PAD - Peripheral Arterial DiseaseTOBA PMSNCT05361967
Tack Optimized Balloon Angioplasty Post-Market Study
An observational study of PAD - Peripheral Arterial Disease and PAD, run by Spectranetics Corporation at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PAD - Peripheral Arterial Disease, PAD, Dissection
- What is being tested?
- The Tack Endovascular System
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 10 sitesUnited States
- Study dates
- 30 Mar 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Ascension St. John Heart and Vascular Center
Bartlesville, Oklahoma, 74006
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, 08822
Palm Vascular Center Research
Fort Lauderdale, Florida, 33312
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Hartford Hospital
Hartford, Connecticut, 06106
North Dallas Research Associates
McKinney, Texas, 75069
Munster Medical Research Foundation
Munster, Indiana, 46321
The Miriam Hospital
Providence, Rhode Island, 02906
Advanced Heart and Vein Center - Thornton
Thornton, Colorado, 80023
About this study
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.
Read the 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.
- Conditions
- PAD - Peripheral Arterial Disease, PAD, Dissection, Arterial Dissection, Peripheral Arterial Disease, Peripheral Vascular Diseases
- Being tested
- The Tack Endovascular System
- Medical subject headings
- Dissection, Blood Vessel, Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Tack Endovascular SystemDevice
The Tack Endovascular System is designed to treat vascular dissections with Tack implant(s) following angioplasty.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The Tack Endovascular System | |
| 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. Receives: Device: The Tack Endovascular System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured on Day 0 of enrollment, upon completion of the Index Procedure
Secondary outcomes (43)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 Months
Death
All cause death
Measured: 6 months
Death
All cause death
Measured: 12 months
Death
All cause death
Measured: 24 months
Major Adverse Limb Events
Rate of MALE
Measured: 6 months
Major Adverse Limb Events
Rate of MALE
Measured: 12 months
Major Adverse Limb Events
Rate of MALE
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Target Limb Salvage
Freedom from above-ankle amputation.
Measured: 6 months
Target Limb Salvage
Freedom from above-ankle amputation.
Measured: 12 months
Target Limb Salvage
Freedom from above-ankle amputation.
Measured: 24 months
Minor Amputation
Freedom from target limb unplanned minor amputation
Measured: 6 months
Minor Amputation
Freedom from target limb unplanned minor amputation
Measured: 12 months
Minor Amputation
Freedom from target limb unplanned minor amputation
Measured: 24 months
Rutherford Classification
Changes from baseline in Rutherford classification
Measured: 6 months
Rutherford Classification
Changes from baseline in Rutherford classification
Measured: 12 months
Rutherford Classification
Changes from baseline in Rutherford classification
Measured: 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
Measured: 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
Measured: 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
Measured: 24 months
Wound Status
Changes from baseline in target limb wound status
Measured: 6 months
Wound Status
Changes from baseline in target limb wound status
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Adverse Events
Device related adverse events (AEs) upon completion of the index procedure
Measured: Measured on Day 0 of enrollment, upon completion of the Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start30 Mar 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Why it stopped: Terminated due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAD - Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectranetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361967
- Sponsor's protocol ID
- IGT-00295
- Acronym
- TOBA PMS
- Status last verified
- Feb 2024
- First submitted
- 25 Apr 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tack Optimized Balloon Angioplasty Post-Market Study
- ClinicalTrials.gov ID
- NCT05361967
- Acronym / sponsor ID
- TOBA PMS / IGT-00295
- Conditions
- PAD - Peripheral Arterial Disease, PAD, Dissection, Arterial Dissection, Peripheral Arterial Disease, Peripheral Vascular Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to slow enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Spectranetics CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATK: Above-The-Knee | – | Device: The Tack Endovascular SystemSubjects 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 | – | Device: The Tack Endovascular SystemSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (19 listed)
- 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:
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Tack Endovascular SystemThe Tack Endovascular System is designed to treat vascular dissections with Tack implant(s) following angioplasty. | Device | ATK: Above-The-Knee, BTK: Below-The-Knee |
Primary outcome
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.
43 secondary outcomes
Target Lesion Patency - ATK, 6 Months
Time frame: 6 Months
Target Lesion Patency - ATK, 12 Months
Time frame: 12 Months
Target Lesion Patency - ATK, 24 Months
Time frame: 24 Months
Target Lesion Patency - BTK, 6 Months
Time frame: 6 Months
Target Lesion Patency - BTK, 12 Months
Time frame: 12 Months
Target Lesion Patency - BTK, 24 Months
Time frame: 24 Months
Death
Time frame: 6 months
Death
Time frame: 12 months
Death
Time frame: 24 months
Major Adverse Limb Events
Time frame: 6 months
Major Adverse Limb Events
Time frame: 12 months
Major Adverse Limb Events
Time frame: 24 months
Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 6 Months
Time frame: 6 months
Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 6 Months
Time frame: 6 months
Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 12 Months
Time frame: 12 months
Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 12 Months
Time frame: 12 months
Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 24 Months
Time frame: 24 months
Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 24 Months
Time frame: 24 months
Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 6 Months
Time frame: 6 months
Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 6 Months
Time frame: 6 months
Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 12 Months
Time frame: 12 months
Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 12 Months
Time frame: 12 months
Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 24 Months
Time frame: 24 months
Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 24 Months
Time frame: 24 months
Target Limb Salvage
Time frame: 6 months
Target Limb Salvage
Time frame: 12 months
Target Limb Salvage
Time frame: 24 months
Minor Amputation
Time frame: 6 months
Minor Amputation
Time frame: 12 months
Minor Amputation
Time frame: 24 months
Rutherford Classification
Time frame: 6 months
Rutherford Classification
Time frame: 12 months
Rutherford Classification
Time frame: 24 months
Ankle and/or Toe Brachial Index
Time frame: 6 months
Ankle and/or Toe Brachial Index
Time frame: 12 months
Ankle and/or Toe Brachial Index
Time frame: 24 months
Wound Status
Time frame: 6 months
Wound Status
Time frame: 12 months
Quality of Life / EuroQol EQ-5D-5L
Time frame: 30 Days
Quality of Life / EuroQol EQ-5D-5L
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Terminated due to slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PAD - Peripheral Arterial Disease and PAD, run by Spectranetics Corporation at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Success (time frame: Measured on Day 0 of enrollment, upon completion of the Index Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.