Clinical trials: Chronic Limb Threatening Ischemia
Peripheral Arterial Disease, Critical Limb Ischemia
Swedish Drug-elution Trial in Peripheral Arterial Disease
Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries.
- Conditions
- Peripheral Arterial Disease, Critical Limb Ischemia, Intermittent Claudication
- Trial name
- SWEDEPAD (NCT02051088)
- Testing
- Revascularization with drug-eluting technology, Revascularization without drug-eluting technology, drug-coated balloons and/or drug-eluting stents
- Where
- Sweden
- Volunteers
- 3,556 people
- Sponsor
- Sahlgrenska University Hospital
Critical Limb Ischemia
Study to Assess Efficacy and Safety of Bone Marrow Derived Stem Cells in Patients With Critical Limb Ischemia
This study will assess the safety and efficacy of intra-arterial infusion and intramuscular injection of an autologous, bone marrow-derived stem cell preparation (ASCT01) in patients with critical limb ischemia who have exhausted…
- Trial name
- CLI (NCT01867190)
- Testing
- ASCT01 (Autologous Stem Cell Transplantation)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Lifecells, LLC.
Critical Limb Ischemia
Autologous Stem Cells for the Treatment of No Option Critical Limb Ischemia
The trial is a phase 1b, open label, uncontrolled, non-randomized dose-escalation study of autologous bone marrow-derived MSCs. Following informed consent, patients who meet the criteria will be screened and enrolled.
- Trial name
- NCT03455335
- Testing
- 20 million hMSCs, 40 million hMSCs, 80 million hMSCs
- Where
- Ireland
- Volunteers
- 12 people
- Sponsor
- National University of Ireland, Galway, Ireland
Critical Limb Ischemia Due to Buerger's Disease
A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease
This study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued clinical study in consultation with ICMR, as per recommendation of…
- Trial name
- NCT03056742
- Testing
- Stempeucel(R)
- Where
- 8 sites in India
- Sponsor
- Stempeutics Research Pvt Ltd
Peripheral Arterial Occlusive Disease, Critical Limb Ischemia
Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD/CLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)
The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of [89Zr]Zr-DFO-APAC in patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and healthy volunteers.
- Trial name
- CHASE (NCT06204237)
- Testing
- [89Zr]Zr-DFO-APAC, PET/CT scan
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Aplagon Oy
Critical Limb Ischemia
Mesenchymal Stem Cells in Critical Limb Ischemia
This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.
- Trial name
- NCT00883870
- Testing
- mesenchymal stem cells, Plasmalyte A
- Where
- 4 sites in India
- Volunteers
- 20 people
- Sponsor
- Stempeutics Research Pvt Ltd
Critical Limb Ischemia
Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia
Percutaneous transluminal angioplasty (PTA) of infra-popliteal arteries in patients suffering peripheral arterial occlusive disease (PAOD) provides good results in terms of limb salvage.
- Trial name
- NCT02498080
- Testing
- DEB PTA, Standard PTA
- Volunteers
- 60 people
- Sponsor
- Neuromed IRCCS
Chronic Limb-Threatening Ischemia, Diabetic Foot Ulcer
Seltoplasmid Plus Revascularization for Diabetic Infrapopliteal Chronic Limb-Threatening Ischemia
The goal of this clinical trial is to learn whether Seltoplasmid Injection can improve outcomes after lower-extremity revascularization. Revascularization is a procedure used to restore blood flow to the leg.
- Conditions
- Chronic Limb-Threatening Ischemia, Diabetic Foot Ulcer, Infrapopliteal Arterial Occlusive Disease
- Trial name
- NCT07827521
- Testing
- Lower-Extremity Revascularization, Donaperminogene Seltoplasmid
- Where
- 6 sites in China
- Volunteers
- 180 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
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
Critical Limb Ischemia
Investigating the Safety and Efficacy of the Treatment With Luminor DCB and Angiolite DES of iVascular in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia
This study aims to evaluate the 12 month outcome of the mono- or combination therapy with iVascular Luminor DCB and Angiolite DES for treatment of TASC C and TASC D long tibial occlusive disease, presenting with critical limb…
- Trial name
- MERLION (NCT04073121)
- Testing
- Luminor DCB and Angiolite DES
- Where
- 2 sites in Singapore
- Volunteers
- 50 people
- Sponsor
- Singapore General Hospital
Chronic Limb-Threatening Ischemia
Validating GLASS Score in Predicting Acute Limb Events in CLTI Patients
Ischemia is a severe medical condition that occurs when the blood and oxygen supply to a specific part of the body is significantly reduced or completely absent, it can affect any body part, often the legs.
- Trial name
- PROMOTEGLASS (NCT06186544)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Cardiff and Vale University Health Board
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
Peripheral Arterial Disease, Critical Limb Ischemia
Serranator Recoil Study
The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as…
- Trial name
- NCT05161039
- Testing
- Serranator, POBA
- Where
- 2 sites in United States, Germany
- Volunteers
- 20 people
- Sponsor
- Cagent Vascular LLC
Critical Limb Ischemia
Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for…
- Trial name
- NCT02099500
- Testing
- Liposuction, Stem Cell Injection
- Where
- United States
- Sponsor
- Ageless Regenerative Institute
Chronic Limb Threatening Ischemia
Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection with Borderline Vascularity
Observe Timing to complete healing of wounds \& Limb salvage in both cohorts those who are undergoing Debridement only and those who are undergoing Debridement plus PTA
- Trial name
- NCT05553509
- Testing
- PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Assiut University
Peripheral Arterial Disease, Critical Limb Ischemia
Leg Ischaemia Management Collaboration
Single-centre prospective cohort study of patients presenting with severe limb ischaemia (SLI). The primary outcome measure will be 12 month major amputation rate.
- Conditions
- Peripheral Arterial Disease, Critical Limb Ischemia, Frailty, Cognitive Impairment
- Trial name
- LIMb (NCT04027244)
- Where
- United Kingdom
- Volunteers
- 420 people
- Sponsor
- University of Leicester
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia
RESCUE is a Europe-wide study that will follow 400 people with critical limb-threatening ischemia (CLTI). It aims to see how well Esprit BTK™ Everolimus Eluting Resorbable Scaffolds work in real-life medical settings.
- Trial name
- RESCUE (NCT07270575)
- Testing
- Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Critical Limb Ischemia
Efficacy and Safety of Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia
This clinical trial is designed as a Phase 1/2a clinical trial targeting patients with critical limb ischemia. The trial is composed of Phase 1 to assess the tolerability and safety and Phase 2a to assess the safety and efficacy…
- Trial name
- NCT04661644
- Testing
- Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial), Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^8 cells/1 mL/vial)
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- S.Biomedics Co., Ltd.
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
Critical Limb Ischemia (CLI)
Clinical Trial I/II Opened, Randomized and Controlled for the Study of the Use of Stem Cells Therapy in Insulinized Diabetic Patients Type 2 With Critical Ischemia in Lower Limbs (CLI): Study of the Needs of Insulin
To study the effect of the stem cells therapy autologous mononuclear from the bone marrow, autologous progenitor endothelial CD133 cells from the bone marrow and autologous mesenchymal stem cells from adipose tissue on the…
- Trial name
- NCT02287974
- Testing
- Stem cell infusion
- Where
- 2 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud