Peripheral Arterial Disease Clinical Trial
Official title:
Tack Optimized Balloon Angioplasty Post-Market Study
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
| Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
| Recruiting |
NCT03506633 -
Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
|
N/A | |
| Active, not recruiting |
NCT03506646 -
Dietary Nitrate Supplementation and Thermoregulation
|
N/A | |
| Active, not recruiting |
NCT04677725 -
NEtwork to Control ATherothrombosis (NEAT Registry)
|
||
| Recruiting |
NCT05961943 -
RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
|
N/A | |
| Recruiting |
NCT06047002 -
Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
|
||
| Completed |
NCT03185052 -
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
|
N/A | |
| Recruiting |
NCT05992896 -
A Study of Loco-Regional Liposomal Bupivacaine Injection
|
Phase 4 | |
| Completed |
NCT04635501 -
AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial
|
N/A | |
| Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
| Withdrawn |
NCT03994185 -
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
|
N/A | |
| Withdrawn |
NCT03538392 -
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
|
||
| Recruiting |
NCT02915796 -
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
|
Phase 1 | |
| Active, not recruiting |
NCT02900924 -
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
|
||
| Completed |
NCT02901847 -
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
|
N/A | |
| Withdrawn |
NCT02126540 -
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
|
N/A | |
| Not yet recruiting |
NCT02455726 -
Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
|
N/A | |
| Not yet recruiting |
NCT02387450 -
Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
|
Phase 2/Phase 3 | |
| Completed |
NCT02022423 -
Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease
|
N/A |