Clinical trials: Lower Extremity Ischemia
Critical Limb Ischemia
Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores…
- Trial name
- NCT01245335
- Testing
- BMAC injection
- Where
- 34 sites in United States
- Volunteers
- 97 people
- Sponsor
- Harvest Technologies
Diabetic Foot, Critical Limb Ischemia
A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
The purpose of this study is to determine whether the method (implanting stem cells derived from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the management of diabetic foot ischemia, the…
- Conditions
- Diabetic Foot, Critical Limb Ischemia, Leg Ulcers
- Trial name
- NCT00922389
- Testing
- will receive G-CSF and peripheral blood derived mononuclear cells, G-CSF, Standard Therapy
- Where
- India
- Volunteers
- 36 people
- Sponsor
- Beike Biotech India Pvt.ltd
Peripheral Arterial Disease, Critical Limb Ischemia
BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI
The purpose of this study is to determine if an MRI technique called Blood Oxygen Level Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment with standard endovascular therapy in patients…
- Trial name
- NCT02601430
- Testing
- BOLD-MRI
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Zimmer Biomet
Acute Lower Limb Arterial Occlusion
The ArtixASCEND Study
This study is a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
- Trial name
- NCT07135895
- Testing
- Artix Thrombectomy System
- Where
- 23 sites in United States
- Volunteers
- 250 people
- Sponsor
- Inari Medical
Chronic Limb Ischemia
Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Atherectomy (ATX)-Based Revascularization
This is a prospective, multi-center, randomized pilot study to document the effects of adventitial delivery of dexamethasone after atherectomy-based revascularizations of lesions below the knee in symptomatic patients with…
- Trial name
- LIMBO-ATX (NCT02479620)
- Testing
- Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL
- Where
- 10 sites in United States
- Volunteers
- 120 people
- Sponsor
- Mercator MedSystems, Inc.
Lower Extremity Acute Limb Ischemia, LE ALI
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
The primary objective of this study is to collect safety and performance data on the Indigo Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
- Trial name
- STRIDE (NCT04144959)
- Testing
- Indigo Aspiration System
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 119 people
- Sponsor
- Penumbra Inc.
Acute Limb Ischemia
Evaluation of MST-188 in Acute Lower Limb Ischemia
The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether treatment with MST-188 results in more rapid…
- Trial name
- NCT02093468
- Testing
- MST-188, Saline
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- Mast Therapeutics, Inc.
Critical Limb Ischemia
Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Critical Limb Ischemia
The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain…
- Trial name
- NCT06359912
- Testing
- EPCs, Clinical standard treatment (CST)
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Allife Medical Science and Technology 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
Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for…
- Trial name
- NCT02099500
- Testing
- Liposuction, Stem Cell Injection
- Where
- United States
- Sponsor
- Ageless Regenerative Institute
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase…
- Conditions
- Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans
- Trial name
- NCT07023965
- Testing
- NL003
- Where
- 5 sites in China
- Volunteers
- 542 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Peripheral Arterial Disease, Critical Lower Limb Ischemia
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
- Trial name
- HEAL (NCT04110327)
- Testing
- MicroStent
- Where
- 10 sites in Austria, Belgium and 3 more
- Volunteers
- 300 people
- Sponsor
- Micro Medical Solution, Inc.
Peripheral Arterial Disease
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the…
- Trial name
- Axys ACHIEVE (NCT04282161)
- Testing
- Axys EX device
- Sponsor
- Medtronic Endovascular
Stroke, Ischemic, Stroke Hemorrhagic
Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke
A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the Keeogo™ Dermoskeleton in subjects with hemiparesis due to ischemic or hemorrhagic stroke.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Hemiparesis
- Trial name
- NCT03986320
- Testing
- Keeogo™ Dermoskeleton
- Where
- 4 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- B-Temia, Inc.
Peripheral Arterial Disease, Critical Lower Limb Ischemia
Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon
To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.
- Trial name
- SWING (NCT04107298)
- Testing
- SUNDANCE™ Drug Coated Balloon
- Where
- 8 sites in Australia, Austria and 3 more
- Volunteers
- 35 people
- Sponsor
- SurModics, Inc.
Lower Extremity Swelling Acute
Physician Clinical Trial Policy (CTP) Neurological Ischemia Lower Extremity Pain and Swelling
Physician Clinical Trial Policy (CTP) to evaluate the efficacy treatment of lower extremity pathologies derived from neurological ischemia disorders using the combination of Monochromatic Infrared Photo Energy (MIRE) and…
- Trial name
- DTSC (NCT01979367)
- Testing
- Anodyne
- Volunteers
- 1,000 people
- Sponsor
- American Association of Sensory Electrodiagnostic Medicine
Peripheral Vascular Disease
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD).
- Trial name
- NCT00059644
- Testing
- Ecraprost in lipid emulsion
- Where
- 27 sites in United States, United Kingdom
- Volunteers
- 560 people
- Sponsor
- Tanabe Pharma Corporation
Critical Limb Ischemia, Peripheral Vascular Disease
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to…
- Conditions
- Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain
- Trial name
- NCT00060996
- Testing
- Remodulin® (treprostinil sodium) Injection
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics