Clinical trials: Critical Ischemia
Critical Limb Ischemia (CLI)
Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
A Phase III study of PLX-PAD for CLI patients with minor tissue loss who are unsuitable for revascularization has been initiated (PLX-CLI-03, PACE study).
- Trial name
- NCT03886506
- Testing
- PLX-PAD
- Where
- 2 sites in United States
- Sponsor
- Pluristem Ltd.
Critical Limb-Threatening Ischemia, Critical Limb Ischemia
Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia
The objective of this prospective, multi-center, clinical investigation is to evaluate the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions.
- Conditions
- Critical Limb-Threatening Ischemia, Critical Limb Ischemia, Critical Lower Limb Ischemia
- Trial name
- MAGNITUDE-BTK (NCT06075940)
- Testing
- MAGNITUDE BRS
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- R3 Vascular Inc.
Peripheral Artery Disease, Vascular Disease
Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging
This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an endovascular intervention of the…
- Conditions
- Peripheral Artery Disease, Vascular Disease, Critical Limb Ischemia
- Trial name
- INVADER_MRI (NCT02807779)
- Testing
- Dexamethasone infusion, Drug coated balloon, Plain balloon angioplasty
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of California, San Francisco
Peripheral Vascular Diseases
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
- Trial name
- PROOF (NCT00504088)
- Testing
- Bypass, Silverhawk Plaque Excision
- Where
- 31 sites in United States
- Sponsor
- FoxHollow Technologies
Critical Limb Ischemia, Arterial Occlusive Disease
Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia
The hypothesis behind the trial is the concept that Pregabalin is effective in reducing pain at rest in lower limb ischemia, and the study evaluates active treatment or placebo added to the regular pain regimens for these…
- Conditions
- Critical Limb Ischemia, Arterial Occlusive Disease, Pain, Ischemia
- Trial name
- NCT00403780
- Testing
- pregabalin
- Where
- 3 sites in Sweden
- Volunteers
- 18 people
- Sponsor
- Karolinska Institutet
Critical Limb Ischemia
Serrantor OCT Study
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
- Trial name
- NCT06434194
- Testing
- Serranator PTA Serration Catheter, PTA (Standard of Care)
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cagent Vascular LLC
Critical Limb Ischemia, Ischemia
VEGF Gene Transfer for Critical Limb Ischemia
The purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in patients with moderate to high-risk Critical Limb Ischemia…
- Conditions
- Critical Limb Ischemia, Ischemia, Leg Ulcer
- Trial name
- NCT00304837
- Testing
- pVGI.1 (VEGF-2)
- Where
- 3 sites in United States
- Sponsor
- Losordo, Douglas, M.D.
Critical Limb Ischemia
Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease
Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study in treating 18 recipients with ischemic limb…
- Trial name
- NCT02336646
- Testing
- Allogenic MSC, Normal saline
- Where
- Taiwan
- Volunteers
- 18 people
- Sponsor
- Taiwan Bio Therapeutics Inc.
Peripheral Artery Disease Without Critical Limb Ischemia
Non-Healing Ulcers Without Critical Limb Ischemia
Background: Lower limb arterial revascularization procedures, either percutaneously or surgically performed, are an established treatment modality of ischemic foot ulcers, especially in the setting of a critical limb ischemia.
- Trial name
- NEWLI (NCT01666093)
- Testing
- Angioplasty of the lower limbs vessels
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- University Hospital, Geneva
Diabetic Foot, Gangrene; Limb
MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation
Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor…
- Conditions
- Diabetic Foot, Gangrene; Limb, Wound Infection, Wound Healing Delayed
- Trial name
- MetaMet (NCT05804565)
- Testing
- Bone Saw, Bone Cutter
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- University College Hospital Galway
Peripheral Artery Disease, Critical Limb Ischemia
Platelet Reactivity in PAD Undergoing Percutaneous Angioplasty
Dual antiplatelet therapy has a key role in a prevention of thrombosis of treated artery in patients undergoing percutaneous transluminal angioplasty (PTA).
