Clinical trials: Critical Ischemia Limb
Critical Limb Ischemia, Peripheral Artery Disease
Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair
The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the…
- Trial name
- NCT02044003
- Testing
- Innovasc Tack Intravascular Staple System (Tack)
- Where
- 2 sites in Paraguay
- Volunteers
- 11 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Critical Limb Ischemia, Claudication, Intermittent
Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
To identify a correlation between Toe Brachial pressure Index (TBPI) and Acceleration time of the pedal vessels. The aim would then to use this data to design a clinical study assessing the relationship between PAT and wound…
- Trial name
- PAT (NCT06007469)
- Volunteers
- 50 people
- Sponsor
- Liverpool University Hospitals NHS Foundation Trust
Critical Limb Ischemia
Autologous Angiogenic Cell Precursors (ACPs) for the Treatment of Peripheral Artery Disease
Regeneration of the occluded peripheral arteries by autologous stem cell therapy is an emerging treatment modality for no-option patients with peripheral artery disease (PAD).
- Trial name
- NCT01584986
- Testing
- ACP injections
- Where
- 2 sites in Hungary
- Volunteers
- 22 people
- Sponsor
- Salus Ltd.
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
Critical Limb Ischemia, Diabetes
Trial to Assess Chelation Therapy in Critical Limb Ischemia
TACT3a is a double blind, placebo-controlled, randomized trial to test a novel therapy, edetate disodium-based chelation of environmentally acquired toxic metals, to reduce cardiovascular events including amputation in high-risk…
- Trial name
- TACT3a (NCT03982693)
- Testing
- Edetate Disodium
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mt. Sinai Medical Center, Miami
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
Venous Allogeneic Transplant, Occlusive Peripheral Arterial Disease
Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C (ERAV)
The main objective of this study is to assess the 2-year survival with salvage of the lower limb of patients who have undergone subgonal bypass grafting by venous allograft in the treatment of Occlusive Peripheral Arterial…
- Trial name
- ERAV (NCT05101512)
- Testing
- Questionnaires on quality of life after surgery
- Where
- France
- Volunteers
- 150 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
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
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
Critical Limb Ischemia, Peripheral Arterial Disease
Evaluation of Post-Angioplasty Outcomes
There is no hard and fast rule guiding the clinical decision between angioplasty and amputation. As such, this decision is greatly dependant on each clinician's experience and preference as to whether treatment should be…
- Trial name
- NCT05018949
- Testing
- Lower limb angioplasty
- Where
- Singapore
- Volunteers
- 1,000 people
- Sponsor
- Singapore General Hospital
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
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
Peripheral Arterial Disease
Use of Indocyanine Green Angiography in Critical Limb Ischemia
Investigators conduct a monocentric pilot study with the objective to determine the hemodynamic parameter of fluorescence angiography (slope, amplitude, saturation time ) best correlated with toe pressure in patients with…
- Trial name
- FLUORESCENCE (NCT02820467)
- Testing
- fluorescence angiography
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Grenoble
Critical Limb Ischemia
Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI)
Critical limb ischemia (CLI), is the most severe form of peripheral arterial disease (PAD), and clinically is characterized by pain at rest or non-healing ulcers of the lower extremities.
- Trial name
- Evol-CLI (NCT04306471)
- Testing
- Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months.
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Leonardo Clavijo
Critical Limb Ischemia
Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia
The purpose of this study is to evaluate the safety and efficacy of the concentrated autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia patients.
- Trial name
- NCT01472289
- Testing
- Autologous Bone Marrow Mononuclear cells (BMMNCs)
- Where
- India
- Volunteers
- 17 people
- Sponsor
- TotipotentSC Scientific Product Pvt. Ltd.
Chronic Limb Threatening Ischemia
Vessel Recoil in Specific CLTI Populations
Chronic limb threatening ischemia (CLTI) represents the most advanced stage of peripheral arterial disease (PAD) and is characterized by ischemic rest pain, non-healing wounds, or ischemic gangrene.
- Trial name
- NCT07465627
- Testing
- Vessel recoil measurement 15 minutes post final treatment (angiographically)
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Medical University of Graz
Peripheral Arterial Disease
Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia
Near-infrared spectroscopy can be used to determine the relative oxygen saturation in tissues up to 2cm below the skin. It has been investigated, with success, in cerebral, gastrointestinal, and muscle tissue, and shows promise…
- Trial name
- NCT00224328
- Testing
- ODISsey Tissue Oximeter
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- ViOptix Canada
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
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
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)
Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic stem/progenitor cells (HSPC) (BGC101), in the…
- Conditions
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- EnEPC-CLI (NCT02805023)
- Testing
- BGC101 (autologous EnEPC preparation), Control medium
- Where
- 5 sites in United States, Israel
- Volunteers
- 40 people
- Sponsor
- BioGenCell Ltd.