Clinical trials: Femoral Artery Occlusion
Popliteal Artery Stenosis Above the Knee, Peripheral Artery Disease
STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treating Atherosclerotic Femoro-Popliteal Lesions
The primary objective of the study is to evaluate the performance and the safety of the PAK® DCB Catheter in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and/or popliteal arteries…
- Conditions
- Popliteal Artery Stenosis Above the Knee, Peripheral Artery Disease, Superficial Femoral Artery Stenosis
- Trial name
- STAR-PAK (NCT06734221)
- Testing
- Paclitaxel Coated Peripheral Angioplasty Balloon Catheter
- Where
- 3 sites in Poland, Spain
- Volunteers
- 120 people
- Sponsor
- Balton Sp.zo.o.
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 Arterial Disease (PAD)
Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal…
- Trial name
- UltraFuture I (NCT05498740)
- Testing
- Drug eluting Balloon
- Where
- 24 sites in China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Superficial Femoral Artery Lesions, Atherosclerosis of Femoral Artery
480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions
This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the treatment of subjects with de novo native superficial femoral artery lesions.
- Trial name
- STANCE (NCT01403077)
- Testing
- 480 Biomedical Bioresorbable Scaffold System
- Where
- 6 sites in Australia, Austria and 2 more
- Volunteers
- 46 people
- Sponsor
- 480 Biomedical
Femoral Artery Stenosis, Popliteal Artery Stenosis
Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries
The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal angioplasty (PTA) catheter for treatment of…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- LEVANT 2 (NCT01412541)
- Testing
- Standard Uncoated Angioplasty Balloon, Moxy Drug Coated Balloon
- Where
- 54 sites in United States, Austria and 2 more
- Volunteers
- 532 people
- Sponsor
- C. R. Bard
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 Arterial Diseases
EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study
The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.
- Trial name
- NCT02066740
- Testing
- EverFlex™ stent with Entrust™ delivery system
- Where
- Germany
- Volunteers
- 34 people
- Sponsor
- Medtronic Endovascular
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
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
- 15 sites in United States
- Volunteers
- 410 people
- Sponsor
- Cook Research Incorporated
Atherosclerosis, Peripheral Vascular Disease
ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System
The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common…
- Conditions
- Atherosclerosis, Peripheral Vascular Disease, Claudication
- Trial name
- NCT01468974
- Testing
- ESPRIT BVS
- Where
- 8 sites in Austria, Belgium and 2 more
- Volunteers
- 35 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease, Arterial Puncture
The Safety and Efficacy of the Suture-Mediated Closure System
This was a prospective, multicenter, randomized, controlled, non-inferiority clinical study with the primary objective of validating the safety and efficacy of the Suture-Mediated Closure System for percutaneous closure of the…
- Trial name
- NCT05841836
- Testing
- the Suture-Mediated Closure System, Perclose ProGlide Suture-Mediated Closure System
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Peripheral Arterial Disease
Zilver® PTX® V Clinical Study
The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of…
- Trial name
- NCT01901289
- Testing
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Where
- 17 sites in United States
- Volunteers
- 200 people
- Sponsor
- Cook Research Incorporated
Peripheral Arterial Disease (PAD)
Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)
The purpose of this study is to compare the difference between two magnetic resonance imaging (MRI) techniques for visualizing arteries.
- Trial name
- NCT00707876
- Testing
- ferumoxytol
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Peripheral Vascular Diseases
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.
- Trial name
- VIPER (NCT00541307)
- Testing
- Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Where
- 5 sites in United States
- Volunteers
- 119 people
- Sponsor
- W.L.Gore & Associates
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 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
Femoral Artery Stenosis, Popliteal Artery Stenosis
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- INPACT SFA II (NCT01566461)
- Testing
- Drug-Coated Balloon (DCB), PTA Balloon: Balloon Angioplasty
- Where
- 2 sites in United States
- Volunteers
- 331 people
- Sponsor
- Medtronic Endovascular
Arterial Occlusive Diseases
The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent
This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C \& D superficial femoral artery long lesions (up to 22 cm) in comparison with the Bard® Luminexx™ 6F…
- Trial name
- SUPER SL (NCT00235131)
- Testing
- Smart Stent, Luminexx Stent
- Where
- 2 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Cordis US Corp.
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 Artery Disease
BRight Pharmacokinetic Study
The BRight PK Study is a prospective, single-arm, open-label, non-blinded, non-randomized study, which goal is to assess the pharmacokinetic profile of the BRight drug-coated balloon at different time points after the balloon…
- Trial name
- NCT06065345
- Testing
- BRight DCB
- Where
- Australia
- Volunteers
- 6 people
- Sponsor
- Biotronik CRC Inc.