- Conditions
- Peripheral Artery Disease, Critical Limb Ischemia, Claudication, Intermittent
- Trial name
- PAD (NCT04165629)
- Testing
- Aspirin 300mg and Clopidogrel 300mg
- Where
- Serbia
- Volunteers
- 450 people
- Sponsor
- Clinical Centre of Serbia
End Stage Renal Failure, Neuropathic Pain
Qutenza for Critical Ischaemia in End Stage Renal Failure
Critical ischaemia is pain at rest as the result of poor blood flow and lack of oxygen being delivered to the tissues. It normally affects the hands and feet and can be very debilitating.
- Trial name
- NCT01704339
- Testing
- QUTENZA
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Emma Aitken
Peripheral Arterial Disease
A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD
The objective of the clinical trial is to gather evidence on the safety, performance and clinical efficacy Vibrato Sleeve TUS in people with peripheral artery disease (PAD).
- Trial name
- Concerto (NCT05100745)
- Testing
- Therapeutic Device
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Vibrato Medical, Inc.
Critical Limb Ischemia (CLI)
Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System
This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal clinical study in which subjects are evaluated for prevention of major limb amputation in the treatment of non-reconstructable…
- Trial name
- CLIRST III (NCT02538978)
- Testing
- Autologous Bone Marrow Concentrate (aBMC)
- Volunteers
- 224 people
- Sponsor
- Cesca Therapeutics, Inc.
Peripheral Arterial Disease, Peripheral Vascular Diseases
Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access
This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat subjects with critical limb ischemia (CLI) caused by severe PAD.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Critical Limb Ischemia
- Trial name
- MOBILE-CA (NCT02474121)
- Testing
- Bone marrow concentration device
- Where
- 9 sites in United States
- Sponsor
- Zimmer Biomet
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
PAD, Infrapopliteal Lesions
European Study of POBA Versus Cotavance(R) Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia (EURO CANAL)
To evaluate the procedural safety and to identify and characterize therapeutic and functional endpoint assessments in subjects with documented critical limb ischemia who received treatment with the Cotavance Paclitaxel-Coated…
- Trial name
- NCT01260870
- Testing
- Cotavance Paclitaxel Coated Balloon, Standard balloon angioplasty
- Where
- 6 sites in Austria, Belgium and 2 more
- Volunteers
- 44 people
- Sponsor
- Bayer
Critical Limb Ischemia
Drug-Eluting Balloon Angioplasty Versus Bypass Surgery as First-Line Strategies in Infrageniculate Arterial Disease for Critical Limb Ischemia in Type 2 Diabetic Pacients: a Randomised Controlled Clinical Trial
The aim of this study is to evaluate the outcomes of drug-eluting balloon angioplasty and vein bypass surgery in diabetic patients with critical limb ischemia due to infrapopliteal arterial disease.
- Trial name
- NCT04760119
- Testing
- Vein bypass surgery first strategy, Endovascular treatment first (drug coated balloon angioplasty) strategy
- Where
- Lithuania
- Volunteers
- 40 people
- Sponsor
- Lithuanian University of Health Sciences
Microbial Colonization, Coronary Artery Disease
Effect of Acute Cardiovascular Disease on Microbiome
Atherosclerotic diseases such as coronary artery disease (CAD) and peripheral arterial disease (PAD) are the leading cause of morbidity and mortality in the industrialized world.
- Conditions
- Microbial Colonization, Coronary Artery Disease, Myocardial Infarction, Acute Coronary Syndrome
- Trial name
- MIAMI (NCT05456802)
- Testing
- Standard of care treatment
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University Hospital, Essen
Peripheral Vascular Disease
Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft
Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia…
- Trial name
- NCT00067041
- Testing
- Remodulin (treprostinil sodium) Injection
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics