Clinical trials: Critical Ischemia Limb
Critical Lower Limb Ischemia
Trans-pedal Access for Endovascular Revascularization in Complex Infra-popliteal Lesions in Critically Ischemic Limb
Background: critical limb ischemia is one of the most challenging cases we face nowadays with high risk for amputation, retrograde trans-pedal angioplasty offers an alternative technique after failure of traditional ante-grade…
- Trial name
- NCT05436405
- Testing
- Trans-pedal access for endovascular revascularization in complex infra-popliteal lesions in critically ischemic limb
- Where
- Egypt
- Volunteers
- 96 people
- Sponsor
- Mansoura University
Critical Limb Ischemia
Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients.
This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared to the standard treatment (clopidogrel plus aspirin) in patients with critical limb ischemia undergoing infrapopliteal arterial…
- Trial name
- AGRIPPA (NCT04229264)
- Testing
- Apixaban, ASA, Clopidogrel 75mg
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Science Valley Research Institute
Atherosclerosis, Peripheral Artery Disease
The ABSORB BTK (Below The Knee) Clinical Investigation
The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with critical limb ischemia (CLI) following…
- Conditions
- Atherosclerosis, Peripheral Artery Disease, Peripheral Vascular Disease, PAD
- Trial name
- NCT01341340
- Testing
- Everolimus Eluting BVS
- Where
- Belgium
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
End-stage Renal Disease, Critical Limb Ischemia
Open Versus Endovascular Revascularization in Patients With End-stage Renal Disease
Treatment of patients with end-stage renal disease and critical limb ischemia still poses challenges to vascular medicine due to limited survival, comorbidities and infrapopliteal involvement of arteriosclerosis in these…
- Trial name
- OERESRD (NCT03293589)
- Testing
- open revascularization, endovascular revascularization
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- University Hospital Erlangen
Chronic Limb Threatening Ischemia, Infrapopliteal Arterial Occlusive Disease
Revascularization of Single Vesrus Multiple Infrapopliteal Vessels in Chronic Limb Threatening Ischemia
This interventional prospective study aims to assess the effectiveness of single vessel versus multiple vessel infrapopliteal angioplasty in patients with chronic threatening limb ischemia .
- Trial name
- NCT07068789
- Testing
- balloon angioplasty
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Sohag University
Diabetes Mellitus, Claudication, Intermittent
Additional Hyperbaric Oxygen After Lower Extremity Amputation
This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or…
- Conditions
- Diabetes Mellitus, Claudication, Intermittent, Critical Limb Ischemia, Osteomyelitis
- Trial name
- AHOLEA (NCT03594344)
- Testing
- Hyperbaric oxygen therapy
- Where
- 2 sites in Norway
- Volunteers
- 120 people
- Sponsor
- Oslo University Hospital
Critical Limb Ischemia
External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality
In this clinical research study the investigators will test the efficacy of an innovative, non-invasive methodology to reduce mortality and lower limb loss among high-risk medically-underserved patients with cardiovascular…
- Trial name
- ArtAssist (NCT02054416)
- Testing
- ArtAssist© Device
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Temple University
Critical Limb Ischemia
To Evaluate the Safety and Efficacy of IM and IV Administration of Autologous ADMSCs for Treatment of CLI
Various preclinical animal studies have shown the potential of stem cells in re-vascularising ischemic limbs and promoting collateral vessel formation.
- Trial name
- NCT02145897
- Testing
- Autologous Stromal Vascular Fraction (SVF), Autologous Adipose Derieved MSCs, Control
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Kasiak Research Pvt. Ltd.
Diabetic Foot, Critical Limb Ischemia
Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is…
- Conditions
- Diabetic Foot, Critical Limb Ischemia, Mesenchymal Stem Cells, Umbilical Cord
- Trial name
- NCT01216865
- Testing
- umbilical cord mesenchymal stem cells, Standard Therapy
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Qingdao University
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
- Conditions
- Critical Limb Ischemia, Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
- Trial name
- NCT05313165
- Testing
- LimFlow Stent Graft System
- Where
- 30 sites in United States
- Volunteers
- 100 people
- Sponsor
- LimFlow, Inc.
