Clinical trials: Critical Limb Ischemia (CLI)
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.
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 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 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, Vascular Diseases
A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia
The purpose of the study is to confirm the feasibility of study procedures and the tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)
- Conditions
- Critical Limb Ischemia, Vascular Diseases, Peripheral Arterial Disease
- Trial name
- NCT02016755
- Testing
- HGF Plasmid
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- AnGes USA, 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
Aspirin and Clopidogrel Reactivity in Patients With Critical Limb Ischemia (CLI)
Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity.
- Trial name
- NCT02094755
- Testing
- Blood draw only
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Southern California
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, 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, 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 (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
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
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