Clinical trials: Critical Limb Ischemia (CLI)
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
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease
The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to peripheral…
- Trial name
- NCT05854641
- Testing
- Stempeucel®
- Where
- Malaysia
- Volunteers
- 10 people
- Sponsor
- Cell Biopeutics Resources Sdn Bhd
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)
Clinical Trial I/II Opened, Randomized and Controlled for the Study of the Use of Stem Cells Therapy in Insulinized Diabetic Patients Type 2 With Critical Ischemia in Lower Limbs (CLI): Study of the Needs of Insulin
To study the effect of the stem cells therapy autologous mononuclear from the bone marrow, autologous progenitor endothelial CD133 cells from the bone marrow and autologous mesenchymal stem cells from adipose tissue on the…
- Trial name
- NCT02287974
- Testing
- Stem cell infusion
- Where
- 2 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
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
Peripheral Vascular Disease, Critical Limb Ischemia
Near Infrared Spectroscopy and Transcutaneous Oxygen Pressure in Critical Limb Ischemia Before and After Treatment
Comparison of two non-invasive methods for measuring tissue oxygenation. One is Transcutaneous Oxygen Pressure (TCPO2) and the other is the new method of Near Infrared Spectroscopy (NIRS) - near infrared spectroscopy in patients…
- Trial name
- NIRS (NCT01459341)
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- Carmel Medical Center
Ischemia
Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI)
Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in vasculogenesis
- Trial name
- NCT00498069
- Testing
- Harvest Smartprep2 BMAC System, SmartPReP2 BMAC System
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Harvest Technologies
Critical Limb Ischemia, Drug Effect
Comparison of Sirolimus vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia
The objective of this study is to compare the remote patency of paclitaxel versus sirolimus eluting balloons in patients with CLI undergoing tibial artery revascularization.
- Trial name
- DebateBTKDuell (NCT04594889)
- Testing
- angioplasty
- Where
- Italy
- Volunteers
- 170 people
- Sponsor
- Ospedale San Donato
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.
Peripheral Vascular Diseases, Arterial Occlusive Diseases
Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
The purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem cell dysfunction in patients with CLI, and…
- Conditions
- Peripheral Vascular Diseases, Arterial Occlusive Diseases, Leg Ulcer, Gangrene
- Trial name
- JUVENTAS (NCT00371371)
- Testing
- Bone marrow punction, BM-MNC infusion
- Where
- Netherlands
- Volunteers
- 160 people
- Sponsor
- UMC Utrecht
Arterial Occlusive Disease, Ischemia
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-2)
The purpose of this study is to evaluate whether intramuscular injections of NL003 into the calf is safe and effective in the treatment of critical limb ischemia
- Conditions
- Arterial Occlusive Disease, Ischemia, Ulcers, Peripheral Vascular Disease
- Trial name
- NCT04274049
- Testing
- NL003, Normal Saline
- Where
- 21 sites in China
- Volunteers
- 242 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Critical Limb Ischemia (CLI), Diabetes
Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients
A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose. The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs…
- Trial name
- NCT01257776
- Testing
- Autologous adipose derived mesenchymal stem cells
- Where
- 2 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Diabetes Mellitus, Critical Limb Ischemia
Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia
The ECAD-CLI is an investigator-driven, prospective, single-center study. The aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in…
- Conditions
- Diabetes Mellitus, Critical Limb Ischemia, Critical Lower Limb Ischemia, Diabetic Foot
- Trial name
- ECAD-CLI (NCT03636867)
- Testing
- data and specimen collection
- Where
- Italy
- Volunteers
- 236 people
- Sponsor
- Maria Cecilia Hospital
Critical Limb Ischemia
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI).
- Trial name
- REVIVE (NCT01483898)
- Testing
- Ixmyelocel-T
- Where
- 86 sites in United States
- Volunteers
- 41 people
- Sponsor
- Vericel Corporation
Peripheral Vascular Diseases
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease
To assess the proximity of the catheter to the vessel wall and to correlate excised tissue with images collected by the integrated Optical coherence Tomography (OCT) imaging system.
- Trial name
- NightHawk (NCT00516308)
- Testing
- NightHawk
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- FoxHollow Technologies
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 (CLI)
Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects…
- Trial name
- NCT03006770
- Testing
- PLX-PAD
- Where
- 57 sites in United States, Bulgaria and 7 more
- Volunteers
- 213 people
- Sponsor
- Pluristem Ltd.
Arterial Occlusive Disease, Ischemia
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-1)
To evaluate the safety and efficacy of recombinant human hepatocyte growth factor (HGF) bare plasmid injection for local intramuscular injection in the treatment of patients with severe lower limb hemorrhagic disease (Rutherford…
- Conditions
- Arterial Occlusive Disease, Ischemia, Ulcers, Peripheral Vascular Disease
- Trial name
- NCT04275323
- Testing
- NL003, Normal Saline
- Where
- 13 sites in China
- Volunteers
- 302 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Critical Limb Ischemia, Peripheral Arterial Disease
ALD-301 for Critical Limb Ischemia, Randomized Trial
This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLI-001 (NCT00392509)
- Testing
- ALDH-br bone marrow cells vs. mononuclear bone marrow cells
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Aldagen
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.