Clinical trials: Atherosclerosis of Femoral Artery
Peripheral Artery Disease
Pilot Study of PRT-201 Following Angioplasty in Patients With Peripheral Artery Disease (PAD)
The purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the adventitia of arteries following successful angioplasty (PTA).
- Trial name
- NCT01616290
- Testing
- PRT-201
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Proteon Therapeutics
Peripheral Artery Disease
Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:
To describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or restenotic lesion(s), occluded/stenotic or…
- Trial name
- PK (NCT01912937)
- Testing
- Angioplasty treatment with the CVI Drug-coated Balloon (DCB)
- Where
- 2 sites in New Zealand
- Volunteers
- 25 people
- Sponsor
- Spectranetics Corporation
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
Myocardial Infarction, Stroke
Women's Health Initiative Strong and Healthy Study
The WHISH trial applies state-of-the science behavioral principles and currently available technologies to deliver a physical activity intervention without face-to-face contact to ~25,000 older U.S. women expected to consent.
- Conditions
- Myocardial Infarction, Stroke, Cardiovascular Mortality, Hip Fractures
- Trial name
- WHISH (NCT02425345)
- Testing
- Physical Activity
- Volunteers
- 49,331 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
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
Peripheral Arterial Disease
BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery
Prospective, multi-center 1:1 randomized trial to compare efficacy and safety of a stent-avoiding (using drug coated balloons) versus a stent-preferred (using drug eluting or interwoven stents) approach for treatment of complex…
- Trial name
- NCT03776799
- Testing
- Stent-avoiding, Stent-based
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- University of Leipzig
Peripheral Arterial Disease
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points.
- Trial name
- FREEDOM OP (NCT03185052)
- Testing
- Manual puncture point compression
- Where
- 10 sites in France
- Volunteers
- 116 people
- Sponsor
- Nantes University Hospital
Peripheral Artery Disease, Peripheral Vascular Disease
Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native…
- Trial name
- BIOFLEX-I (NCT01319812)
- Testing
- Astron Stents, Pulsar Stents
- Where
- 35 sites in United States, Canada
- Volunteers
- 463 people
- Sponsor
- Biotronik, Inc.
Brachial Access, Access Complication
Evaluation of Shoulder Access Safety Using the NewMan Compression Device
The aim of the study is to evaluate the effectiveness of the NewMan compression device in shoulder access in patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries by comparing the…
- Conditions
- Brachial Access, Access Complication, Hemostasis Compression Device, Atherosclerosis of the Arteries of the Lower Extremities
- Trial name
- SAND (NCT07714824)
- Testing
- Hemostasis is performed using a pressure bandage, Hemostasis is performed using the NewMan compression device
- Where
- Russia
- Volunteers
- 229 people
- Sponsor
- Pirogov Russian National Research Medical University
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 Vascular Disease, Coronary Artery Disease
Angio-Seal Evolution Device Registry
Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional patient populations.
- Conditions
- Peripheral Vascular Disease, Coronary Artery Disease, Peripheral Artery Disease, Arterial Occlusive Disease
- Trial name
- NCT00817349
- Where
- 10 sites in United States
- Volunteers
- 1,004 people
- Sponsor
- Abbott Medical Devices
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.
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
FREEDOM: "Pilot Study of the Feasibility and Safety of Resuming Early Walking After Manual Compression in Patients Treated for Peripheral Artery Disease by Endovascular Technique Involving Retrograde Femoral Puncture"
Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points.
- Trial name
- FREEDOM (NCT02198612)
- Testing
- Manual puncture point compression
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Nantes University Hospital
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
Atherosclerosis, Stent Complication
Fatigue Behavior of Peripheral STENt of the Superficial Femoral Artery
Endovascular treatment of superficial femoral artery stenosis/obstruction is still the subject of debate in the scientific literature.
- Trial name
- FASTEN-PRO (NCT06198920)
- Testing
- Stenting of the superficial femoral artery
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- IRCCS Policlinico S. Donato
Peripheral Arterial Disease
Remedy, Biodegradable Peripheral Stent Registry
This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries.
- Trial name
- NCT01420120
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- be Medical
Peripheral Artery Disease, Femoropopliteal Stenosis
Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence
The femoropopliteal artery segment (FPAS) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements.
- Trial name
- CTPred (NCT06260488)
- Testing
- Endovascular surgery
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Strasbourg, France
Peripheral Arterial Disease, Intermittent Claudication
Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System
An evaluation of the safety and performance of the STANZA Drug-eluting Resorbable Scaffold (DRS) system for the treatment of patients with obstructive superficial femoral artery disease.
- Conditions
- Peripheral Arterial Disease, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases
- Trial name
- SPRINT (NCT02097082)
- Testing
- STANZA Drug-eluting resorbable Scaffold
- Where
- 9 sites in Austria, Germany and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- 480 Biomedical