Clinical trials: Superficial Femoral Artery Occlusion
Peripheral Artery Disease
ILLUMENATE Pivotal Post-Approval Study (PAS)
The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate…
- Trial name
- NCT03421561
- Testing
- Stellarex 0.035" OTW Drug-coated Angioplasty Balloon, EverCross™ 0.035 PTA Balloon Catheter
- Where
- 41 sites in United States, Austria
- Volunteers
- 300 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease
TurboHawk™ Japan Trial in Patients With PAD
The objective of this study is to evaluate the safety and effectiveness of the TurboHawk for the treatment of peripheral arterial disease (PAD) in the superficial femoral and/or the popliteal arteries with the Japanese population.
- Trial name
- NCT02169921
- Testing
- Atherectomy Catheter
- Where
- 2 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Medtronic Endovascular
Femoral Artery Stenosis, Popliteal Artery Stenosis
MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the interventional treatment of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the proximal popliteal artery…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- MDT-2113 SFA (NCT01947478)
- Testing
- MDT-2113 Drug-Eluting Balloon, Standard angioplasty balloon
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Medtronic Endovascular
Arterial Occlusive Diseases
The Study to Compare the Treatment of Angioplasty and Stents in SFA Occlusions.
The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.
- Trial name
- DURAVEST (NCT00289055)
- Testing
- stent, angioplasty
- Where
- Netherlands
- Volunteers
- 10 people
- Sponsor
- Cordis US Corp.
Peripheral Vascular Diseases
GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.
- Trial name
- NCT00228384
- Testing
- GORE VIABAHN Endoprosthesis, Bare Nitinol Stent
- Where
- 15 sites in United States
- Volunteers
- 148 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)
The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral…
- Trial name
- NCT03847233
- Testing
- Jetstream Atherectomy System
- Where
- 5 sites in Japan
- Volunteers
- 31 people
- Sponsor
- Boston Scientific Corporation
Femoral Artery Stenosis, Femoral Artery Occlusion
A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries
To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion of the superficial femoral and popliteal arteries.
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Stenosis of Popliteal Arteries, Occlusion of Popliteal Arteries
- Trial name
- NCT02720003
- Testing
- LTX DCB
- Where
- 14 sites in China
- Volunteers
- 148 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease
HORIZON Prospective Clinical Investigation
The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX \& PULL in a prospective investigation for the treatment of…
- Trial name
- NCT05234164
- Testing
- EXIST 6F NiTi Stent System FLEX, EXIST 6F NiTi Stent System PULL
- Where
- 2 sites in Italy, Poland
- Volunteers
- 69 people
- Sponsor
- Qmedics AG
Peripheral Artery Disease, Peripheral Vascular Disease
Absolute Pro® MOMENTUM™
To evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the treatment of subjects with atherosclerotic de novo or…
- Trial name
- MOMENTUM (NCT01444378)
- Testing
- Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems
- Where
- United States
- Volunteers
- 141 people
- Sponsor
- Abbott Medical Devices
Atherosclerosis
Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA
This clinical study is a prospective, non-randomized, multicenter, single-arm study to demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System (Jetstream) used during percutaneous peripheral…
- Trial name
- NCT03455855
- Testing
- Jetstream System
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Boston Scientific Corporation
Superficial Femoral Artery Occlusions
The Study to Compare SMART Nitinol Stent and Balloon Angioplasty
This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ Nitinol Stent System compared to balloon angioplasty. Patients will be randomized on a 1:1 basis.
- Trial name
- SIT-UP (NCT00309595)
- Testing
- stent, balloon
- Where
- 2 sites in Switzerland
- Volunteers
- 50 people
- Sponsor
- Cordis US Corp.
Total Atherosclerotic Occlusion of Femoral Artery
Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II
Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.
- Trial name
- CONNECTII (NCT01537302)
- Testing
- CTO crossing in femoropopliteal arteries CONNECT II
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 100 people
- Sponsor
- Avinger, Inc.
Atherosclerosis
The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population
The purpose of this study is to confirm that the IN.PACT Admiral is safe and effective for the interventional treatment of new and non-stented restenotic lesions in the superficial femoral artery (SFA) and proximal popliteal…
- Trial name
- NCT02118532
- Testing
- IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
- Where
- 15 sites in China
- Volunteers
- 143 people
- Sponsor
- Medtronic Endovascular
Peripheral Artery Disease
Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified…
- Trial name
- KAIZEN (NCT05529472)
- Testing
- Peripheral Orbital Atherectomy System (OAS)
- Where
- 12 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease
PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE
To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon Catheter in subjects with atherosclerotic peripheral artery disease of the superficial femoral and popliteal arteries.
- Trial name
- PRELUDE (NCT03001700)
- Testing
- Serranator™ Alto PTA Serration Balloon Catheter
- Where
- 4 sites in Austria, New Zealand and 1 more
- Volunteers
- 25 people
- Sponsor
- Cagent Vascular LLC
Peripheral Arterial Disease
Remedy, Biodegradable Peripheral Stent Registry
This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries.
- Trial name
- NCT01420120
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- be Medical
Peripheral Arterial Disease
Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent in the Superficial Femoral Artery
This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions.
- Trial name
- BOSS (NCT01499342)
- Where
- 2 sites in Belgium
- Volunteers
- 435 people
- Sponsor
- be Medical
Atherosclerosis, Peripheral Vascular Disease
A Safety and Efficacy Study of the Dynalink®-E Everolimus Eluting Peripheral Stent System
The purpose of this first-in-man study is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native…
- Trial name
- STRIDES (NCT00475566)
- Testing
- Dynalink®-E everolimus-eluting peripheral stent, Dynalink®-E, everolimus-eluting peripheral stent
- Where
- 10 sites in Austria, Belgium and 2 more
- Volunteers
- 104 people
- Sponsor
- Abbott Medical Devices
Peripheral Vascular Disease, Peripheral Arterial Disease
EVERO Drug-coated Balloon (DCB) Randomized Trial
The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero…
- Trial name
- NCT07144150
- Testing
- Evero DCB, Paclitaxel DCB
- Where
- 12 sites in United States
- Volunteers
- 410 people
- Sponsor
- Cook Research Incorporated
Peripheral Arterial Disease, Claudication
ILLUMENATE EU Randomized Clinical Trial
This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the…
- Trial name
- EU RCT (NCT01858363)
- Testing
- CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter, Bare Percutaneous Transluminal Angioplasty Balloon Catheter
- Where
- Germany
- Volunteers
- 294 people
- Sponsor
- Spectranetics Corporation