Clinical trial NCT05361967: Tack Optimized Balloon Angioplasty Post-Market Study
Official title: Tack Optimized Balloon Angioplasty Post-Market Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: PAD - Peripheral Arterial Disease
PAD
Dissection
Arterial Dissection
Peripheral Arterial Disease
Peripheral Vascular Diseases
Lead sponsor: Spectranetics Corporation
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: The objective of this study is to obtain outcomes following dissection repair with the Tack Endovascular System in a broad population of patients undergoing endovascular treatment of lesions within the superficial femoral, popliteal, peroneal, and/or tibial arteries.

Detailed description: The purpose of this post-market study is to obtain outcomes following dissection repair with the Tack Endovascular System in a broad population of patients undergoing endovascular treatment of lesions within the superficial femoral, popliteal, peroneal, and/or tibial arteries.

The Tack Endovascular System has been shown to effectively repair dissection and improve outcomes in clinical studies. Additional data, such as clinical utility of the Tack Endovascular System with the combined use of adjunctive therapies - other than balloon angioplasty alone, is needed.

Patients with claudication or CLI, who meet Rutherford classification 3, 4, or 5 criteria if ATK and Rutherford classification criteria 4 or 5 if BTK, who have undergone an above the knee (ATK) or below the knee (BTK) endovascular procedure utilizing adjunctive therapies other than balloon angioplasty alone which are then followed by PTA and IVUS, and have an arterial dissection requiring repair.

Approximately 100 subjects will be enrolled in up to 10 sites. The enrollment will be capped as follows:

* ATK: 50% of subjects
* BTK: 50% of subjects

After enrollment of planned 100 subjects and interim analysis, the study may enroll up to 200 additional subjects at up to 20 additional sites, with each site limited to 15% of total enrollment.

Eligibility criteria: Inclusion Criteria:

General Inclusion Criteria

1. Age ≥ 18 years
2. Willingness to comply with study follow-up evaluations at the predefined time intervals
3. Signs the written informed consent
4. Meets Rutherford classification criteria:

   1. ATK subjects can be RCC 3, 4 or 5
   2. BTK subjects must be RCC 4 or 5

Angiographic Inclusion Criteria

1. A de novo or restenotic, non-stented target lesion with pre-intervention stenosis or occlusion (by visual estimate)
2. ATK Lesions:

   1. must be in the superficial femoral and/or proximal popliteal (P1) arteries and
   2. have a reference vessel diameter range of 3.5-6.0mm or 4.0-8.0mm.
3. BTK Lesions:

   1. must be in the mid/distal popliteal (P2/P3), peroneal and/or tibial arteries and
   2. 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

1. Presence of an arterial dissection requiring repair per investigator judgement
2. ATK reference vessel diameter range of 3.5-6.0mm or 4.0-8.0mm
3. BTK reference vessel diameter range of 1.5-4.5mm

Exclusion Criteria:

General Exclusion Criteria

1. Subject is known to be breastfeeding, pregnant or planning to become pregnant during the study
2. Anticipated life expectancy \< 12 months
3. Known COVID positive test within 14 days and active symptoms
4. Known renal disease that precludes contrast administration
5. Presence of a wound that in the opinion of the investigator cannot be healed with transmetatarsal amputation (TMA)
6. Contraindication to anticoagulation and/or antiplatelet therapy
7. Known allergy to nitinol (nickel and/or titanium)
8. Known allergy to contrast media that cannot be adequately pre-medicated prior to index procedure
9. 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.
10. Subject has any condition that in the opinion of the investigator precludes the subject from participation

Angiographic Exclusion Criteria

1. Residual diameter stenosis ≥30% (visual estimate) after PTA
2. Aneurysm, acute or sub-acute thrombosis in target lesion
3. Acute vessel occlusion after PTA not attributed to dissection

Primary outcomes:
measure: Procedure Success
timeFrame: Measured on Day 0 of enrollment, upon completion of the Index Procedure
Secondary outcomes:
measure: Target Lesion Patency - ATK, 6 Months
timeFrame: 6 Months
measure: Target Lesion Patency - ATK, 12 Months
timeFrame: 12 Months
measure: Target Lesion Patency - ATK, 24 Months
timeFrame: 24 Months
measure: Target Lesion Patency - BTK, 6 Months
timeFrame: 6 Months
measure: Target Lesion Patency - BTK, 12 Months
timeFrame: 12 Months
measure: Target Lesion Patency - BTK, 24 Months
timeFrame: 24 Months
measure: Death
timeFrame: 6 months
measure: Death
timeFrame: 12 months
measure: Death
timeFrame: 24 months
measure: Major Adverse Limb Events
timeFrame: 6 months
measure: Major Adverse Limb Events
timeFrame: 12 months
measure: Major Adverse Limb Events
timeFrame: 24 months
measure: Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 6 Months
timeFrame: 6 months
measure: Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 6 Months
timeFrame: 6 months
measure: Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 12 Months
timeFrame: 12 months
measure: Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 12 Months
timeFrame: 12 months
measure: Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 24 Months
timeFrame: 24 months
measure: Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 24 Months
timeFrame: 24 months
measure: Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 6 Months
timeFrame: 6 months
measure: Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 6 Months
timeFrame: 6 months
measure: Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 12 Months
timeFrame: 12 months
measure: Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 12 Months
timeFrame: 12 months
measure: Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 24 Months
timeFrame: 24 months
measure: Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 24 Months
timeFrame: 24 months
measure: Target Limb Salvage
timeFrame: 6 months
measure: Target Limb Salvage
timeFrame: 12 months
measure: Target Limb Salvage
timeFrame: 24 months
measure: Minor Amputation
timeFrame: 6 months
measure: Minor Amputation
timeFrame: 12 months
measure: Minor Amputation
timeFrame: 24 months
measure: Rutherford Classification
timeFrame: 6 months
measure: Rutherford Classification
timeFrame: 12 months
measure: Rutherford Classification
timeFrame: 24 months
measure: Ankle and/or Toe Brachial Index
timeFrame: 6 months
measure: Ankle and/or Toe Brachial Index
timeFrame: 12 months
measure: Ankle and/or Toe Brachial Index
timeFrame: 24 months
measure: Wound Status
timeFrame: 6 months
measure: Wound Status
timeFrame: 12 months
measure: Quality of Life / EuroQol EQ-5D-5L
timeFrame: 30 Days
measure: Quality of Life / EuroQol EQ-5D-5L
timeFrame: 6 months
measure: Quality of Life / EuroQol EQ-5D-5L
timeFrame: 12 months
measure: Quality of Life / EuroQol EQ-5D-5L
timeFrame: 24 months
measure: Adverse Events
timeFrame: Measured on Day 0 of enrollment, upon completion of the Index Procedure
Other outcomes:
Locations:
city: Thornton
country: United States
facility: Advanced Heart and Vein Center - Thornton
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Palm Vascular Center Research
state: Florida
city: Munster
country: United States
facility: Munster Medical Research Foundation
state: Indiana
city: Flemington
country: United States
facility: Advanced Heart and Vascular Institute of Hunterdon
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Bartlesville
country: United States
facility: Ascension St. John Heart and Vascular Center
state: Oklahoma
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
Study officials:
References: