Clinical trials: Critical Ischemia
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); This trial is designed to assess the efficacy and safety of the…
- Trial name
- NCT00059657
- Testing
- Ecraprost in lipid emulsion
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 280 people
- Sponsor
- Tanabe Pharma Corporation
Arterial Occlusive Disease, Ulcers
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
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, Ulcers, Ischemia, Peripheral Vascular Disease
- Trial name
- NL003CLI-II (NCT01548378)
- Testing
- NL003, Normal Saline
- Where
- 9 sites in China
- Volunteers
- 200 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Critical Limb Ischemia
Proteomics and Stem Cell Therapy as a New Vascularization Strategy
Neovascularization (NV) is the innate capability to enlarge collateral arteries ("arteriogenesis"), and to stimulate growth of new capillaries, arterioles and venules at the tissue level ("angiogenesis").
- Trial name
- NCT02802852
- Testing
- Pneumatic calf compression, Filgrastim
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Illinois Chicago
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
Critical Limb Ischemia, Peripheral Arterial Occlusive Disease
Cryoplasty CLIMB-registry
In 5 Belgian hospitals, the data of 100 CLI-patients receiving the cryoplasty technique to treat their infrapopliteal arterial lesions will be collected.
- Trial name
- CLIMB (NCT00459888)
- Testing
- PolarCath Peripheral Dilatation System (Boston Scientific)
- Where
- 4 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Flanders Medical Research Program
Critical Limb Ischemia
Safety Study of Gene Therapy in Treating Critical Leg Ischemia
The purpose of this study is to determine the safety, tolerability and preliminary efficacy of intramuscular injections of VM202 for subjects with critical limb ischemia.
- Trial name
- NCT00696124
- Testing
- VM202 2 mg, VM202 4 mg, VM202 8 mg
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Helixmith Co., Ltd.
Critical Limb Ischemia, Buerger Disease
Study to Assess the Efficacy and Safety of CLBS12 in Patients with Critical Limb Ischemia (CLI)
A prospective, open label, controlled, randomized, double arm, multi-center study to assess the efficacy and safety of CLBS12 in patients with critical limb ischemia (CLI) due to arteriosclerosis obliterans (ASO) with a single…
- Conditions
- Critical Limb Ischemia, Buerger Disease, Thromboangiitis Obliterans, Atherosclerosis Obliterans
- Trial name
- NCT02501018
- Testing
- CLBS12, SOC
- Where
- 12 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Lisata Therapeutics, Inc.
Chronic Critical Limb Ischemia, Peripheral Vascular Diseases
Study to Evaluate the Safety & Performance of the Xpert(TM) Stent in Treating Below-the-knee Lesions in Patients Undergoing Percutaneous Intervention for Chronic CLI.
The purpose of this study is to evaluate the safety and performance of the Xpert(TM) self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in patients undergoing percutaneous intervention for the…
- Trial name
- XCELL (NCT00515346)
- Testing
- Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- VIVA Physicians
Limb Ischemia
Characteristics and Prognosis of Patients With Critical Ischemia at High Risk of Amputation Managed by Endovascular Bypass: a Retrospective Study of 15 Patients
Obliterative arterial disease of the lower limbs (AOMI) is associated with a high risk of cardiovascular events, with a linear relationship between a fall in the systolic pressure index and a risk of cardiovascular morbidity and…
- Trial name
- Pontage (NCT04066387)
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Ischemic Stroke
Neuroprotective Effects of Xenon Treatment in Patients with Cerebral Infarction
In the Russian Federation, ischemic cerebral infarction is recorded annually in more than 450,000 people. It is the second most common cause of death after coronary heart disease.
- Trial name
- NCT05335109
- Testing
- Xenon, Oxygen 30 %
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Negovsky Reanimatology Research Institute
Critical Limb Ischemia
Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.
