Clinical trials: Lower Extremity Artery Disease
Peripheral Artery Disease
Leg Thermotherapy for Intermittent Claudication
This study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological intervention that could improve the mobility and exercise tolerance of patients with intermittent claudication.
- Trial name
- NCT02770547
- Testing
- Low Heat Thermotherapy, High Heat Thermotherapy
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Indiana University
Peripheral Arterial Disease
Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease
The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the treatment of patients with lower extremity vascular disease with chronic total occlusions.
- Trial name
- NCT02653456
- Testing
- RA-308 Excimer Laser and DABRA Catheter
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Ra Medical Systems
Peripheral Artery Disease
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the…
- Trial name
- VOYAGER PAD (NCT02504216)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 532 sites in United States, Argentina and 32 more
- Volunteers
- 6,564 people
- Sponsor
- Bayer
Intermittent Claudication, Peripheral Vascular Disease
Adjuvant Benefit of NMES to Supervised Exercise in Patients With IC
This study will assess the adjuvant benefit of a neuromuscular electrical stimulation device to standard treatment of supervised exercise in patients suffering from symptoms and effects of lower limb Intermittent Claudication.
- Conditions
- Intermittent Claudication, Peripheral Vascular Disease, Lower Limb Arterial Disease
- Trial name
- AdjIC (NCT02429310)
- Testing
- Revitive IX
- Where
- United Kingdom
- Volunteers
- 42 people
- Sponsor
- Imperial College London
Peripheral Arterial Disease, Claudication
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.
- Conditions
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT00883246
- Testing
- SilverHawk & TurboHawk Peripheral Plaque Excision System
- Volunteers
- 800 people
- Sponsor
- Medtronic Endovascular
Amputation, Diabetes Mellitus
Dysvascular Amputation Self-Management of Health
The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.
- Conditions
- Amputation, Diabetes Mellitus, Peripheral Artery Disease
- Trial name
- DASH (NCT04083456)
- Testing
- Walking Biobehavioral Intervention, Attention Control
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Colorado, Denver
Peripheral Artery Disease
Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization
To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease.
- Trial name
- REVEAL (NCT02961894)
- Testing
- Revolution™ Peripheral Atherectomy System
- Where
- 17 sites in United States
- Volunteers
- 121 people
- Sponsor
- Rex Medical
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 Artery Disease
Optical Imaging Measurement of Intravascular Solution Efficacy Trial
Iodinated contrast is the current gold standard for infrainguinal angiography imaging in patients without renal insufficiency and has also been used with intravascular Optical Coherence Tomography (iOCT) to improve image quality…
- Trial name
- OPTIMISE (NCT01743872)
- Testing
- Contrast Injection, Dextran Injection, CO2 Injection
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Peripheral Arterial Disease (PAD)
Evaluation of WIRION™ EPS in Lower Extremities Arteries
Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)
- Trial name
- WISE-LE (NCT02780349)
- Testing
- WIRION
- Where
- 10 sites in United States, Germany
- Volunteers
- 103 people
- Sponsor
- Gardia Medical
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
Type 2 Diabetes, Peripheral Arterial Disease
Liraglutide and Peripheral Artery Disease
STARDUST is an open-label, two-arm randomized controlled trial, aimed at evaluating the effects of liraglutide on peripheral perfusion, as compared with the aggressive treatment of cardio-metabolic risk factors, in people with…
- Trial name
- STARDUST (NCT04881110)
- Testing
- Liraglutide, Control
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- University of Campania Luigi Vanvitelli
Peripheral Arterial Disease
Evaluation of the GORE TIGRIS Vascular Stent
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial…
- Trial name
- TIGRIS (NCT01576055)
- Testing
- TIGRIS Vascular Stent, BARD LifeStent
- Where
- 34 sites in United States
- Volunteers
- 267 people
- Sponsor
- W.L.Gore & Associates
Atherosclerosis of Native Arteries of the Extremities
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project
To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
- Trial name
- MAJESTIC (NCT01820637)
- Testing
- The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
- Where
- 13 sites in Australia, Austria and 3 more
- Volunteers
- 57 people
- Sponsor
- Boston Scientific Corporation
Diabetes
Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging
Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse…
- Trial name
- NCT00770679
- Testing
- lipitor
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Johns Hopkins University
Peripheral Arterial Disease
A Study of Loco-Regional Liposomal Bupivacaine Injection
The purpose of this research is to find out if using liposomal bupivacaine solution (bupivacaine liposome) injections during lower extremity revascularization surgery will lower the amount of narcotic drugs used during and…
- Trial name
- NCT05992896
- Testing
- Bupivacaine liposome
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Mayo Clinic
Diabetes Mellitus, Critical Limb Ischemia
N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes
In this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial for 30 days for participants with critical limb ischemia (CLI) who undergo a major…
- Conditions
- Diabetes Mellitus, Critical Limb Ischemia, Lower Limb Amputation Knee, Peripheral Arterial Disease
- Trial name
- NCT03253328
- Testing
- Active Arm N-acetyl cysteine (NAC)
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Washington University School of Medicine
Peripheral Arterial Disease
Endothelial Function in Lower Extremity Bypass Grafts
This study will determine whether or not saphenous vein [arterial] bypass grafts in the leg relax in response to increases in blood flow.
- Trial name
- NCT00759707
- Testing
- L-N^G monomethyl arginine (L-NMMA)
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Brigham and Women's Hospital
Diabetic Foot, Peripheral Arterial Disease
TEsting for Arterial Disease in Diabetes (TrEAD) Study
This study will focus on determining; How accurate the test is in detecting poor circulation How it's accuracy compares to other commonly used tests, and Whether test results are linked to the chance of ulcer healing or…
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases
- Trial name
- NCT04058626
- Testing
- Transcutaneous pressure of oxygen (TcPO2), Toe Brachial Pressure Index (TBPI), Podiatry Ankle Duplex scan (PAD-scan)
- Where
- 2 sites in United Kingdom
- Volunteers
- 305 people
- Sponsor
- Imperial College Healthcare NHS Trust
Diabetic Foot, Peripheral Arterial Disease
Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
In the UK there are over 7,000 leg amputations each year because of diabetes. The most important cause of this is poor circulation. The detection of poor circulation in patients with diabetes is difficult.
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases
- Trial name
- DM PAD (NCT05009602)
- Testing
- Toe Brachial Pressure Index (TBPI), Ankle Brachial Pressure Index (ABPI), Exercise Ankle Brachial Pressure Index (ABPI)
- Where
- 17 sites in United Kingdom
- Volunteers
- 604 people
- Sponsor
- Imperial College London