Clinical trials: Critical Ischemia
Peripheral Arterial Disease, Critical Limb Ischemia
A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base DCB
This is a non-randomized, prospective, single center pilot study designed to evaluate the safety of the Temporary Spur Stent System to treat patients with infrapopliteal arterial disease, when used in conjunction with a…
- Trial name
- DEEPER LIMUS (NCT04162418)
- Testing
- Temporary Spur Stent System
- Where
- Austria
- Volunteers
- 26 people
- Sponsor
- ReFlow Medical, Inc.
Peripheral Arterial Disease
Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD)
This study is evaluating whether a therapeutic ultrasound device can improve symptoms in the leg of peripheral arterial disease (PAD) patients 65 years of age and over.
- Trial name
- Waltz (NCT05888740)
- Testing
- VibratoSleeve Therapeutic Ultrasound Device
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Vibrato Medical, Inc.
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.
Diabetes Mellitus, Claudication, Intermittent
Additional Hyperbaric Oxygen After Lower Extremity Amputation
This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or…
- Conditions
- Diabetes Mellitus, Claudication, Intermittent, Critical Limb Ischemia, Osteomyelitis
- Trial name
- AHOLEA (NCT03594344)
- Testing
- Hyperbaric oxygen therapy
- Where
- 2 sites in Norway
- Volunteers
- 120 people
- Sponsor
- Oslo University Hospital
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
Critical Limb Ischemia
Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with critical limb ischemia
- Trial name
- NCT01663376
- Testing
- Autologous Adipose Tissue derived MSCs Transplantation
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- R-Bio
Respiration Failure, Cardio Vascular Disease
COMPARE-VENT Feasibility Pilot Study
Cardiac disease complicated by respiratory insufficiency comprises the most frequent indication for cardiac intensive care unit (CICU) admission, with nearly one-third patients requiring advanced respiratory support and over 20%…
- Conditions
- Respiration Failure, Cardio Vascular Disease, Cardiogenic Pulmonary Oedema, Critical Illness
- Trial name
- NCT07656259
- Testing
- Volume Controlled Mode, Pressure Controlled Mode
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Mayo Clinic
Coronary Artery Disease
Use of Shock Wave Therapy for Neo-Vascularisation in Non-critical Coronary Artery Disease: Validation by Quantitative Cardiac MRI Perfusion
This is a randomised controlled trial aimed to demonstrate the effect of cardiac extracorporeal shock wave therapy (CSWT) on the angiogenesis effect of myocardium by determining myocardial perfusion and left ventricular function…
- Trial name
- CSWT (NCT07068399)
- Testing
- Extracorporeal shock wave therapy
- Where
- Hong Kong
- Volunteers
- 100 people
- Sponsor
- The University of Hong Kong
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
Critical Limb Ischemia
Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities
Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.
- Trial name
- LOA (NCT00767923)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- HyperMed
Peripheral Artery Disease, Peripheral Vascular Disease
Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)
The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00951210
- Testing
- PLX-PAD
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Pluristem Ltd.
Critical Limb Ischemia, Peripheral Arterial Disease - PAD
Autologous Fat Grafting in the Treatment of Critical Limb Ischaemia
Critical Limb Ischaemia (CLI) is a condition characterized by chronic ischemic at-rest pain, ulcers, or gangrene for more than 2 weeks in one or both legs, attributable to objectively proven arterial occlusive disease.CLI is…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease - PAD, Ischemic Ulcer, Ischemic Feet
- Trial name
- NCT04746599
- Testing
- Autologous Fat Grafting
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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
Peripheral Arterial Disease, Critical Limb Ischemia
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)
This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).
- Trial name
- DEEPER REVEAL (NCT05358353)
- Testing
- Bare Temporary Spur Stent System
- Where
- 48 sites in United States
- Volunteers
- 130 people
- Sponsor
- ReFlow Medical, Inc.
Diabetes, Critical Limb Ischemia
Diabetic Foot and Vascular Progenitor Cells
Type of Study: Pilot Study monocenter Study Duration: 18 months Subject Participation Duration: The patients are enrolled for the time of the blood withdrawl. Follow up visit will be after 12 months from the enrollement.
- Trial name
- NCT01269580
- Where
- Italy
- Volunteers
- 122 people
- Sponsor
- IRCCS Multimedica
Peripheral Arterial Occlusive Disease
EXCimEr Laser for Long lENgTh Lesions in Below-The-Knee Arteries Study
This investigation is designed to assess the immediate and long-term angiographic patency outcomes of excimer laser recanalisation followed by PTA in the treatment of long (>50 mm) infrapopliteal lesions in patients with critical…
- Trial name
- EXCELLENT-BTK (NCT00718991)
- Testing
- Spectranetics Turbo elite™ excimer laser catheter
- Where
- 2 sites in Belgium
- Volunteers
- 14 people
- Sponsor
- Flanders Medical Research Program
Peripheral Arterial Disease
Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia
This is a single center, prospective, randomized, unblinded, open-label, active controlled pilot study to evaluate the efficacy and safety of ticagrelor plus aspirin versus clopidogrel plus aspirin in patients with Rutherford…
- Trial name
- NCT02230527
- Testing
- Ticagrelor, Clopidogrel
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- The Cleveland Clinic
Peripheral Vascular Disease, Critical Limb Ischemia
Drug Eluting Stents In The Critically Ischemic Lower Leg
The Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia.
- Trial name
- DESTINY (NCT00510393)
- Testing
- XIENCE V everolimus eluting coronary stent system, MULTILINK VISION coronary stent system
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 140 people
- Sponsor
- Flanders Medical Research Program
Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3)
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
Prospective, multi-center single-arm observational study A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
- Conditions
- Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3), Critical Limb Ischemia (Rutherford Category 4 or 5)
- Trial name
- K-ELUVIA (NCT06234280)
- Testing
- Implantation of Eluvia stent
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yonsei University
Critical Limb Ischemia
Cell Therapy in Critical Limb Ischemia
Study drug and dosage form : Umbilical cord-derived mesenchymal stem cells (HB-MSC1) Dose and route of administration : 60 × 106 cells or 120 x 106 cells to be injected as 30 individual intramuscular injections, once at V0 within…
- Trial name
- CLI (NCT03994666)
- Testing
- allogeneic umbilical cord-derived mesenchymal stem cells
- Where
- France
- Volunteers
- 30 people
- Sponsor
- CHU de Reims