Clinical trials: Superficial Femoral Artery Occlusion
Peripheral Arterial Disease, Peripheral Vascular Disease
Clinical Pilot-Study of ProEndoTecc Vascular Grafts as Superficial Femoral Artery Bypass / Interponate
This is a multi-center, clinical pilot-study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as superficial femoral artery bypass/interponate.
- Trial name
- NCT01095237
- Testing
- ProEndoTecc Vascular Graft
- Where
- 12 sites in Germany
- Volunteers
- 33 people
- Sponsor
- NonWoTecc Medical GmbH
Atherosclerosis
Study Comparing Legflow Versus Bare Balloon Angioplasty for Treatment of Atherosclerotic Disease
A randomized multicentric study for endovascular treatment of patients with obstructive disease in the SFA (superficial femoral artery) and in the popliteal artery.
- Trial name
- NCT02710656
- Testing
- Legflow® balloon, Standard PTA
- Where
- 9 sites in Belgium, France and 1 more
- Volunteers
- 130 people
- Sponsor
- Cardionovum GmbH
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
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
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
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
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.
Arterial Occlusive Diseases, Atherosclerosis
Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery
The EMINENT study is a prospective, multi-center study evaluating the effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in the femoropopliteal arteries.
- Conditions
- Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis
- Trial name
- EMINENT (NCT02921230)
- Testing
- Peripheral stenting
- Where
- 60 sites in Austria, Belgium and 8 more
- Volunteers
- 775 people
- Sponsor
- Boston Scientific Corporation
Femoropopliteal Occlusive Disease, Peripheral Artery Disease
Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter.
Assessing the safety and effectiveness of the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral (SFA) and/or popliteal arteries.
- Trial name
- KANSHAS-1 (NCT02939924)
- Testing
- Kanshas DCB
- Where
- 6 sites in Belgium, Germany
- Volunteers
- 50 people
- Sponsor
- Terumo Europe N.V.
Angioplasty, Peripheral Arterial Disease
European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.
The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions.
- Conditions
- Angioplasty, Peripheral Arterial Disease, Drug-eluting Balloon, Femoral Artery
- Trial name
- LUMIFOLLOW (NCT04743180)
- Testing
- LUMINOR© Paclitaxel eluting balloon
- Where
- 15 sites in France
- Volunteers
- 500 people
- Sponsor
- iVascular S.L.U.
Peripheral Artery Disease
A Study of the SMART Stent in the Treatment SFA Disease.
The main objective of this study is to assess the safety and performance of the sirolimus coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the treatment of obstructive superficial femoral…
- Trial name
- SIROCCO (NCT00232869)
- Testing
- drug-eluting stent, bare-metal stent
- Where
- Germany
- Volunteers
- 93 people
- Sponsor
- Cordis US Corp.
Peripheral Vascular Diseases
Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
The purpose of this study is to confirm the safety and performance of the 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral Artery.
- Trial name
- NCT01263665
- Testing
- 25 cm GORE® VIABAHN®
- Volunteers
- 71 people
- Sponsor
- W.L.Gore & Associates
Peripheral Vascular Disease
The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions
To evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) in…
- Trial name
- NCT00814970
- Testing
- Complete SE Vascular Stent System
- Where
- 4 sites in United States
- Volunteers
- 196 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease
Evaluation of the GORE TIGRIS Vascular Stent
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial…
- Trial name
- TIGRIS (NCT01576055)
- Testing
- TIGRIS Vascular Stent, BARD LifeStent
- Where
- 34 sites in United States
- Volunteers
- 267 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
The aim of this study is to demonstrate the superiority in safety and efficacy of the Legflow DCB vs standard uncoated POBA in a randomized controlled (RCT) for treatment of patients with symptomatic peripheral artery disease…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Angiopathy, Peripheral
- Trial name
- SIGNATURE (NCT04971772)
- Where
- 11 sites in Brazil, Germany and 1 more
- Volunteers
- 150 people
- Sponsor
- Cardionovum GmbH
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 Artery Disease, Vascular Disease
In-Stent Restenosis Post-Approval Study
The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
- Trial name
- NCT02542267
- Testing
- Gore VIABAHN Endoprosthesis
- Where
- 23 sites in United States, Germany and 2 more
- Volunteers
- 108 people
- Sponsor
- W.L.Gore & Associates
Peripheral Vascular Diseases
ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries
The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.
- Trial name
- NCT00180505
- Testing
- ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent
- Where
- 13 sites in Austria, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- Abbott Medical Devices
Atherosclerosis of Native Arteries of the Extremities
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project
To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
- Trial name
- MAJESTIC (NCT01820637)
- Testing
- The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
- Where
- 13 sites in Australia, Austria and 3 more
- Volunteers
- 57 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