Critical Lower Limb Ischemia, Peripheral Artery Disease
Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore
Extensive arterial occlusion significantly reduces arterial perfusion, and may eventually lead to Critical Limb Ischemia (CLI). The pathology gives rise to symptoms such as ischemic pain, slow healing wounds at lower extremity…
- Trial name
- PRISTINE (NCT04534257)
- Testing
- SELUTION Sirolimus DCB
- Where
- Singapore
- Volunteers
- 75 people
- Sponsor
- Singapore General Hospital
Stroke, Brain Infarction
Critical Periods After Stroke Study (CPASS)
To perform an exploratory single center randomized study that will form the basis for a larger scale, more definitive randomized clinical trial to determine the optimal time after stroke for intensive motor training.
- Conditions
- Stroke, Brain Infarction, Brain Ischemia, Cerebral Infarction
- Trial name
- CPASS (NCT02235974)
- Testing
- Early Intensive upper extremity motor training, Sub-acute intensive upper extremity motor training, Chronic intensive upper extremity motor training
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- MedStar National Rehabilitation Network
Ischemia Lesions
Polytetrafluoroethylen (PTFE) Vascular Prostheses With Heparin Bonded Luminal Surfaces vs Crude ePTFE
Open repair could be recommended in a first line of treatment to revascularize critical limb ischemia patients or performed in a second line of treatment in case of failure of endovascular repair.
- Trial name
- REPLACE (NCT03430076)
- Testing
- revascularization, Propaten®, Crude PTFE
- Where
- 21 sites in France
- Volunteers
- 228 people
- Sponsor
- Nantes University Hospital
Critical Limb Ischemia
Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities
Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.
- Trial name
- LOA (NCT00767923)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- HyperMed
Critical Limb Ischemia
FAZA PET/MRI in CLI Patients Pre and Post Revascularization
Peripheral artery disease is a worldwide problem, leading to high mortality and mobility. Critical limb ischemia (CLI) is associated with high risk of amputation with the subsequent decreased in life quality.
- Trial name
- NCT04054609
- Testing
- FAZA PET/MRI scan
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University Health Network, Toronto
Peripheral Vascular Diseases
Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes…
- Trial name
- TAMARIS (NCT00566657)
- Testing
- riferminogene pecaplasmid
- Where
- 32 sites in United States, Argentina and 30 more
- Volunteers
- 525 people
- Sponsor
- Sanofi
Limb Ischemia, Diabetic Foot
Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia
Phase II national, multicenter, double-blind, randomized, placebo-controlled, phase-3 clinical trial of 3 parallel groups.
- Trial name
- NCT04466007
- Testing
- High dose allogeneic mesenchymal stromal cells, Low dose allogeneic mesenchymal stromal cells
- Where
- 10 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Leg Ulcer, Diabetic Foot
Autologous Transplantation of BM-ECs With Platelet-Rich Plasma Extract for the Treatment of Critical Limb Ischemia
The intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE) for the treatment of critical limb…
- Conditions
- Leg Ulcer, Diabetic Foot, Gangrene, Peripheral Vascular Disease
- Trial name
- NCT02993809
- Testing
- BM-ECs and PRPE, BM-ECs
- Volunteers
- 40 people
- Sponsor
- South China Research Center for Stem Cell and Regenerative Medicine
Arterial Occlusive Disease, Peripheral Vascular Disease
Study of HGF Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia
The primary purpose of this study was to assess the overall safety of different dose regimens of AMG0001 (HGF transferred via plasmid vector) as well as evaluate the improvement of blood perfusion in subjects with critical limb…
- Conditions
- Arterial Occlusive Disease, Peripheral Vascular Disease, Ischemia
- Trial name
- NCT00060892
- Testing
- HGF plasmid
- Where
- 24 sites in United States
- Volunteers
- 104 people
- Sponsor
- AnGes USA, Inc.
Critical Limb Ischemia
Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization
Peripheral Arterial Occlusive Disease is associated with a high risk of cardiovascular events. The critical ischemia stage represents the most severe stage of Peripheral Arterial Occlusive Disease, associated with decubitus pain…
- Trial name
- CLI ENDOVASC (NCT04312451)
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Fondation Hôpital Saint-Joseph