Spectranetics Corporation
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.
PAD - Peripheral Arterial Disease
PAD
Dissection
Arterial Dissection
Peripheral Arterial Disease
Peripheral Vascular Diseases
The Tack Endovascular System
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 Type : | Observational |
Estimated Enrollment : | 100 participants |
Official Title : | Tack Optimized Balloon Angioplasty Post-Market Study |
Actual Study Start Date : | March 30, 2023 |
Estimated Primary Completion Date : | February 2025 |
Estimated Study Completion Date : | February 2026 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Advanced Heart and Vein Center - Thornton
Thornton, Colorado, United States, 80023
Recruiting
Hartford Hospital
Hartford, Connecticut, United States, 06106
Recruiting
Palm Vascular Center Research
Fort Lauderdale, florida, United States, 33312
Recruiting
Munster Medical Research Foundation
Munster, Indiana, United States, 46321
Recruiting
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, United States, 08822
Not yet recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Not yet recruiting
Ascension St. John Heart and Vascular Center
Bartlesville, Oklahoma, United States, 74006
Recruiting
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Recruiting
University of Texas Southwestern Medical Center
dallas, Texas, United States, 75390
Not yet recruiting
North Dallas Research Associates
McKinney, Texas, United States, 75069