Clinical trials: Chronic Limb-threatening Ischemia
Chronic Limb-Threatening Ischemia
Agreement Study on AI-assisted Smartphone-based Monitoring Tool for Difficult-to-heal Ischemic Leg Ulcers
The purpose of the project is to investigate the agreement with Bland-Altman plots between an AI-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with…
- Trial name
- NCT06421961
- Where
- Sweden
- Volunteers
- 223 people
- Sponsor
- Sahlgrenska University Hospital
Angioplasty, Critical Lower Limb Ischemia
Outcomes of Straight-line Flow Versus Angiosome-targeted Angioplasty in Treatment of Critical Lower Limb Ischemia
Peripheral arterial disease (PAD) affects more than 200 million people worldwide. Although over 50% are asymptomatic, it accounts for 4% of all amputations.
- Trial name
- NCT06127134
- Testing
- peripheral angioplasty for tibial vessels
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Kafrelsheikh University
Critical Limb Ischemia, Peripheral Vascular Disease
Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
The purpose of this research study is to determine if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in the severely diseased…
- Trial name
- mesendo (NCT00518401)
- Testing
- Mesendo
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- TCA Cellular Therapy
Peripheral Arterial Disease, Claudication
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.
- Conditions
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT00883246
- Testing
- SilverHawk & TurboHawk Peripheral Plaque Excision System
- Volunteers
- 800 people
- Sponsor
- Medtronic Endovascular
Critical Limb Ischemia, Peripheral Artery Disease
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.
- Trial name
- NCT04304105
- Where
- 25 sites in United States, Puerto Rico
- Volunteers
- 192 people
- Sponsor
- LimFlow, Inc.
Critical Limb Ischemia, Peripheral Artery Disease
Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
The aim of this observational study is to evaluate the outcomes and safety of the Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease (PAD) in below-the-knee vessels
- Trial name
- Apollo (NCT02539940)
- Testing
- Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV
- Where
- 10 sites in Germany
- Volunteers
- 166 people
- Sponsor
- Jena University Hospital
Limb Ischemia, Critical
Role and Outcome of Endovascular Revascularization of Chronic Limb Ischaemia
identify the safety and efficacy of percutaneous transluminal angioplasty in critical limb ischaemia patients with chronic kidney dieases
- Trial name
- NCT05643378
- Volunteers
- 100 people
- Sponsor
- Mahmoud Abdelmohsen Mostafa Osman
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
Critical Limb Ischemia
Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia
The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA.
- Trial name
- DEEPER RCT (NCT06122974)
- Testing
- Drug Eluting Temporary Spur Stent System, Percutaneous Transluminal Balloon Angioplasty
- Volunteers
- 518 people
- Sponsor
- ReFlow Medical, Inc.
Peripheral Artery Disease, Peripheral Vascular Disease
Safety of Intramuscular Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia
The The purpose of this study is to determine the safety of PLX-PAD single dose, Intra-muscular injection for the treatment of CLI patients.
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00919958
- Testing
- PLX-PAD IM injection
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Pluristem Ltd.
Critical Limb Ischemia
Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy
The clinical trial aims to study the safety and efficacy of adult allogeneic mesenchymal stem cells for the treatment of critical limb ischemia.
- Trial name
- NCT03239535
- Testing
- Mesenchymal stem cells, Normal saline
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
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
Chronic Limb-Threatening Ischemia
Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural…
- Trial name
- CALCIO (NCT06149650)
- Testing
- Shockwave Medical IVL System
- Where
- 39 sites in Austria, Canada and 6 more
- Volunteers
- 400 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Peripheral Arterial Disease
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
The main aim of the present study was to evaluate the therapeutic potential and safety of transarterial infusion of granulocyte colony stimulating factor (G-CSF) mobilized cluster of differentiation (CD) 133(+) cells when…
- Trial name
- NCT02915796
- Testing
- G-CSF + CD133(+) cells, G-CSF, percutaneous transluminal angioplasty (PTA)
- Where
- China
- Volunteers
- 345 people
- Sponsor
- Shanghai 10th People's Hospital
Critical Limb Ischemia
Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure
In chronic CLI patients who are appropriate candidates for endovascular procedures - and many patients are not because of their advanced age and disease state - the treatment regimen may include endovascular procedures such as…
- Trial name
- NCT00651885
- Testing
- treprostinil dienthanolmine sustained release
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Ochsner Health System
Leg Pain, Ulcer
Stem Cell Study for Patients With Leg Ulcer/Gangrene
The purpose of this study is to determine if stem cell therapy with one's own cells (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve…
- Conditions
- Leg Pain, Ulcer, Gangrene, Ischemia
- Trial name
- NCT00221143
- Testing
- Autologous peripheral blood CD34 positive cell therapy
- Where
- 2 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries
LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Arterial Occlusive Diseases
- Trial name
- LEGDEB2 (NCT04175197)
- Testing
- Drug Coated Balloon
- Where
- 7 sites in Italy, Mexico
- Volunteers
- 512 people
- Sponsor
- Federico II University
Critical Limb Ischemia
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation
Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon…
- Trial name
- DEBATE-BTK (NCT01558505)
- Testing
- PEB, POBA
- Where
- Italy
- Volunteers
- 142 people
- Sponsor
- Leonardo Bolognese, MD
Peripheral Arterial Disease, Arterial Occlusive Diseases
Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery
The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
- Conditions
- Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, Arteriosclerosis
- Trial name
- PAVENST (NCT02212470)
- Testing
- Drug Eluting Balloon Angioplasty, Nitinol stenting
- Where
- Brazil
- Volunteers
- 85 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Critical Limb Ischemia
Peri-operative Foot CT Perfusion in CLI Patients
To investigate the clinical value of quantitative analysis of peri-operative foot supply through CT perfusion in patients with critical limb ischemia
- Trial name
- POP-CLI (NCT05575778)
- Testing
- computed tomographic perfusion
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Fudan University