Clinical trials: Critical Ischemia
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
Critical Ischemia
STREAMER : STent Restenosis And MEdicaments Release
It is a pilot study to evaluate the feasibility and the efficiency of local delivery of paclitaxel after stenting of long femoropopliteal arterial lesions TASC C and D before the realization of a large randomized multicentric…
- Trial name
- STREAMER (NCT02835586)
- Testing
- Paclitaxel
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Hospices Civils de Lyon
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
Shock, Aortic Valve Disease
Non-invasive Prediction of Fluid and Noradrenaline Responsiveness Using the Carotid Wave Intensity.
The goal of this observational study is to study a new method to compute ventricular-arterial coupling (VAC) in adult intensive care patients after cardiac surgery.
- Conditions
- Shock, Aortic Valve Disease, Coronary Artery Disease, Mitral Valve Disease
- Trial name
- VACC (NCT06197321)
- Where
- Netherlands
- Volunteers
- 120 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
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
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
Correlation Between FlowMet™ and Other Gold Standard Assessments in the Management of Critical Limb Ischemia (CLI)
The purpose of this study is to demonstrate the utility of the FlowMet™ device in the assessment of perfusion in subjects suspected of or being treated for critical limb ischemia, in comparison to other gold standard…
- Trial name
- NCT03094559
- Testing
- FlowMet
- Where
- United States
- Sponsor
- The Cleveland Clinic
Critical Limb Ischemia
External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality
In this clinical research study the investigators will test the efficacy of an innovative, non-invasive methodology to reduce mortality and lower limb loss among high-risk medically-underserved patients with cardiovascular…
- Trial name
- ArtAssist (NCT02054416)
- Testing
- ArtAssist© Device
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Temple University
Myocardial Ischemia, Critical Illness
Bright Light Exposure in Surgical Patients
1. Elucidate the influence of intense light therapy pretreatment in patients undergoing cardiac surgery. We hypothesize that intense light exposure is associated with the peripheral stabilization of Per2 in human buccal swabs and…
- Conditions
- Myocardial Ischemia, Critical Illness, Endothelial Dysfunction
- Trial name
- NCT03822949
- Testing
- Day Light, ICU Intense Light
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of Colorado, Denver
Critical Limb Ischemia
Registry of First-line Treatments in Patients With Critical Limb Ischemia
The principal research question is which treatment modality between open surgical, endovascular and conservative therapy is the most effective in terms of limb salvage, survival and reinterventions in patients with critical limb…
- Trial name
- CRITISCH (NCT01877252)
- Testing
- Surgical revascularization, Endovascular revascularization, No vascular intervention
- Where
- Germany
- Volunteers
- 1,200 people
- Sponsor
- St. Franziskus Hospital
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.
Drug Coated Balloon
Drug Coated Ballon in Critical Limb Ischemia
Evaluate the safety and efficacy of drug coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with critical limb ischemia (CLI)
- Trial name
- DCB (NCT04737291)
- Testing
- drug coated balloon
- Volunteers
- 36 people
- Sponsor
- Assiut University
Critical Limb Ischemia, Drug Effect
Comparison of Sirolimus vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia
The objective of this study is to compare the remote patency of paclitaxel versus sirolimus eluting balloons in patients with CLI undergoing tibial artery revascularization.
- Trial name
- DebateBTKDuell (NCT04594889)
- Testing
- angioplasty
- Where
- Italy
- Volunteers
- 170 people
- Sponsor
- Ospedale San Donato
Peripheral Vascular Disease
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation.
- Trial name
- NCT00300040
- Testing
- Hemoglobin glutamer 250 - bovine, 6% Hydroxyethylstarch
- Where
- 5 sites in South Africa, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Biopure Corporation
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
Critical Limb Ischemia, Peripheral Arterial Disease
Revascularization of Stenosed Vessels Using Optimized Treatment of Rejuveinix for Reversing Endothelial Dysfunction
A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of Rejuveinix in Combination With Standard Interventional Therapy for Critical Limb Ischemia Patients with Rutherford Class 4, 5 and 6 Disease
- Trial name
- RESTORE (NCT03041259)
- Testing
- Rejuveinix Low Dose, Rejuveinix High Dose
- Volunteers
- 320 people
- Sponsor
- Reven Pharmaceuticals, Inc.
Critical Limb Ischemia
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
- Trial name
- NCT02046226
- Testing
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Halyard Health
Peripheral Arterial Disease, Diabetes Mellitus
Cell Therapy for Peripheral Arterial Disease and Diabetes
This is a randomized controlled trial with blinding (for the observer who evaluates treatment goals). With two groups to study. A group of patients with conventional therapy for the treatment of PAD (Platelet antiaggregant…
- Trial name
- NCT03635970
- Testing
- celular therapy
- Where
- Mexico
- Volunteers
- 24 people
- Sponsor
- Hospital Regional de Alta Especialidad del Bajio
Critical Limb Threatening Ischaemia, Depression Disorder
Symptoms of Anxiety and/or Depression and SDM in Older Patients With CLTI
Mental health disorders are common in older people and are often unrecognised. Those living with mental health disorders who are being considered for vascular surgery have worse post operative outcomes, including longer length of…
- Conditions
- Critical Limb Threatening Ischaemia, Depression Disorder, Anxiety
- Trial name
- NCT07529886
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Cardiac Disease, Cardiac Ischemia
Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit
The objective of this study is to investigate the incidence of death and early postoperative complications, identify potential risk factors, and examine the demographic characteristics of patients and epidemiology of…
- Conditions
- Cardiac Disease, Cardiac Ischemia, Cardiac Valve Disease
- Trial name
- BraSIS-2 (NCT06154473)
- Testing
- Open heart surgery group., Percutaneous cardiovascular surgery group.
- Where
- Brazil
- Volunteers
- 528 people
- Sponsor
- Hospital Israelita Albert Einstein