Tack Optimized Balloon Angioplasty Post-Market Study (TOBA PMS)

Spectranetics

Status: Enrolling

Conditions: PAD; PAD - Peripheral Arterial Disease; Peripheral Vascular Diseases; Peripheral Arterial Disease; Dissection; Arterial Dissection

Treatments: Device: The Tack Endovascular System

Study type: Observational

Funder types: Industry

Identifiers

NCT05361967

IGT-00295

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

ATK: Above-The-Knee

Description:

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.

Treatment:

Device: The Tack Endovascular System

BTK: Below-The-Knee

Description:

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.

Treatment:

Device: The Tack Endovascular System