An observational study in PAD - Peripheral Arterial Disease, PAD and Dissection, sponsored by Spectranetics Corporation. Terminated at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Spectranetics Corporation · Observational
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.
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.
General Inclusion Criteria
Meets Rutherford classification criteria:
Angiographic Inclusion Criteria
ATK Lesions:
BTK Lesions:
Post-IVUS Inclusion Criteria
Exclusion Criteria:
General Exclusion Criteria
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.
Angiographic Exclusion Criteria
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
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
The Tack Endovascular System is designed to treat vascular dissections with Tack implant(s) following angioplasty.
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.
Time frame: Measured on Day 0 of enrollment, upon completion of the Index Procedure
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 Months
Death
All cause death
Time frame: 6 months
Death
All cause death
Time frame: 12 months
Death
All cause death
Time frame: 24 months
Major Adverse Limb Events
Rate of MALE
Time frame: 6 months
Major Adverse Limb Events
Rate of MALE
Time frame: 12 months
Major Adverse Limb Events
Rate of MALE
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Target Limb Salvage
Freedom from above-ankle amputation.
Time frame: 6 months
Target Limb Salvage
Freedom from above-ankle amputation.
Time frame: 12 months
Target Limb Salvage
Freedom from above-ankle amputation.
Time frame: 24 months
Minor Amputation
Freedom from target limb unplanned minor amputation
Time frame: 6 months
Minor Amputation
Freedom from target limb unplanned minor amputation
Time frame: 12 months
Minor Amputation
Freedom from target limb unplanned minor amputation
Time frame: 24 months
Rutherford Classification
Changes from baseline in Rutherford classification
Time frame: 6 months
Rutherford Classification
Changes from baseline in Rutherford classification
Time frame: 12 months
Rutherford Classification
Changes from baseline in Rutherford classification
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 months
Wound Status
Changes from baseline in target limb wound status
Time frame: 6 months
Wound Status
Changes from baseline in target limb wound status
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Adverse Events
Device related adverse events (AEs) upon completion of the index procedure
Time frame: Measured on Day 0 of enrollment, upon completion of the Index Procedure
This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Spectranetics Corporation