Clinical trials: Critical Ischemia
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
The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve will improve systemic inflammation and patency of peripheral vascular intervention (PVI).
- Trial name
- OMEGA-PVI (NCT02096757)
- Testing
- Pro-Omega
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of California, San Francisco
Peripheral Artery Disease, Critical Limb Ischemia
Imaging-Guided Vessel Sizing in the Tibial Arteries
This study aims to investigate the utilization of intravascular imaging in treatment of tibial vessels in peripheral artery disease and critical limb ischemia (CLI).
- Trial name
- iVEST (NCT04748965)
- Testing
- Digital Subtraction Angiography
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
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
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
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
Cardiogenic Shock
PRecision Ecmo in CardIogenic Shock Evaluation
Venoarterial (VA) ECMO is a form of life support for patients with severe cardiogenic shock and cardiac arrest. Although it can be lifesaving, currently many patients still die or have long term disability, such as weakness…
- Trial name
- PRECISE (NCT05748860)
- Volunteers
- 236 people
- Sponsor
- Australian and New Zealand Intensive Care Research Centre
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.
Peripheral Artery Disease, Critical Limb Ischemia
Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
The purpose of this study is to evaluate the effectiveness of negative pressure incision management system (Prevena™ Incision Management System (PIMS) or ActiVAC® with the Prevena™ Dressings (Peel and Place™ or Customizable™)…
- Conditions
- Peripheral Artery Disease, Critical Limb Ischemia, Claudication
- Trial name
- NCT02389023
- Testing
- standard gauze dressing, Prevena Incision Management system
- Where
- 5 sites in United States
- Volunteers
- 242 people
- Sponsor
- University of Vermont Medical Center
Peripheral Arterial Disease
Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia
This study is designed to evaluate the safety and efficacy of autologous Vascular Repair Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb ischemia.
- Trial name
- RESTORE-CLI (NCT00468000)
- Testing
- Ixmyelocel-T
- Where
- 20 sites in United States
- Volunteers
- 86 people
- Sponsor
- Vericel Corporation
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
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
Atherosclerosis, Peripheral Artery Disease
The ABSORB BTK (Below The Knee) Clinical Investigation
The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with critical limb ischemia (CLI) following…
- Conditions
- Atherosclerosis, Peripheral Artery Disease, Peripheral Vascular Disease, PAD
- Trial name
- NCT01341340
- Testing
- Everolimus Eluting BVS
- Where
- Belgium
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia
ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice.
- Trial name
- ORACLE (NCT07270562)
- Testing
- Stealth 360™ Peripheral Orbital Atherectomy System from Abbott
- Where
- United Kingdom
- Volunteers
- 250 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Chronic Limb-threatening Ischemia, Endovascular Therapy
Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With Wound, Ischemia, and Foot Infection (WIFI) Assessment
This is a prospective multicenter clinical study that used WIFI grading scores at different periods to evaluate the therapeutic value of endovascular therapy and this grading system for Chronic limb-threatening ischemia.
- Trial name
- NCT04710420
- Testing
- Endovascular therapy
- Where
- China
- Volunteers
- 842 people
- Sponsor
- Xuanwu Hospital, Beijing
Intermittent Claudication, Critical Limb Ischemia
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)
This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.
- Trial name
- NCT00300690
- Testing
- 6 mm Uni-graft® (B-Braun), 6 mm Gore-Tex® (WL Gore)
- Volunteers
- 400 people
- Sponsor
- University Hospital, Gentofte, Copenhagen
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
Myocardial Infarction, Stroke
Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill
Patients are admitted to the critical care unit of the hospital because of medical conditions that have a high likelihood of causing severe problems with blood flow, breathing, or brain function.
- Conditions
- Myocardial Infarction, Stroke, Renal Failure
- Trial name
- VASTVALUS (NCT01073800)
- Testing
- atorvastatin 80 mg per os daily
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- University of Alberta
Ischemia
Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries…
- Trial name
- NCT02758847
- Testing
- Angiogram, Medtronic DCB (paclitaxel)/stent, Angiogram, Bard DCB (paclitaxel)/stent
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Rabih A. Chaer
Critical Limb Ischemia and Peripheral Artery Disease
Administration of Adipose-derived Stem Cells (ASC) in Patient With Critical Limb Ischemia.
Different types of stem cells have recently been studied in clinical trial on ischemic disease of the heart and muscular arteries.
- Trial name
- ACellDREAM2 (NCT03968198)
- Testing
- Autologous ASC (for Adipose-derived Stem/Stroma Cell)
- Where
- France
- Volunteers
- 2 people
- Sponsor
- University Hospital, Toulouse