Clinical trials: Critical Limb Ischemia
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.
Critical Limb Ischemia
Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia
The purpose of this study is to evaluate the safety and efficacy of the concentrated autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia patients.
- Trial name
- NCT01472289
- Testing
- Autologous Bone Marrow Mononuclear cells (BMMNCs)
- Where
- India
- Volunteers
- 17 people
- Sponsor
- TotipotentSC Scientific Product Pvt. Ltd.
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.
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
Critical Limb Ischemia
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
- Trial name
- NCT02046226
- Testing
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Halyard Health
Peripheral Arterial Disease
Belgian-Italian Trial to Evaluate the Efficacy and Safety of Below The Knee (BTK) Treatment With the Luminor 14 Paclitaxel Coated Percutaneous Transluminal Angioplasty Balloon Catheter of iVascular
The BIBLIOS trial investigates the efficacy and safety of BTK treatment of patients suffering from critical limb ischemia (Rutherford 5) with the Luminor-14 Paclitaxel coated Percutaneous Transluminal Angioplasty Balloon catheter…
- Trial name
- BIBLIOS (NCT03845543)
- Testing
- Luminor-14 Paclitaxel eluting balloon
- Where
- 9 sites in Belgium, Italy and 1 more
- Volunteers
- 150 people
- Sponsor
- ID3 Medical
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.
Critical Limb Ischemia, Peripheral Arterial Disease
IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA
To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the…
- Trial name
- NCT02963649
- Testing
- DCB, PTA
- Where
- 9 sites in Belgium, France and 3 more
- Volunteers
- 50 people
- Sponsor
- Medtronic Endovascular
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
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
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
Percutaneous Deep Vein Arterialization Post-Market Study
The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.
- Trial name
- PROMISE UK (NCT03807661)
- Testing
- Percutaneous deep vein arterialization, LimFlow System
- Where
- 6 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- LimFlow SA
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
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
Peripheral Arterial Disease
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter…
- Trial name
- TOBA II BTK (NCT02942966)
- Testing
- Tack Endovascular System
- Where
- 49 sites in United States, Austria and 4 more
- Volunteers
- 233 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Peripheral Arterial Disease
Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease
This study evaluates the performance of the CorPath 200 System to deliver guide wires and balloons to blockages in the arteries of the leg.
- Trial name
- RAPID (NCT02371785)
- Testing
- CorPath 200 System
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
Ischemia
Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries…
- Trial name
- NCT02758847
- Testing
- Angiogram, Medtronic DCB (paclitaxel)/stent, Angiogram, Bard DCB (paclitaxel)/stent
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Rabih A. Chaer
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
Critical Limb Ischemia
Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia
Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.
- Trial name
- AGILITY (NCT02144610)
- Testing
- HGF Plasmid (AMG0001)
- Where
- 60 sites in United States, Belgium and 9 more
- Volunteers
- 46 people
- Sponsor
- AnGes USA, Inc.
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