optimized Balloon Angioplasty Post-Market Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tack Optimized Balloon Angioplasty Post-Market Study

Conditions
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PAD, PAD - Peripheral Arterial Disease, Dissection, Arterial Dissection, Peripheral Arterial Disease, Peripheral Vascular Diseases

Intervention / Treatment
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* Device: The Tack Endovascular System


Participation Criteria
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Eligibility Criteria
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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: 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 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ATK: Above-The-Knee<br>Subjects with claudication (Rutherford 3) or CLTI (Rutherford 4 or 5), who have undergone an 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. ATK subjects will have baseline lesions in the superficial femoral and/or proximal popliteal arteries. | Device: The Tack Endovascular System<br>* The Tack Endovascular System is designed to treat vascular dissections with Tack implant(s) following angioplasty.<br>|
| BTK: Below-The-Knee<br>Subjects with CLTI (Rutherford 4 or 5), who have undergone an 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. BTK subjects will have baseline lesions in the mid/distal popliteal, peroneal and/or tibial arteries. | Device: The Tack Endovascular System<br>* The Tack Endovascular System is designed to treat vascular dissections with Tack implant(s) following angioplasty.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Success | 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. | Measured on Day 0 of enrollment, upon completion of the Index Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Patency - ATK, 6 Months | Defined as freedom from duplex ultrasound derived binary restenosis (PSVR ≥ 2.5) within the PTA treated segment, without reintervention | 6 Months | 
| Target Lesion Patency - ATK, 12 Months | Defined as freedom from duplex ultrasound derived binary restenosis (PSVR ≥ 2.5) within the PTA treated segment, without reintervention | 12 Months | 
| Target Lesion Patency - ATK, 24 Months | Defined as freedom from duplex ultrasound derived binary restenosis (PSVR ≥ 2.5) within the PTA treated segment, without reintervention | 24 Months | 
| Target Lesion Patency - BTK, 6 Months | Defined as presence of antegrade blood flow using duplex ultrasound within the PTA treated segment, without reintervention. | 6 Months | 
| Target Lesion Patency - BTK, 12 Months | Defined as presence of antegrade blood flow using duplex ultrasound within the PTA treated segment, without reintervention. | 12 Months | 
| Target Lesion Patency - BTK, 24 Months | Defined as presence of antegrade blood flow using duplex ultrasound within the PTA treated segment, without reintervention. | 24 Months | 
| Death | All cause death | 6 months | 
| Death | All cause death | 12 months | 
| Death | All cause death | 24 months | 
| Major Adverse Limb Events | Rate of MALE | 6 months | 
| Major Adverse Limb Events | Rate of MALE | 12 months | 
| Major Adverse Limb Events | Rate of MALE | 24 months | 
| Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 6 Months | TLR is defined as re-treatment by an invasive procedure, including atherectomy, angioplasty, intravascular lithotripsy, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen of the target vessel. TLR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as PSVR ≥ 2.5 by DUS or if angiography shows >50% diameter stenosis and there are symptoms attributable to increased ischemia or worsening of ABI (defined as deterioration by more than 0.15 from the maximum post-procedural level) that is clearly referable to the target lesion. | 6 months | 
| Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 6 Months | TLR is defined as re-treatment by an invasive procedure, including atherectomy, angioplasty, intravascular lithotripsy, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen of the target vessel. TLR will be classified as clinically driven or non-clinically driven by the investigator.Clinically driven is defined as a restenosis of ≥ 70% in the target vessel with wound persistence, new wounds or reoccurrence of ischemic rest pain. | 6 months | 
| Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 12 Months | TLR is defined as re-treatment by an invasive procedure, including atherectomy, angioplasty, intravascular lithotripsy, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen of the target vessel. TLR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as PSVR ≥ 2.5 by DUS or if angiography shows >50% diameter stenosis and there are symptoms attributable to increased ischemia or worsening of ABI (defined as deterioration by more than 0.15 from the maximum post-procedural level) that is clearly referable to the target lesion. | 12 months | 
| Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 12 Months | TLR is defined as re-treatment by an invasive procedure, including atherectomy, angioplasty, intravascular lithotripsy, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen of the target vessel. TLR will be classified as clinically driven or non-clinically driven by the investigator.Clinically driven is defined as a restenosis of ≥ 70% in the target vessel with wound persistence, new wounds or reoccurrence of ischemic rest pain. | 12 months | 
| Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 24 Months | TLR is defined as re-treatment by an invasive procedure, including atherectomy, angioplasty, intravascular lithotripsy, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen of the target vessel. TLR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as PSVR ≥ 2.5 by DUS or if angiography shows >50% diameter stenosis and there are symptoms attributable to increased ischemia or worsening of ABI (defined as deterioration by more than 0.15 from the maximum post-procedural level) that is clearly referable to the target lesion. | 24 months | 
| Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 24 Months | TLR is defined as re-treatment by an invasive procedure, including atherectomy, angioplasty, intravascular lithotripsy, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen of the target vessel. TLR will be classified as clinically driven or non-clinically driven by the investigator.Clinically driven is defined as a restenosis of ≥ 70% in the target vessel with wound persistence, new wounds or reoccurrence of ischemic rest pain. | 24 months | 
| Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 6 Months | TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. TVR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as PSVR ≥ 2.5 by DUS or if angiography shows >50% diameter stenosis and there are symptoms attributable to increased ischemia or worsening of ABI (defined as deterioration by more than 0.15 from the maximum post-procedural level) that is clearly referable to the target vessel. | 6 months | 
| Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 6 Months | TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. TVR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as a restenosis of ≥ 70% in the target vessel with wound persistence, new wounds or reoccurrence of ischemic rest pain. | 6 months | 
| Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 12 Months | TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. TVR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as PSVR ≥ 2.5 by DUS or if angiography shows >50% diameter stenosis and there are symptoms attributable to increased ischemia or worsening of ABI (defined as deterioration by more than 0.15 from the maximum post-procedural level) that is clearly referable to the target vessel. | 12 months | 
| Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 12 Months | TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. TVR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as a restenosis of ≥ 70% in the target vessel with wound persistence, new wounds or reoccurrence of ischemic rest pain. | 12 months | 
| Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 24 Months | TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. TVR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as PSVR ≥ 2.5 by DUS or if angiography shows >50% diameter stenosis and there are symptoms attributable to increased ischemia or worsening of ABI (defined as deterioration by more than 0.15 from the maximum post-procedural level) that is clearly referable to the target vessel. | 24 months | 
| Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 24 Months | TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. TVR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as a restenosis of ≥ 70% in the target vessel with wound persistence, new wounds or reoccurrence of ischemic rest pain. | 24 months | 
| Target Limb Salvage | Freedom from above-ankle amputation. | 6 months | 
| Target Limb Salvage | Freedom from above-ankle amputation. | 12 months | 
| Target Limb Salvage | Freedom from above-ankle amputation. | 24 months | 
| Minor Amputation | Freedom from target limb unplanned minor amputation | 6 months | 
| Minor Amputation | Freedom from target limb unplanned minor amputation | 12 months | 
| Minor Amputation | Freedom from target limb unplanned minor amputation | 24 months | 
| Rutherford Classification | Changes from baseline in Rutherford classification | 6 months | 
| Rutherford Classification | Changes from baseline in Rutherford classification | 12 months | 
| Rutherford Classification | Changes from baseline in Rutherford classification | 24 months | 
| Ankle and/or Toe Brachial Index | Changes from baseline in target limb Ankle Brachial Index (ABI) and/or Toe Brachial Index (TBI) measurement at post-procedure | 6 months | 
| Ankle and/or Toe Brachial Index | Changes from baseline in target limb Ankle Brachial Index (ABI) and/or Toe Brachial Index (TBI) measurement at post-procedure | 12 months | 
| Ankle and/or Toe Brachial Index | Changes from baseline in target limb Ankle Brachial Index (ABI) and/or Toe Brachial Index (TBI) measurement at post-procedure | 24 months | 
| Wound Status | Changes from baseline in target limb wound status | 6 months | 
| Wound Status | Changes from baseline in target limb wound status | 12 months | 
| Quality of Life / EuroQol EQ-5D-5L | Changes from baseline in EQ-5D-5L questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. | 30 Days | 
| Quality of Life / EuroQol EQ-5D-5L | Changes from baseline in EQ-5D-5L questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. | 6 months | 
| Quality of Life / EuroQol EQ-5D-5L | Changes from baseline in EQ-5D-5L questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. | 12 months | 
| Quality of Life / EuroQol EQ-5D-5L | Changes from baseline in EQ-5D-5L questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. | 24 months | 
| Adverse Events | Device related adverse events (AEs) upon completion of the index procedure | Measured on Day 0 of enrollment, upon completion of the Index Procedure |