Clinical trials: Infrapopliteal Arterial Occlusive Disease
Chronic Limb-Threatening Ischemia
Esprit BTK Post-Approval Study
The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients…
- Trial name
- EspritBTKPAS (NCT06656364)
- Testing
- Esprit BTK System
- Where
- 39 sites in United States, Hong Kong and 2 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Diseases
Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease
The primary objective of this study is to compare the performance of the CYPHER SELECTTM + Sirolimus-eluting Balloon-expandable Coronary and Infrapopliteal Stent over balloon angioplasty in de novo and restenotic native below the…
- Trial name
- ACHILLES (NCT00640770)
- Testing
- balloon angioplasty, drug eluting stent
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Cordis US Corp.
Atherosclerosis, Arteriosclerosis
BIOLUX P-II First-in-Man Study to Compare the Passeo-18 Lux DRB Against POBA in Infrapopliteal Arteries
A prospective, multicentric, randomized controlled trial to assess the safety and performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18 PTA balloon catheter for the treatment of…
- Conditions
- Atherosclerosis, Arteriosclerosis, Vascular Disease, Peripheral Artery Disease
- Trial name
- BIOLUX P-II (NCT01867736)
- Testing
- Passeo-18 Lux DRB, Standard PTA (POBA)
- Where
- 6 sites in Austria, Belgium and 1 more
- Volunteers
- 72 people
- Sponsor
- Biotronik AG
Critical Limb Ischemia (CLI)
LIFE-BTK Randomized Controlled Trial
The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed…
- Trial name
- LIFE-BTK (NCT04227899)
- Testing
- Esprit BTK Device, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 50 sites in United States, Australia and 4 more
- Volunteers
- 261 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia
MOTIV BTK Randomized Controlled Trial
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
- Trial name
- NCT05406622
- Testing
- MOTIV Sirolimus-Eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 26 sites in United States, Germany
- Volunteers
- 292 people
- Sponsor
- REVA Medical, Inc.
Peripheral Arterial Disease
A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee
The purpose of this study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS). The TSS is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal…
- Trial name
- DEEPER OUS (NCT03807531)
- Testing
- Temporary Spur Stent System
- Where
- 6 sites in Germany, New Zealand and 1 more
- Volunteers
- 100 people
- Sponsor
- ReFlow Medical, Inc.