Clinical trials: Atherosclerosis of Femoral Artery
Peripheral Artery Disease, Atherectomy in Diseased Lower Extremity Arteries
Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Embolic Protection for Superficial Femoral Artery Occlusions
Peripheral artery disease can reduce blood flow to the legs. In some patients, the superficial femoral artery, a major artery in the thigh, is completely blocked over a long segment.
- Trial name
- NCT07803718
- Testing
- Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Sakarya University
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
Arterial Occlusive Diseases, Vascular Diseases
Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery
Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass.
- Trial name
- SPACIAL (NCT01147419)
- Testing
- stent, femoral-popliteal bypass with artificial blood vessel
- Where
- 3 sites in China
- Volunteers
- 200 people
- Sponsor
- Peking Union Medical College Hospital
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 Arterial Disease
The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow
The aim of this study was to investigate the effect of one session OMT on arterial circulation in patients with PAD.
- Trial name
- NCT03928860
- Testing
- OMT session
- Where
- Turkey (Türkiye)
- Volunteers
- 15 people
- Sponsor
- Kırıkkale University
Peripheral Artery Disease (PAD)
Use of Three-Dimensional Printed Models for Endovascular Planning and Follow-up in Patients Affected by Aorto-Iliac-Femoral-Popliteal Arterial Disease Undergoing Balloon Angioplasty. A Single-center, Single-blind Randomized Controlled Trial
Lower extremity peripheral arterial disease is a major health problem. Currently, balloon angioplasty represents the most commonly performed treatment for patients affected by vascular claudication or critical limb ischemia.
- Trial name
- 3DPAD-1 (NCT07000097)
- Testing
- PTA planning supported by 3D-printed model, PTA (Standard of Care)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Azienda Ospedaliero-Universitaria di Parma
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
Obstructive Disease, Atherosclerosis of Femoral Artery
IN.PACT™ Quality of Life Post-Reimbursement Study
To prospectively collect and assess the perception of health-related Quality of Life, Pain and Walking Ability.
- Conditions
- Obstructive Disease, Atherosclerosis of Femoral Artery, Atherosclerosis of Popliteal Artery
- Trial name
- NCT04597307
- Testing
- IN.PACT™ Admiral™ Drug Coated Balloon (DCB)
- Where
- 9 sites in France
- Volunteers
- 80 people
- Sponsor
- Medtronic
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 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
Atherosclerosis, Ischemia Limb
Efficacy and Safety Comparison of the Endovascular and the Hybrid Methods for the Treatment of Prolonged Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D
A recent study, where the authors studied the effectiveness of stenting of prolonged lesions (>200 mm) of the femoral-popliteal segment with nitinol stents (TASC II, D), showed unsatisfactory primary patency rates (45%) within 2…
- Conditions
- Atherosclerosis, Ischemia Limb, Superficial Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- NCT04590131
- Testing
- recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal., recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Dyslipidemia, Atherosclerosis
Effects of Nicotinic Acid Plus Simvastatin Versus Simvastatin Alone on Carotid and Femoral Intima-Media Thickness in Patients With Peripheral Artery Disease (NASCIT)
Dyslipidaemia is characterized by low plasma levels of high-density lipoprotein cholesterol (HDL-c), elevated triglycerides and an increase in low density lipoprotein (LDL-c) particles, and has been unequivocally established as a…
- Trial name
- NASCIT (NCT00712049)
- Testing
- simvastatin, Nicotinic Acid
- Where
- Austria
- Volunteers
- 200 people
- Sponsor
- Medical University of Vienna
Atherosclerosis, Ischemia
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of…
- Trial name
- NCT05158257
- Testing
- balloon and Stent, endovascular debulking and DCB
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Xuanwu Hospital, Beijing
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, Peripheral Artery Disease
Blood Flow Changes in Femoral-popliteal Bypass Grafts After Neuromuscular Electrical Stimulation (NMES).
The muscles of the leg require a regular supply of oxygen and nutrients. This is supplied by blood carried by a network of large blood vessels known as arteries.
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Peripheral Vascular Disease, Femoral Popliteal Occlusion
- Trial name
- HAEMUS (NCT04109287)
- Testing
- REVITIVE® device
- Where
- United Kingdom
- Sponsor
- Imperial College Healthcare NHS Trust