Clinical trials: Chronic Limb-threatening Ischemia
Limb Ischemia, Diabetic Foot
Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia
Phase II national, multicenter, double-blind, randomized, placebo-controlled, phase-3 clinical trial of 3 parallel groups.
- Trial name
- NCT04466007
- Testing
- High dose allogeneic mesenchymal stromal cells, Low dose allogeneic mesenchymal stromal cells
- Where
- 10 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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
Chronic Threatening Lower Limb Ischemia
Duplex Ultrasound Versus Conventional Angiography in Evaluating Lower Limb Threatening Ischemia
This study aims to evaluate the accuracy of Duplex Ultrasound (DUS) in assessing infra inguinal arterial lesions in patients with chronic threatening limb ischemia compared with digital subtraction angiography (DSA) as the…
- Trial name
- DUS-CTA (NCT07113197)
- Testing
- conventional angiography
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Sohag University
Critical Limb Ischemia
Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.
To evaluate the safety and effectiveness of the Spur System in a patient population with infrapopliteal artery disease (tibioperoneal, anterior/posterior tibial and peritoneal arteries) when used in conjunction with…
- Trial name
- DEEPER (NCT03669458)
- Testing
- Below the Knee peripheral intervention
- Where
- Dominican Republic
- Volunteers
- 21 people
- Sponsor
- ReFlow Medical, Inc.
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.
Chronic Limb Threatening Ischemia
Outcomes of Atherectomy and Balloon Angioplasty Compared to Conventional Angioplasty in Infra-popliteal Chronic Limb-Threatening Ischemia
Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral artery disease (PAD), characterized by rest pain, non-healing ulcers, or gangrene, and is associated with high morbidity and risk of…
- Trial name
- NCT07120555
- Testing
- atherectomy, Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Assiut University
Angioplasty, Anaesthesia and Analgesia
Popliteal Block for Lower Limb Angioplasty
Endovascular revascularization is an effective procedure in treatment of chronic critical limb ischemia. The less invasive procedure in high risk patients produce the benefit to the patients.
- Trial name
- NCT04445480
- Testing
- Popliteal block, Control
- Where
- Thailand
- Volunteers
- 40 people
- Sponsor
- Mahidol University
Lower Limb, Ischemia
Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia
This study evaluates the clinical effectiveness of Magnetic Resonance(MR) perfusion imaging to qualitatively assess adequate distal perfusion after endovascular revascularization in Critical Limb Ischemia
- Conditions
- Lower Limb, Ischemia, Perfusion
- Trial name
- MR CLI (NCT02646150)
- Testing
- Magnetic Resonance Perfusion Imaging
- Where
- South Korea
- Volunteers
- 65 people
- Sponsor
- Seung-Whan Lee, M.D., Ph.D.
Critical Lower Limb Ischemia
Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia
The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.
- Trial name
- NCT04490408
- Testing
- long surgical bypass, Hybrid approach
- Volunteers
- 52 people
- Sponsor
- Egyptian Biomedical Research Network
Ischemia Lesions
Polytetrafluoroethylen (PTFE) Vascular Prostheses With Heparin Bonded Luminal Surfaces vs Crude ePTFE
Open repair could be recommended in a first line of treatment to revascularize critical limb ischemia patients or performed in a second line of treatment in case of failure of endovascular repair.
- Trial name
- REPLACE (NCT03430076)
- Testing
- revascularization, Propaten®, Crude PTFE
- Where
- 21 sites in France
- Volunteers
- 228 people
- Sponsor
- Nantes University Hospital
Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication
Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
Acute compartment syndrome (ACS) is a surgical emergency that can develop in patients on extracorporeal membrane oxygenation (ECMO).
- Conditions
- Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication, Limb Ischemia, Limb Ischemia, Critical
- Trial name
- VA-ECMO (NCT05830721)
- Testing
- MY01 + Standard of Care, 14-Gauge Slit Catheter + Standard of Care, Standard of Care
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Johns Hopkins University
Peripheral Artery Disease
Cardiovascular Biomarkers in Peripheral Artery Disease.
Despite the best medical management, many patients with peripheral artery disease (PAD) who undergo lower extremity endovascular revascularization experience adverse cardiovascular outcomes and postoperative complications that…
- Trial name
- NCT05757258
- Where
- Italy
- Volunteers
- 207 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Chronic Limb-Threatening Ischemia
Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment
Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment
- Trial name
- Tevi-LuSy (NCT06111599)
- Testing
- lumbar sympathetic blockade
- Where
- Slovakia
- Volunteers
- 60 people
- Sponsor
- EPC Education s.r.o.
Critical Limb Ischemia
New Oxymetry Indices in Critical Limb Ischemia
Transcutaneous oxygen tension (TcpO2) at rest, sensitized by oxygen inhalation tests, is widely applied for the evaluation of chronic critical limb ischemia (CLI).
- Trial name
- NOVICE (NCT04209998)
- Testing
- transcutaneous oximetry
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Angers
Peripheral Artery Disease, Critical Limb Ischemia
Complete Lesion Assessment With ffR and IVUS TechnologY
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
- Trial name
- CLARITY I (NCT01941030)
- Testing
- Orbital Atherectomy System, Balloon Angioplasty
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive…
- Trial name
- NCT03124875
- Testing
- LimFlow System
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- LimFlow, Inc.
Peripheral Vascular Diseases
DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia
The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective …
- Trial name
- NCT02750605
- Testing
- DEB, POBA
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Skane University Hospital
Chronic Limb-Threatening Ischemia
High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia
The study of high-frequency spinal cord stimulation (SCS) efficacy in the treatment of chronic limb-threatening ischemia (CLTI)
- Trial name
- HEAL-SCS (NCT05322798)
- Testing
- High-frequency SCS, Low-frequency SCS
- Where
- Russia
- Volunteers
- 25 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Arterial Occlusive Diseases, Vascular Diseases
Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery
Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass.
- Trial name
- SPACIAL (NCT01147419)
- Testing
- stent, femoral-popliteal bypass with artificial blood vessel
- Where
- 3 sites in China
- Volunteers
- 200 people
- Sponsor
- Peking Union Medical College Hospital
Leg Ulcer, Diabetic Foot
Autologous Transplantation of BM-ECs With Platelet-Rich Plasma Extract for the Treatment of Critical Limb Ischemia
The intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE) for the treatment of critical limb…
- Conditions
- Leg Ulcer, Diabetic Foot, Gangrene, Peripheral Vascular Disease
- Trial name
- NCT02993809
- Testing
- BM-ECs and PRPE, BM-ECs
- Volunteers
- 40 people
- Sponsor
- South China Research Center for Stem Cell and Regenerative Medicine