Clinical trials: Femoral Artery Stenosis
Femoral Artery Stenosis, Iliac Artery Stenosis
Retrospective Study of the Uni-Graft® K DV Patch in the Clinical Routine
Uni-Graft® K DV Patch is marketed in Europe since 1999 for reconstructive interventions of the deep femoral, femoral and iliac artery and was also indicated for carotid interventions until 01/2020.
- Conditions
- Femoral Artery Stenosis, Iliac Artery Stenosis, Carotid Artery Stenosis
- Trial name
- RESTUGPA (NCT05117515)
- Testing
- Vascular reconstruction
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
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
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
A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW
To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal…
- Trial name
- NCT02965677
- Testing
- Paclitaxel Releasing Peripheral Balloon Dilatation Catheter, Peripheral Balloon Dilatation Catheter
- Where
- 13 sites in China
- Volunteers
- 172 people
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
Superficial Femoral Artery Stenosis, Popliteal Artery Stenosis
First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease
This is a prospective, open label, multicenter, single arm, first in human clinical study. Patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled.
- Trial name
- CHAMPIONSHIP (NCT06410313)
- Testing
- ChampioNIR Ridaforolimus Eluting Peripheral Stent System
- Where
- 7 sites in United States, Australia
- Volunteers
- 30 people
- Sponsor
- Medinol Ltd.
Superficial Femoral Artery Stenosis, Iliac Artery Stenosis
Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease
The purpose of this study is to evaluate long-term safety and performance per the intended use of the S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL™ Nitinol Stent System (SMART CONTROL) and S.M.A.R.T.™…
- Conditions
- Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Popliteal Artery Stenosis
- Trial name
- REAL-SMART (NCT07338890)
- Testing
- S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL ™ Nitinol Stent System, S.M.A.R.T.™ Flex Vascular Stent System
- Where
- Spain
- Volunteers
- 240 people
- Sponsor
- Cordis US Corp.
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
SELUTION4SFA Trial
This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA)…
- Trial name
- NCT05132361
- Testing
- SELUTION SLR™ 018 DEB, Plain (Uncoated) Balloon Angioplasty (PTA)
- Where
- 38 sites in United States, Austria and 2 more
- Volunteers
- 300 people
- Sponsor
- M.A. Med Alliance S.A.
Peripheral Arterial Disease
Multi-center Study for Stent Graft System for Peripheral Artery
The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease.
- Trial name
- VJH11-01 (NCT01575808)
- Testing
- GP1101
- Where
- 15 sites in Japan
- Volunteers
- 133 people
- Sponsor
- W.L.Gore & Associates
Peripheral Artery Disease
Safety/ Feasibility of Percutaneous Administration of Vonapanitase as Monotherapy for Peripheral Artery Disease (PAD) of the SFA and Popliteal Arteries
The research study is designed to assess the technical feasibility and safety of percutaneous administration of vonapanitase to the superficial femoral or popliteal artery in patients with PAD.
- Trial name
- NCT02953496
- Testing
- vonapanitase
- Where
- United States
- Sponsor
- Proteon Therapeutics
Superficial Femoral Artery Stenosis
CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")
The objectives of this study are to collect post-market confirmatory evidence of the safety and effectiveness of the Bard® LifeStent® Vascular Stent System and LifeStent® XL Vascular Stent System (together the "LifeStent®…
- Trial name
- CONTINUUM (NCT00908947)
- Testing
- PTA followed by placement of LifeStent® Vascular Stent
- Where
- 29 sites in United States
- Volunteers
- 173 people
- Sponsor
- C. R. Bard
Femoral Artery Stenosis, Popliteal Artery Stenosis
Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)
The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery.
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- CONFIRM (NCT02813577)
- Testing
- Lutonix® 035 Drug Coated Balloon PTA Catheter
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- C. R. Bard
Femoral Artery Stenosis, Femoral Artery Occlusion
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Restenosis
- Trial name
- SFA ISR (NCT02063672)
- Testing
- Lutonix DCB, Standard Uncoated Balloon Angioplasty Catheter
- Where
- 20 sites in United States
- Volunteers
- 82 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion
Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion
- Trial name
- NCT03121430
- Testing
- Drug eluting peripheral vascular stent system, Nitinol Stent System
- Where
- China
- Volunteers
- 138 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Peripheral Artery Disease, De Novo Stenosis
Compare the Effectiveness and Safety of Genoss® DCB and IN.PACT Admiral® DCB in Patients With Peripheral Artery Disease
The purpose of this clinical trial is to demonstrate the non-inferiority of GENOSS DCB versus IN.PACT Admiral DCB on late lumen loss 6 months after the procedure in patients with de novo or non-stented restenotic lesions of the…
- Trial name
- NCT05134545
- Testing
- Genoss® DCB, IN.PACT Admiral® DCB
- Where
- South Korea
- Volunteers
- 119 people
- Sponsor
- Genoss Co., Ltd.
Popliteal Artery Disease, Superficial Femoral Artery Disease
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Percutaneous Transluminal Angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries.
- Trial name
- MAGICAL SFA (NCT07359807)
- Testing
- Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter, Paclitaxel drug-coated balloon angioplasty
- Volunteers
- 478 people
- Sponsor
- Concept Medical Inc.
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 Arterial Disease, Iliac Artery Stenosis
Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion
- Conditions
- Peripheral Arterial Disease, Iliac Artery Stenosis, Femoral Artery Stenosis, Popliteal Artery Stenosis
- Trial name
- NCT03844724
- Testing
- ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter, Peripheral Balloon Dilatation Catheter
- Volunteers
- 204 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Superficial Femoral Artery Stenosis, Atherosclerosis of Femoral Artery
Efficacy of the EPIC Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) Lesions
This is a national, prospective, multi-center, non-randomized study to evaluate the long-term efficacy and integrity of the EPICTM Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) lesions.
- Trial name
- EPIC SFA BR (NCT01327950)
- Where
- 6 sites in Brazil
- Volunteers
- 86 people
- Sponsor
- Endovascular Consultoria Limitada
Iliac Artery Stenosis, Iliac Artery Occlusion
Safety and Efficacy Study of GoldenFlow Peripheral Stent System
A Prospective, Multi-center, Single-Arm Clinical Trial to evaluate the safety and efficacy of the GodenFlow Peripheral Stent System manufactured by Lifetech Scientific (Shenzhen) Co., LTD.
- Conditions
- Iliac Artery Stenosis, Iliac Artery Occlusion, Femoral Artery Stenosis, Femoral Artery Occlusion
- Trial name
- NCT03687983
- Testing
- GoldenFlow Peripheral Stent System
- Where
- 12 sites in China
- Volunteers
- 90 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.