Clinical trials: Atherosclerosis of Femoral Artery
Peripheral Artery Disease
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A…
- Trial name
- TOBA II (NCT02522884)
- Testing
- Tack Endovascular System
- Where
- 39 sites in United States, Austria and 1 more
- Volunteers
- 213 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Peripheral Artery Disease, Peripheral Vascular Disease
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery.
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Vascular Disease, Cardiovascular Diseases
- Trial name
- OPEN (NCT01355406)
- Testing
- FlexStent® Femoropopliteal Self Expanding Stent System
- Where
- 38 sites in United States, Belgium
- Volunteers
- 257 people
- Sponsor
- Cordis US Corp.
Peripheral Artery Disease
Prospective Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral And/or Popliteal Arteries Using the FLEX Scoring Catheter Plus DCB
Prospective, single-center, single-arm, non-randomized study to assess the safety and efficacy of the FLEX Scoring Catheter in patients with atherosclerotic peripheral artery disease in the superficial femoral and popliteal…
- Trial name
- FORTEZ (NCT03676842)
- Testing
- FLEX Dynamic Scoring Catheter with IN.PACT Admiral DCB
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- VentureMed Group Inc.
Arterial Occlusive Diseases, Atherosclerosis
A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries
The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions…
- Conditions
- Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis
- Trial name
- REGAL (NCT03037411)
- Testing
- Peripheral stenting
- Where
- 23 sites in Austria, Belgium and 3 more
- Volunteers
- 291 people
- Sponsor
- Boston Scientific Corporation
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
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
- 34 sites in United States, Austria and 2 more
- Volunteers
- 300 people
- Sponsor
- M.A. Med Alliance S.A.
Peripheral Vascular Diseases, Claudication
Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis
This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery…
- Trial name
- DURABILITY II (NCT00530712)
- Testing
- PROTÉGÉ® EverFlex™ Self-Expanding Stent System
- Volunteers
- 287 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease
To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease
A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.
- Trial name
- NCT05662618
- Testing
- Percutaneous selective arteriography of peripheral arteries
- Where
- China
- Volunteers
- 276 people
- Sponsor
- Shanghai Bomaian Medical Technology Co., Ltd
Peripheral Arterial Disease
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)
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
- NCT02733653
- Testing
- Jetstream Atherectomy System
- Where
- 10 sites in Japan
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
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
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
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.
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 Artery Disease, Access Site Complication
BIOTRONIK 4French for AMBulatory Peripheral Intervention
BIOTRONIK 4French for AMBulatory peripheral intervention. A multicenter, controlled trial comparing 4French versus 6French femoral access for endovascular treatment of lower-extremity peripheral artery disease in an ambulatory…
- Conditions
- Peripheral Artery Disease, Access Site Complication, Outpatient Treatment
- Trial name
- BIO4AMB (NCT03044002)
- Testing
- Biotronik 4 French Portfolio, 6 French Portfolio
- Where
- 5 sites in Austria, Belgium and 2 more
- Volunteers
- 821 people
- Sponsor
- Biotronik AG
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
Peripheral Arterial Disease, Lower Extremity Arterial Disease
EverFlex Post Approval Study
This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal…
- Trial name
- DURABILITY PAS (NCT01680835)
- Testing
- EverFlex™ Self-Expanding Peripheral Stent System
- Where
- 23 sites in United States
- Volunteers
- 108 people
- Sponsor
- Medtronic Endovascular
Peripheral Vascular Disease, Femoral Occlusive Disease
New Anastomotic Device for End to End Vascular Anastomosis in the Treatment of Peripheral Vascular Disease
The medical device "Vascular Join" represents a new anastomotic technology that should reduce the inter-surgeons variability in anastomosis construction and increase the performances in terms of results.
- Conditions
- Peripheral Vascular Disease, Femoral Occlusive Disease, Femoropopliteal Occlusive Disease, Aortoiliac Atherosclerosis
- Trial name
- VJ (NCT01514916)
- Testing
- mechanical anastomosis without suture
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Ab Medica Spa
Peripheral Arterial Disease
Tack Optimized Drug Coated Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries
This is an Outside the United States, post-CE Mark, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System.
- Trial name
- TOBA III (NCT02802306)
- Testing
- Tack Endovascular System
- Where
- 17 sites in Austria, Belgium and 2 more
- Volunteers
- 201 people
- Sponsor
- Philips Clinical & Medical Affairs Global
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
Peripheral Arterial Disease
Chronic Total Occlusion Crossing With the Wildcat Catheter
This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a single femoropopliteal chronic total occlusion (CTO).
- Trial name
- CONNECT (NCT01174784)
- Testing
- Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer
- Where
- 15 sites in United States
- Volunteers
- 88 people
- Sponsor
- Avinger, Inc.