Clinical trial phase I / II, prospective, multicenter, open, randomized, parallel-groups controlled by two levels of dose to assess the safety and feasibility of the infusion of mesenchymal stem cells from adipose tissue…
- Trial name
- NCT01745744
- Testing
- Mesenchymal stem cells from adipose tissue
- Where
- 2 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Lower Extremity Ischemia, Leg Ulcer
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.
- Conditions
- Lower Extremity Ischemia, Leg Ulcer, Peripheral Vascular Disease, Diabetic Foot
- Trial name
- NCT01903044
- Testing
- BM-MNC injection
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- Pontifícia Universidade Católica do Paraná
Critical Limb Ischemia
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
- Trial name
- NCT01870401
- Testing
- Lutonix DCB, Uncoated PTA Catheter
- Where
- 51 sites in United States, Austria and 6 more
- Volunteers
- 442 people
- Sponsor
- C. R. Bard
Critically Ill, Cancer
Spironolactone Administration to Prevent Ischemic Kidney Injury in Critically Ill Cancer Patients
Acute kidney injury frequently affects cancer patients. The main cause of acute kidney injury is ischemic damage caused by transient decrease in renal blood flow, followed by blood flow restoration and accompanying reperfusion…
- Trial name
- SPIROCAN (NCT02531412)
- Testing
- Spironolactone
- Where
- Mexico
- Volunteers
- 24 people
- Sponsor
- Instituto Nacional de Cancerologia de Mexico
Renal Impairment, Limb Ischemia, Critical
Ultra-low Dose Contrast for Endovascular Procedures
The purpose of this protocol is to study the safety and feasibility of using ultra-low dose iodinated contrast agent for infrainguinal endovascular revascularization procedures in patients with chronic limb-threatening lower limb…
- Trial name
- ULTRA-LOW (NCT06835127)
- Testing
- Infrainguinal peripheral endovascular revascularization
- Where
- Greece
- Volunteers
- 18 people
- Sponsor
- Attikon Hospital
Chronic (> 2 Weeks) Critical Ischemia With Skin Defect in Lower Limbs
Viennese Registry on Patients With Chronic Critical Limb Ischemia
The rationale of this study is to establish a registry to detect and follow patients with CLI treated in Vienna. The Vienna CLI registry is meant to document the incidence, prevalence, and actual outcome of CLI patients in a real…
- Trial name
- NCT01233141
- Where
- Austria
- Volunteers
- 400 people
- Sponsor
- Medical University of Vienna
Peripheral Arterial Disease
Iloprost Therapy in Patients With Critical Limb Ischemia
Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.
- Trial name
- NCT01458041
- Testing
- Iloprost (Ilomedin, BAYQ6256)
- Where
- Hungary
- Volunteers
- 126 people
- Sponsor
- Bayer
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 4.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03111238
- Testing
- REX-001
- Where
- 15 sites in Czechia, Germany and 4 more
- Volunteers
- 3 people
- Sponsor
- Ixaka Ltd
Lower Limb Ischaemia
Development and Validation of a Clinical Prediction Rule for Lower Limb Critical Limb Ischaemia (PREDICCMI)
Critical limb ischaemia (CLI) is the most serious stage of peripheral occlusive arterial disease (POAD). Despite progress in the revascularization procedures, half these patients experience amputation or death after one year.
- Trial name
- PREDICCMI (NCT02637492)
- Testing
- Collection of clinical signs and symptoms
- Where
- 3 sites in France
- Volunteers
- 603 people
- Sponsor
- University Hospital, Bordeaux
Pressure Ulcer, Ischemic
Evaluation of the Impact of the Repositioning Schedule Adapted to the Risk of Pressure Ulcer of Patients in Intensive Care Unit
Pressure ulcers represent a major health issue because of their high incidence and their important consequences. There is an important risk of pressure ulcer acquisition for ICU patients with acute organ failure(s).
- Conditions
- Pressure Ulcer, Ischemic, Ischemic Ulcer
- Trial name
- PROMESREA (NCT04550182)
- Testing
- Positioning schedule
- Where
- France
- Volunteers
- 1,232 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris