Clinical trials: Chronic Limb-threatening Ischemia
Lower Limb Ischemia, Peripheral Vascular Diseases
An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)
Endovascular treatment of below the knee disease is a well-established therapy to improve outcomes in patients with critical limb ischemia.
- Trial name
- RANGER-BTK (NCT02856230)
- Testing
- Ranger SL DEB
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Peripheral Arterial Disease, Chronic Limb Threatening Ischemia
Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging
The goal of this observational study is to characterise the relationships between inflammation, microcalcification and thrombus activity in atherosclerotic plaques in peripheral and systemic vascular territories in patients with…
- Trial name
- SISYPHUS (NCT07472049)
- Testing
- Whole body [68Ga]DOTATATE PET-CT, Whole body [18F]GP1 PET-CT, Whole body [18F]NaF PET-CT
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- University of Edinburgh
Critical Limb Ischemia
Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical Limb Ischemia (N-O CLI)
The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will be treated by the administration…
- Trial name
- NCT03423732
- Testing
- CardioCell
- Where
- 2 sites in Poland
- Volunteers
- 50 people
- Sponsor
- John Paul II Hospital, Krakow
Critical Limb Ischemia (CLI), Popliteal Nerve Block
Ultrasound-Guided Sciatic Popliteal Nerve Block vs. Erector Spinae Plane Block in Endovascular Management of CLI
Comparison of popliteal sciatic nerve block and erector spinae plane block (ESPB) in patients undergoing endovascular management of critical lower limb ischemia (CLI).
- Conditions
- Critical Limb Ischemia (CLI), Popliteal Nerve Block, ESPB
- Trial name
- NCT06913348
- Testing
- Popliteal sciatic nerve block
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Minia University Hospital
Critical Limb Ischemia, Atherosclerosis
Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia.
- Conditions
- Critical Limb Ischemia, Atherosclerosis, Ischemic Ulcer, Gangrene
- Trial name
- NCT01833585
- Testing
- Peripheral blood mononuclear cell
- Where
- Thailand
- Volunteers
- 8 people
- Sponsor
- Mahidol University
Critical Limb Ischemia, Buerger's Disease
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's 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 Buerger's…
- Trial name
- NCT05854615
- Testing
- Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells
- Where
- Malaysia
- Volunteers
- 3 people
- Sponsor
- Cell Biopeutics Resources Sdn Bhd
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
Critical Limb Ischemia
Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia
This is a double-blind, placebo controlled study designed to evaluate the safety and efficacy of JVS-100 given to adult subjects with critical limb ischemia (CLI).
- Trial name
- NCT01410331
- Where
- 7 sites in United States, India
- Volunteers
- 48 people
- Sponsor
- Juventas Therapeutics, Inc.
Peripheral Vascular Disease, Intermittent Claudication
DURABILITY-200: EverFlex 200mm Long Nitinol Stents in TASC C&D Femoropopliteal Lesions
The objective of this clinical investigation is to evaluate the long-term (up to 12 months) outcome of the 200 mm long self-expanding nitinol EverFlex (ev3) stent in long femoropopliteal lesions (TASC C \& D) Is is the first time…
- Conditions
- Peripheral Vascular Disease, Intermittent Claudication, Critical Limb Ischemia
- Trial name
- NCT00637741
- Testing
- Everflex 200
- Where
- 2 sites in Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Flanders Medical Research Program
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
Arterial Occlusive Diseases
Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)
Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized…
- Trial name
- NCT00282646
- Testing
- intraarterial stem cell therapy, Stem cells
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Johann Wolfgang Goethe University Hospital
Peripheral Artery Disease, Intermittent Claudication
Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany
This proposed study will be conducted to support real-world-evidence on the extent of best medical treatment for secondary prevention of patients with symptomatic peripheral arterial occlusive disease (PAOD) for prevention of…
- Conditions
- Peripheral Artery Disease, Intermittent Claudication, Critical Limb Ischemia
- Trial name
- NCT03909022
- Volunteers
- 60,000 people, healthy volunteers welcome
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Peripheral Arterial Disease, Critical Limb-Threatening Ischaemia
Shockwave ®S4 Catheter IVL to Treat Infrapopliteal Calcified Stenoses and/or Occlusions in CLTI Patients (LEGACY)
The study will evaluate the safety and efficacy of Peripheral Intravascular Lithotripsy system with Shockwave S4 catheter® for the treatment of de novo, re-stenosis or re-occlusive,calcified chronic total occlusion (CTOs) lesions…
- Trial name
- LEGACY (NCT05755412)
- Where
- 6 sites in Italy
- Volunteers
- 9 people
- Sponsor
- EndoCore Lab s.r.l.
Critical Limb Ischemia
Impact of Critical Limb Ischemia on Long Term Cardiac Mortality in Diabetic Patients Undergoing Percutaneous Coronary Revascularization
Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary intervention (PCI) in whom development of critical limb ischemia was prospectively assessed by a dedicated diabetic foot clinic.
- Trial name
- NCT01676519
- Testing
- PCI
- Where
- Italy
- Volunteers
- 764 people
- Sponsor
- Ospedale San Donato
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 Lower Limb Ischemia, Critical Limb Ischemia
Evaluation of Carbothera in the Treatment of Foot Ulcers
Foot ulceration usually precedes more serious foot complications such as infection, gangrene or amputation. The risk of developing foot ulcers has been estimated to be higher in individuals with kidney disease.
- Conditions
- Critical Lower Limb Ischemia, Critical Limb Ischemia, Foot Ulcer, Skin Ulceration
- Trial name
- NCT02239419
- Testing
- CO2-Enriched Tap Water (Carbothera), Non-CO2-Enriched Tap Water
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- University of Manitoba
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
Study of the Clinical Efficacy of Autologous SCT in Patients With Critical Limb Ischemia
Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia
- Trial name
- NCT01311011
- Testing
- SCT
- Where
- Saudi Arabia
- Volunteers
- 26 people
- Sponsor
- King Faisal Specialist Hospital & Research Center
Peripheral Vascular Disease, Critical Limb Ischemia
Drug Eluting Stents In The Critically Ischemic Lower Leg
The Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia.
- Trial name
- DESTINY (NCT00510393)
- Testing
- XIENCE V everolimus eluting coronary stent system, MULTILINK VISION coronary stent system
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 140 people
- Sponsor
- Flanders Medical Research Program
Peripheral Artery Disease
Home-based Exercise Therapy in Patients With Moderate to Severe Peripheral Artery Disease
Peripheral arterial disease (PAD) is a chronic atherosclerotic condition associated with impaired mobility, reduced quality of life, cardiovascular events, and risk of lower limb amputation.
- Trial name
- PILOT-PADCYCLE (NCT07655206)
- Testing
- Home-Based Exercise Therapy Using Portable Pedal Exerciser
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- Laval University