Clinical trials: Critical Ischemia
Critical Illness
Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients
The main objectives of this study are to evaluate the changes in hemodynamics occurring during the remote ischemic conditioning (RIC) procedure and to compare the hemodynamic responses elicited by passive leg raising before and…
- Trial name
- HERICA (NCT06536231)
- Testing
- Remote ischemic conditioning
- Where
- Lithuania
- Volunteers
- 50 people
- Sponsor
- Lithuanian University of Health Sciences
Critical Limb Ischemia, Severe Leg Ischemia
Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of…
- Conditions
- Critical Limb Ischemia, Severe Leg Ischemia, Peripheral Artery Disease, Peripheral Vascular Disease
- Trial name
- MESENDO (NCT00721006)
- Testing
- MESENDO
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- TCA Cellular Therapy
Peripheral Artery Disease, Vascular Disease
Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)
Patients scheduled for major extremity lower amputation to receive bone marrow cells (cBMA) injected IM in the leg proximal to the amputation in the index limb to prevent ischemic wound complications after surgery.
- Conditions
- Peripheral Artery Disease, Vascular Disease, Critical Limb Ischemia
- Trial name
- MarrowCHAMP (NCT02863926)
- Testing
- Injection of cBMA aspirate into the index leg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Michael Murphy
Critical Limb Ischemia, Extracellular Matrix Alteration
Matrix Metalloproteinases in Patients With Critical Limb Ischemia Undergoing Surgical Revascularization
In the present study the investigators will evaluate MMPs. serum levels variations in patients affected by critical limb ischemia, before and after lower limb surgical revascularization through venous or prosthetic bypass.
- Conditions
- Critical Limb Ischemia, Extracellular Matrix Alteration, Peripheral Revascularisation
- Trial name
- ROMAMETA (NCT02388867)
- Testing
- Polytetrafluoroethylene (PTFE) bypass grafting., Autogenous vein bypass grafting
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Catanzaro
Diabetes, Wounds
Plerixafor in Diabetic Wound Healing
Chronic non-healing wounds represent a major source of morbidity, disability, and mortality in diabetic patients. Diabetes is the leading cause of non-traumatic limb amputations worldwide.
- Conditions
- Diabetes, Wounds, Critical Limb Ischemia
- Trial name
- MOZOBL07740 (NCT02790957)
- Testing
- Plerixafor
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- Gian Paolo Fadini
Critical Limb Ischemia, Peripheral Arterial Disease
Chelation Therapy in Diabetic Patients With Critical Limb Ischemia
This is a Pilot Trial Using Chelation Therapy for Limb Preservation in Diabetic Patients with Critical Limb Ischemia.
- Trial name
- TACT-PAD (NCT03424746)
- Testing
- disodium EDTA
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Mt. Sinai Medical Center, Miami
Critical Limb Ischemia, Peripheral Artery Disease
Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair
The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the…
- Trial name
- NCT02044003
- Testing
- Innovasc Tack Intravascular Staple System (Tack)
- Where
- 2 sites in Paraguay
- Volunteers
- 11 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Critical Limb Ischemia, Peripheral Artery Disease
Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth for the Treatment of Critical Limb Ischemia
MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia
- Trial name
- NCT01351610
- Testing
- PTA + Infusion of MSC_Apceth, PTA
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Apceth GmbH & Co. KG
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
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.
Drug Coated Balloon
Drug Coated Ballon in Critical Limb Ischemia
Evaluate the safety and efficacy of drug coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with critical limb ischemia (CLI)
- Trial name
- DCB (NCT04737291)
- Testing
- drug coated balloon
- Volunteers
- 36 people
- Sponsor
- Assiut University
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 (CLI), Diabetic Foot
Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization
The aim of the study is to evaluate the safety and feasibility of autologous bone marrow mononuclear cells autologous administered intra-arterially in the affected limb of diabetic patients with chronic critical ischemia of the…
- Trial name
- NCT00987363
- Testing
- Intraarterial infusion of autologous bone marrow cells
- Where
- 5 sites in Spain
- Volunteers
- 60 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Peripheral Artery Disease
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia
The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in…
- Trial name
- ACOART-BTK (NCT02563535)
- Testing
- DEB, PTA
- Where
- Italy
- Volunteers
- 105 people
- Sponsor
- Ospedale San Donato
Critical Limb Ischemia, Peripheral Arterial Disease
Foot Perfusion Analysis to Predict Limb Salvage
This study aims at evaluating the correlation between foot perfusion on angiographies performed before and after revascularization and limb salvage in patients with critical limb ischemia.
- Trial name
- DELTA-PERF (NCT03810469)
- Where
- France
- Volunteers
- 69 people
- Sponsor
- Centre Hospitalier de Valenciennes
Critical Limb Ischemia
The Use of FlowMet-R Technology to Predict Wound Healing in CLI Patients in a Wound Care Center Setting
Single-institution, prospective nonrandomized pilot study of critical limb ischemia patients with planned lower extremity revascularization will undergo Flowmet-D measurements in a wound care center setting to determine threshold…
- Trial name
- NCT05455554
- Testing
- Flowmet-D, ABI
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Stanford University
Cardiovascular Disease, Aortic Dissection
Additive Anti-inflammatory Action for Critically Ill Patients With Cardiovascular Surgery (Xuebijing) IV
XueBiJing, a Chinese herbal derived therapeutic, has been approved to treat severe infections (sepsis) in critically ill patients (China Food and Drug Administration; Beijing, China, Number Z20040033).
- Conditions
- Cardiovascular Disease, Aortic Dissection, Coronary Artery Disease, Valve Heart Disease
- Trial name
- NCT04993794
- Testing
- XueBiJing Injection, Normal saline
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Nanjing Medical University
Critical Limb Ischemia, Arteriosclerosis Obliterans
Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia
Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of muscle injury.
- Conditions
- Critical Limb Ischemia, Arteriosclerosis Obliterans, Peripheral Arterial Disease, Thromboangiitis Obliterans
- Trial name
- NCT02864654
- Testing
- ADRC injection, ADRC isolation, Liposuction
- Where
- Russia
- Volunteers
- 9 people
- Sponsor
- Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Critical Limb Ischemia, Ischemia
HemaTrate™ in the Treatment of Critical Limb Ischemia
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia.
- Trial name
- NCT03809494
- Testing
- HemaTrate™ Blood Filtration system, Saline
- Where
- 3 sites in United Kingdom
- Volunteers
- 2 people
- Sponsor
- Cook Research Incorporated
Critical Limb Ischemia
Treatment of PAD by Platelet Lysate for Therapeutic Angiogenesis
Induction of autologous angiogenesis in patients with critical limb ischemia using platelet lysate.
- Trial name
- NCT02941419
- Testing
- Platelet lysate
- Volunteers
- 10 people
- Sponsor
- University of Jordan