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Terminated due to slow enrollment
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATK: Above-The-Knee | 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. |
| |
| BTK: Below-The-Knee | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Tack Endovascular System | Device | The Tack Endovascular System is designed to treat vascular dissections with Tack implant(s) following angioplasty. |
|
| 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 |
| 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 |
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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:
Angiographic Inclusion Criteria
A de novo or restenotic, non-stented target lesion with pre-intervention stenosis or occlusion (by visual estimate)
ATK Lesions:
BTK Lesions:
Post-IVUS Inclusion Criteria
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
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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 lesions will be in the superficial femoral and/or proximal popliteal arteries; BTK lesions will be in the mid/distal popliteal, peroneal and/or tibial arteries. To be enrolled, subjects must meet all inclusion criteria and not meet any of the exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Heart and Vein Center - Thornton | Thornton | Colorado | 80023 | United States | ||
| Hartford Hospital |
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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 |
| Hartford |
| Connecticut |
| 06106 |
| United States |
| Palm Vascular Center Research | Fort Lauderdale | Florida | 33312 | United States |
| Munster Medical Research Foundation | Munster | Indiana | 46321 | United States |
| Advanced Heart and Vascular Institute of Hunterdon | Flemington | New Jersey | 08822 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Ascension St. John Heart and Vascular Center | Bartlesville | Oklahoma | 74006 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| North Dallas Research Associates | McKinney | Texas | 75069 | United States |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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