Clinical trials: Critical Ischemia Limb
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive…
- Trial name
- NCT03124875
- Testing
- LimFlow System
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- LimFlow, Inc.
Cardiovascular Disease, Peripheral Artery Disease
Platelet Activity in Vascular Surgery and Cardiovascular Events
Pathological and clinical studies have consistently demonstrated that abnormalities in thrombosis and hemostasis play a major role in the pathogenesis of atherosclerosis and atherothrombosis.
- Conditions
- Cardiovascular Disease, Peripheral Artery Disease, Critical Limb Ischemia
- Trial name
- PACE (NCT02106429)
- Where
- United States
- Volunteers
- 246 people
- Sponsor
- NYU Langone Health
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
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
Critical Limb Ischemia
Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia
Background: Up to 10% of patients with peripheral arterial disease (PAD) will develop critical limb ischemia (CLI) which is a decrease of blood flow in the arteries of the limb.
- Trial name
- RIVAL-PAD (NCT02260622)
- Testing
- rivaroxaban plus aspirin, clopidogrel plus aspirin
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Ottawa Hospital Research Institute
Peripheral Artery Disease
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia
Non-randomized, multi-center, longitudinal study of healthy subjects and subjects with PAD who are scheduled for ABI, TBI, and either Duplex Ultrasound or Angiographic assessments in a vascular clinic.
- Trial name
- NCT04120610
- Testing
- FlowMet-R, ABI, TBI
- Where
- 5 sites in United States
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- Medtronic Endovascular
Critical Limb Ischemia
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
- Trial name
- NCT01870401
- Testing
- Lutonix DCB, Uncoated PTA Catheter
- Where
- 51 sites in United States, Austria and 6 more
- Volunteers
- 442 people
- Sponsor
- C. R. Bard
Chronic Limb Threatening Ischemia
Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self-reported Quality of Life
CLTI is the most severe form of peripheral arterial disease. Patients with the condition require investigation and management (typically in the form of revascularisation surgery) to salvage the limb.
- Trial name
- NCT05613907
- Testing
- CLTI Clinic
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
Peripheral Artery Disease, Critical Limb Ischemia
Complete Lesion Assessment With ffR and IVUS TechnologY
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
- Trial name
- CLARITY I (NCT01941030)
- Testing
- Orbital Atherectomy System, Balloon Angioplasty
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia
ACP-01 in Patients With Critical Limb Ischemia
The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of…
- Trial name
- NCT02551679
- Testing
- ACP-01
- Where
- 19 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- Hemostemix
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
Critical Lower Limb Ischemia
Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia
This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels.
- Trial name
- INPACT-DEEP (NCT00941733)
- Testing
- IN.PACT Amphirion, Standard PTA
- Where
- 13 sites in Austria, Belgium and 4 more
- Volunteers
- 358 people
- Sponsor
- Medtronic Endovascular
Critical Limb Ischemia (CLI)
LIFE-BTK Randomized Controlled Trial
The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed…
- Trial name
- LIFE-BTK (NCT04227899)
- Testing
- Esprit BTK Device, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 50 sites in United States, Australia and 4 more
- Volunteers
- 261 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia, Peripheral Arterial Disease
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- MOBILE (NCT01049919)
- Testing
- Bone marrow concentration device
- Where
- 25 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Critical Limb Ischemia (CLI)
LIFE-BTK PK Sub-study
LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside…
- Trial name
- NCT05208905
- Testing
- Esprit BTK Device
- Where
- 5 sites in United States, Australia and 1 more
- Volunteers
- 9 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia
The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs.
- Trial name
- SAVAL (NCT03551496)
- Testing
- Drug Eluting Stent - Below the Knee, Standard PTA Control Arm
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 201 people
- Sponsor
- Boston Scientific Corporation
Critical Limb Ischemia
Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia
The purpose of this study is to compare the effects (positive and negative) of two different devices available to treat people with critical limb ischemia, which involves a sudden decrease in blood flow to the leg that causes a…
- Trial name
- NCT00869375
- Testing
- Endovascular peripheral intervention
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Oklahoma
Peripheral Arterial Disease
Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD)
This study is evaluating whether a therapeutic ultrasound device can improve symptoms in the leg of peripheral arterial disease (PAD) patients 65 years of age and over.
- Trial name
- Waltz (NCT05888740)
- Testing
- VibratoSleeve Therapeutic Ultrasound Device
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Vibrato Medical, Inc.
Arterial Occlusive Disease, Peripheral Vascular Disease
Study of Hepatocyte Growth Factor (HGF) Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia Patients With Peripheral Ischemic Ulcers
The objective of this study is to test the hypothesis that AMG0001 treatment is safe and induces angiogenesis as detected by improved wound healing, reduction in amputation, improved pain at rest and hemodynamic measurement and…
- Conditions
- Arterial Occlusive Disease, Peripheral Vascular Disease, Ischemia, Ulcers
- Trial name
- NCT00189540
- Testing
- HGF plasmid
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- AnGes USA, Inc.
Peripheral Arterial Occlusive Disease
Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
The study is to confirmatorily show a superior effect of Alprostadil compared to placebo on the rate of complete healing of ischemic necroses and ulcerations as well as on the frequency and height of major amputations in patients…
- Trial name
- ESPECIAL (NCT00596752)
- Testing
- Alprostadil
- Where
- 78 sites in Czechia, Germany and 4 more
- Volunteers
- 840 people
- Sponsor
- UCB BIOSCIENCES GmbH