Clinical trials: Superficial Femoral Artery Disease
Peripheral Arterial Disease, Claudication
ILLUMENATE EU Randomized Clinical Trial
This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the…
- Trial name
- EU RCT (NCT01858363)
- Testing
- CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter, Bare Percutaneous Transluminal Angioplasty Balloon Catheter
- Where
- Germany
- Volunteers
- 294 people
- Sponsor
- Spectranetics 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.
Peripheral Vascular Disease
A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery
OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects will undergo a superficial femoral artery (SFA) stent procedure using the Misago™ Peripheral Self Expanding stent once all of the…
- Trial name
- OSPREY (NCT01118117)
- Testing
- Misago™ Self-Expanding Stent System
- Where
- 31 sites in United States
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Terumo Medical Corporation
Peripheral Artery Disease
Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified…
- Trial name
- KAIZEN (NCT05529472)
- Testing
- Peripheral Orbital Atherectomy System (OAS)
- Where
- 12 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Abbott Medical Devices
Atherosclerosis of Native Arteries of the Extremities
ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent
The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA)…
- Trial name
- IMPERIAL (NCT02574481)
- Testing
- ELUVIA (Stent Implantation), Zilver PTX (Stent Implantation)
- Where
- 68 sites in United States, Austria and 5 more
- Volunteers
- 524 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease
The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study
The primary objective of the TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA or the superficial…
- Trial name
- TORUS2 (NCT04130737)
- Testing
- TORUS Stent Graft System
- Where
- 32 sites in United States
- Volunteers
- 188 people
- Sponsor
- Endologix
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 Arterial Disease
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in…
- Trial name
- ILLUMENATE (NCT01927068)
- Testing
- Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)
- Where
- 44 sites in Australia, Austria and 8 more
- Volunteers
- 499 people
- Sponsor
- Spectranetics Corporation
Restenosis, Peripheral Vascular Disease
JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone.
- Trial name
- JetStreamISR (NCT01722877)
- Testing
- JetStream Navitus
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Midwest Cardiovascular Research Foundation
Peripheral Arterial Disease
Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon
This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.
- Trial name
- ILLUMENATE (NCT01858428)
- Testing
- Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter, EverCross Percutaneous Transluminal Balloon Catheter
- Where
- 44 sites in United States, Austria
- Volunteers
- 300 people
- Sponsor
- Spectranetics Corporation
Vascular Disease, Peripheral
Prevention of Restenosis Following Revascularization
The purpose of this study is to investigate the prevention of Restenosis following Revascularization of the superficial Femoral Artery (SFA)
- Trial name
- NCT00518284
- Testing
- Nanoparticle Paclitaxel
- Where
- 7 sites in United States
- Volunteers
- 6 people
- Sponsor
- Celgene 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
Peripheral Artery Disease, Atherosclerosis
RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty
To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA).
- Conditions
- Peripheral Artery Disease, Atherosclerosis, Artery Diseases, Peripheral, Plaque, Atherosclerotic
- Trial name
- RANGER II SFA (NCT03064126)
- Testing
- RANGER™ Paclitaxel Coated Balloon, Paclitaxel, Standard Balloon Angioplasty
- Where
- 67 sites in United States, Austria and 4 more
- Volunteers
- 440 people
- Sponsor
- Boston Scientific Corporation
Peripheral Artery Disease
Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH)
The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic cellular therapy, delivered as a single injection following percutaneous transluminal ("balloon") angioplasty and stent placement for…
- Trial name
- TRIUMPH (NCT01099215)
- Testing
- PVS-10200
- Where
- 3 sites in France
- Volunteers
- 21 people
- Sponsor
- Shire
Peripheral Arterial Disease
Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™ plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in treatment of moderate to severely calcified…
- Trial name
- NCT00733135
- Testing
- SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device
- Volunteers
- 133 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease, Peripheral Vascular Diseases
Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter
The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases
- Trial name
- SAFE-DCB (NCT02424383)
- Testing
- PTA (Lutonix® 035 DCB Catheter)
- Where
- 73 sites in United States
- Volunteers
- 1,005 people
- Sponsor
- C. R. Bard
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 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, 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