Peripheral Artery Disease Clinical Trial
Official title:
Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment
Prospective, multicenter, randomized clinical trial, Follow-up at 1-, 6- and 12 months
This clinical investigation is first of all designed to demonstrate the safety and
effectiveness of the MAGIC EXPLORER stent system. The primary objectives of the study are to
evaluate the safety and 6-month patency of the bioabsorbable MAGIC EXPLORER stent in
patients with stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries.
Secondary endpoints are the procedural success, patency at all follow-ups, late lumen loss
and limb-salvage rate. Peri-procedural complications (within 24 hours) will be evaluated.
Furthermore, data of the balloon catheter PLEON EXPLORER will be collected to demonstrate
its effectiveness and safety.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05712395 -
The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease
|
N/A | |
| Active, not recruiting |
NCT04534257 -
Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore
|
N/A | |
| Recruiting |
NCT04511234 -
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal 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 | |
| Completed |
NCT02554266 -
Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
|
||
| Completed |
NCT03921905 -
Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
|
||
| Not yet recruiting |
NCT06369350 -
Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion
|
Early Phase 1 | |
| Recruiting |
NCT04545268 -
Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance
|
N/A | |
| Recruiting |
NCT02389023 -
Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
|
N/A | |
| Completed |
NCT02539940 -
Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
|
||
| Completed |
NCT02542267 -
In-Stent Restenosis Post-Approval Study
|
N/A | |
| Completed |
NCT02522884 -
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries
|
N/A | |
| Completed |
NCT02563535 -
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia
|
Phase 4 | |
| Completed |
NCT02145065 -
First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)
|
N/A | |
| Completed |
NCT02228564 -
BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease
|
N/A | |
| Completed |
NCT02262949 -
A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System
|
N/A | |
| Completed |
NCT01743872 -
Optical Imaging Measurement of Intravascular Solution Efficacy Trial
|
N/A | |
| Recruiting |
NCT01424020 -
Walking Estimated Limitation Calculated by History - Study 2
|
Phase 4 | |
| Active, not recruiting |
NCT01597453 -
NOR-SYS: The Norwegian Stroke in the Young Study
|
N/A |