Clinical trials: Femoral Artery Occlusion
Peripheral Arterial Disease
Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent in the Superficial Femoral Artery
This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions.
- Trial name
- BOSS (NCT01499342)
- Where
- 2 sites in Belgium
- Volunteers
- 435 people
- Sponsor
- be Medical
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
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
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
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 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.
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, 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
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
CVI Drug Coated Balloon First In Human Trial
The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or…
- Trial name
- NCT02110524
- Testing
- Percutaneous Transluminal Angioplasty
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Spectranetics Corporation
Femoral Artery Stenosis, Femoral Artery Occlusion
Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech Scientific (Shenzhen) Co., LTD.
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Popliteal Arterial Stenosis, Popliteal Artery Occlusion
- Trial name
- NCT03683459
- Testing
- FemFlow Drug-Eluting Peripheral Balloon Catheter
- Where
- 18 sites in China
- Volunteers
- 208 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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
Peripheral Vascular Diseases
Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
The purpose of this study is to confirm the safety and performance of the 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral Artery.
- Trial name
- NCT01263665
- Testing
- 25 cm GORE® VIABAHN®
- Volunteers
- 71 people
- Sponsor
- W.L.Gore & Associates
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, 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.
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
Peripheral Arterial Disease, Peripheral Arterial Disease(PAD)
Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)
The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.
- Trial name
- NCT06758921
- Testing
- Oscar Peripheral Multifunctional Catheter
- Where
- 16 sites in Austria, Belgium and 6 more
- Volunteers
- 200 people
- Sponsor
- Biotronik AG
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, 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
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