Tack Optimized Balloon Angioplasty Post-Market Study

NCT05361967 | Terminated FDA Device

• 1 other identifier: IGT-00295
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (43)

• Target Lesion Patency - ATK, 6 Months

  6 Months

• Target Lesion Patency - ATK, 12 Months

  12 Months

• Target Lesion Patency - ATK, 24 Months

  24 Months

• Target Lesion Patency - BTK, 6 Months

  6 Months

• Target Lesion Patency - BTK, 12 Months

  12 Months

Study Arms (2)

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.

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.

Device: The Tack Endovascular System

Interventions

The Tack Endovascular System DEVICE

The Tack Endovascular System is designed to treat vascular dissections with Tack implant(s) following angioplasty.

ATK: Above-The-Knee; BTK: Below-The-Knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• BTK subjects must be RCC 4 or 5
• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Spectranetics Corporation: lead

Study Sites (10)

Advanced Heart and Vein Center - Thornton

Thornton, Colorado, 80023, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Palm Vascular Center Research

Fort Lauderdale, Florida, 33312, United States

Location

Munster Medical Research Foundation

Munster, Indiana, 46321, United States

Location

Advanced Heart and Vascular Institute of Hunterdon

Flemington, New Jersey, 08822, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Ascension St. John Heart and Vascular Center

Bartlesville, Oklahoma, 74006, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

North Dallas Research Associates

McKinney, Texas, 75069, United States

Location

MeSH Terms

Conditions

Dissection, Blood Vessel; Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 5, 2022
• Study Start: March 30, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-02

Locations

US (10)