Clinical trials: Superficial Femoral Artery Occlusion
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 Artery Disease
Prospective, Post Market Surveillance Q3-registry (POLARIS)
This is a prospective, non-randomized post market surveillance registry designed to document the clinical Performance in Routine clinical practice of the POLARIS Peripheral Vascular Self Expanding Stent System
- Trial name
- Q3-Registry (NCT02307292)
- Testing
- POLARIS Peripheral Vascular Self Expanding Stent System
- Where
- Germany
- Volunteers
- 250 people
- Sponsor
- QualiMed Innovative Medizinprodukte GmbH
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.
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
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
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
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
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
Peripheral Arterial Disease
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the…
- Trial name
- Axys ACHIEVE (NCT04282161)
- Testing
- Axys EX device
- Sponsor
- Medtronic Endovascular
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 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 Disease, Peripheral Vascular Diseases
Natural Vascular Scaffold (NVS) Therapy
The NVS Therapy is being studied to evaluate the safety and efficacy of retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arteries with reference vessel diameters…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Catheterization, Peripheral
- Trial name
- NCT03148808
- Testing
- NVS Therapy
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Alucent Biomedical
Atherosclerosis of Native Arteries of the Extremities, Unspecified
SuperNOVA Clinical Stenting Trial
The primary objective of this clinical study is to determine whether the Innova Stent System shows acceptable performance in long-term (12-month) safety rates and vessel patency when treating femoropopliteal lesions.
- Trial name
- NCT01292928
- Testing
- Stent implantation
- Where
- 49 sites in United States, Austria and 5 more
- Volunteers
- 299 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease
IN.PACT Global Clinical Study
The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world"…
- Trial name
- NCT01609296
- Testing
- IN.PACT Admiral™ Drug Eluting Balloon
- Where
- 65 sites in Argentina, Australia and 25 more
- Volunteers
- 1,535 people
- Sponsor
- Medtronic Endovascular
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
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
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 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
BEnefit of Arterial Preparation by LONGitudinal Scoring
The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery ("scoring") and therefore promote a regular expansion of atheroma by balloon inflation.
- Trial name
- BELONG (NCT03721939)
- Testing
- FLEX Scoring Catheter
- Where
- Switzerland
- Volunteers
- 150 people
- Sponsor
- VentureMed Group Inc.
Peripheral Arterial Disease, Peripheral Vascular Diseases
Natural Vascular Scaffold (NVS) Therapy for Treatment of Atherosclerotic Lesions (Activate I)
The NVS Therapy is being studied to evaluate the safety and efficacy to facilitate retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arteries with reference vessel…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Catheterization, Peripheral
- Trial name
- NCT04188262
- Testing
- NVS Therapy
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Alucent Biomedical