Clinical trials: Critical Limb Ischemia, open to volunteers
Critical Limb Ischemia
miRNAs in Critical Limb Ischemia (miRNACLI)
For the present study, 40 patients affected by critical limb ischemia of different severity will be enrolled: patients affected by critical limb ischemia undergoing subgenual femoropopliteal bypass; patients suffering from…
- Trial name
- miRNACLI (NCT06066268)
- Testing
- Critical limb ischemia: analysis of RNAs, Controls: analysis of RNAs
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- IRCCS Policlinico S. Donato
Femoropopliteal Disease, Drug Coated Balloon
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
The aim of this clinical trial is to determine whether vessel preparation with a non-compliant scoring balloon before drug-coated balloon (DCB) angioplasty provides superior procedural and clinical outcomes compared with vessel…
- Conditions
- Femoropopliteal Disease, Drug Coated Balloon, Critical Limb-Threatening Ischaemia, Peripheral Arterial Disease
- Trial name
- DASBAD-NC (NCT07764016)
- Testing
- Non-compliant Plain Balloon angioplasty (PBA), Non-compliant Scoring Balloon Angioplasty (SB)
- Volunteers
- 142 people
- Sponsor
- Marc Sirvent
Critical Limb Ischemia, Malnutrition
Nutrition in Patient With Critical Limb Ischemia
A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the potential to benefit greatly from…
- Conditions
- Critical Limb Ischemia, Malnutrition, Nutritional Supplements
- Trial name
- NutriVasc (NCT03529019)
- Testing
- Ensure Surgery Immunonutrition Shake, Ensure Enlive Advanced Nutrition Shake
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Boston Medical Center
Femoral Arterial Calcification, Peripheral Arterial Disease
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of…
- Conditions
- Femoral Arterial Calcification, Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT05145478
- Testing
- Shockwave Intravascular Lithotripsy (IVL)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Yale University
Peripheral Arterial Disease, Critical Limb Ischemia
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.
- Conditions
- Peripheral Arterial Disease, Critical Limb Ischemia, Critical Lower Limb Ischemia
- Trial name
- TIC (NCT06544135)
- Testing
- FLIR One Pro LT
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- University Hospitals Cleveland Medical Center
Critical Ischemia Limb
NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia
Peripheral arteriopathy disease (PAD) affects 1 million people in France. In its most advanced stage: chronic permanent ischemia also called critical ischemia, the prognosis of patients is burdened with a one-year mortality rate…
- Trial name
- NOBILIS (NCT06238050)
- Testing
- introduction of oxygen therapy or not
- Where
- 3 sites in France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Angers
Major Adverse Limb Events, Major Adverse Cardiovascular Events
Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage
Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades.
- Conditions
- Major Adverse Limb Events, Major Adverse Cardiovascular Events, Peripheral Artery Disease, Critical Limb Ischemia
- Trial name
- TAMIS (NCT06318767)
- Testing
- hemodynamic measure of the Systolic Time Rise
- Where
- France
- Volunteers
- 134 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Critical Limb Ischemia
FAZA PET/MRI in CLI Patients Pre and Post Revascularization
Peripheral artery disease is a worldwide problem, leading to high mortality and mobility. Critical limb ischemia (CLI) is associated with high risk of amputation with the subsequent decreased in life quality.
- Trial name
- NCT04054609
- Testing
- FAZA PET/MRI scan
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University Health Network, Toronto
Stable Coronary Artery Disease, Acute Coronary Syndromes
Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease
Numerous clinical studies have highlighted the role of macrophages in the destabilization of coronary lesions; however, there is limited literature on the relationship between circulating monocytes and intraplaque macrophages.
- Conditions
- Stable Coronary Artery Disease, Acute Coronary Syndromes, Critical Limb Ischemia, Intermittent Claudication
- Trial name
- NCT07588295
- Testing
- Optical Coherence Tomography assessment
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Maria Cecilia Hospital
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
- Conditions
- Critical Limb Ischemia, Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
- Trial name
- NCT05313165
- Testing
- LimFlow Stent Graft System
- Where
- 30 sites in United States
- Volunteers
- 100 people
- Sponsor
- LimFlow, Inc.
Peripheral Arterial Disease, Critical Limb-Threatening Ischemia
Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia
The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI.
- Conditions
- Peripheral Arterial Disease, Critical Limb-Threatening Ischemia, Diabetic Foot
- Trial name
- PiPER (NCT06277362)
- Where
- 9 sites in Italy
- Volunteers
- 50 people
- Sponsor
- EndoCore Lab s.r.l.
Peripheral Artery Disease (PAD), Femoropopliteal Artery Disease
Chocolate Balloon vs Standard Balloon Angioplasty Before Drug-Coated Balloon Treatment for Femoropopliteal Artery Narrowing or Blockage
The goal of this clinical trial is to learn if using the Chocolate Percutaneous Transluminal Angioplasty (PTA) balloon for vessel preparation improves outcomes before drug-coated balloon (DCB) treatment in patients with…
- Conditions
- Peripheral Artery Disease (PAD), Femoropopliteal Artery Disease, Vascular Lesion Preparation, Critical Limb-Threatening Ischemia
- Trial name
- CHOICE (NCT07471087)
- Testing
- Chocolate PTA Balloon, Standard Balloon Angioplasty (POBA)
- Volunteers
- 242 people
- Sponsor
- Felice Pecoraro
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.
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
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
Critical Limb Ischemia, Peripheral Arterial Disease
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial 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 peripheral…
- Trial name
- NCT05854641
- Testing
- Stempeucel®
- Where
- Malaysia
- Volunteers
- 10 people
- Sponsor
- Cell Biopeutics Resources Sdn Bhd
Peripheral Artery Disease, Critical Limb Ischemia
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major amputation, clinically driven target lesion…
- Trial name
- TANGO-3 (NCT04433572)
- Testing
- Temsirolimus
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- Mercator MedSystems, Inc.
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase…
- Conditions
- Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans
- Trial name
- NCT07023965
- Testing
- NL003
- Where
- 5 sites in China
- Volunteers
- 542 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
Peripheral Arterial Disease, Critical Limb Ischemia (CLI)
Pressure (Fractional Flow Reserve) and Flow (Vascular Flow Reserve) Measurements During Peripheral Arterial Interventions
Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) have been originally developed for physiological assessment of coronary artery disease and may hold potential in the management of Peripheral Arterial Disease (PAD) as…
- Trial name
- FLOW-PAD (NCT07052435)
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- Dr. Konstantinos Katsanos