NCT05361967

Tack Optimized Balloon Angioplasty Post-Market Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Spectranetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2023-03-30
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2022-05-05
• Last updated: 2024-08-09

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study