Clinical trials: Critical Ischemia
Critical Limb Ischemia, Infrapopliteal Lesions
Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions.
This study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.
- Trial name
- NCT04365075
- Testing
- Excimer Laser Combined with DCB, Angioplasty Alone
- Where
- China
- Volunteers
- 184 people
- Sponsor
- Xuanwu Hospital, Beijing
Peripheral Vascular Diseases
Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes…
- Trial name
- TAMARIS (NCT00566657)
- Testing
- riferminogene pecaplasmid
- Where
- 32 sites in United States, Argentina and 30 more
- Volunteers
- 525 people
- Sponsor
- Sanofi
Cardiogenic Shock,, With ECMO or IABP Support,
The Analysis of Heart Rate Variability With 24hrs Holter ECG and Serum Cardiac Fibrosis Markers in Critical Illness Patients Who Are With Cardiogenic Shock, With ECMO or IABP Support, or With APACH II Score >25)
The study is to show the prognostic factor of HRV parameter and cardiac fibrosis markers in critical illness patients
- Conditions
- Cardiogenic Shock,, With ECMO or IABP Support,, With APACH II Score >25)
- Trial name
- NCT01993745
- Where
- Taiwan
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Peripheral Arterial Disease, Peripheral Vascular Disease
Peripheral Registry of Endovascular Clinical Outcomes "The PRIME Registry"
The PRIME Registry is a multi-center, observational study designed to evaluate immediate and long-term outcomes (36 months) of endovascular revascularization in patients with critical limb ischemia (CLI) and advanced peripheral…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- PRIME (NCT02786173)
- Where
- 6 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Metro Health, Michigan
Critical Limb Ischemia
Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)
Prospective, randomized, controlled, multi-center study A total of 390 subjects with critical limb ischemia will be included according to inclusion and exclusion criteria.
- Trial name
- NCT02829151
- Testing
- Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) ), Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel, Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol
- Where
- South Korea
- Volunteers
- 390 people
- Sponsor
- Yonsei University
Peripheral Arterial Disease, Critical Limb Ischemia
MOTIV Bioresorbable Scaffold in BTK Artery Disease
The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 36 months) outcome of the MOTIV™ Bioresorbable Scaffold (Reva Medical) in a controlled prospective investigation for the treatment of…
- Trial name
- MOTIV BVS BTK (NCT03987061)
- Testing
- MOTIV BVS
- Where
- 8 sites in Austria, Germany
- Volunteers
- 58 people
- Sponsor
- Dr. Sabrina Overhagen
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
Acceleration Time Assessment for Prediction of Critical Limb Ischemia
Critical Limb Ischaemia (CLI), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it.
- Trial name
- ATACLI (NCT06296576)
- Testing
- arterial ultrasound scan
- Where
- 3 sites in France
- Volunteers
- 431 people
- Sponsor
- Centre Hospitalier le Mans
Peripheral Vascular Diseases
Cell Therapy in Chronic Limb Ischemia
The primary focus of the trial is safety and efficacy of the intra-muscular implantation of either bone-marrow, or peripheral blood mononuclear cells, in critical limb ischemia, as judged by the proportion of patients which are…
- Trial name
- NCT00533104
- Testing
- BM-MNC preparation, PB-MNC preparation
- Where
- France
- Volunteers
- 40 people
- Sponsor
- CHU de Reims
Peripheral Arterial Disease, Angioplasty
Ultrasound to Enhance Paclitaxel Uptake in Critical Limb Ischemia: the PACUS Trial
The PACUS Trial was a single center, single blinded, randomized trial designed to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy to improve local Paclitaxel delivery effects in…
- Trial name
- PACUS (NCT02625740)
- Testing
- Local exposition of target lesion to high intensity, low-frequency ultrasound, drug eluting ballon angioplasty, Flow occlusion with an angioplasty balloon
- Volunteers
- 56 people
- Sponsor
- University of Rome Tor Vergata
Critical Lower Limb Ischemia, Type-2 Diabetes Mellitus
Safety and Efficacy Study of Autologous Bone Marrow Aspirate Concentrate for No-Option Critical Limb Ischemia
The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type…
- Trial name
- DIALEG (NCT01818310)
- Testing
- Group A: Intramuscular, Group B: Intraarterial, Group C: Intravenous
- Where
- Czechia
- Volunteers
- 80 people
- Sponsor
- University Hospital Ostrava
Circulatory Shock, Sepsis
Shock and Acute Conditions OutcOmes Platform
In-hospital mortality of patients admitted in the intensive care unit (ICU) for circulatory shock remains high (between 20 and 40%).
- Conditions
- Circulatory Shock, Sepsis, Cardiogenic Shock, Major Trauma
- Trial name
- ShockCO-OP (NCT06376318)
- Testing
- Inotrope, Mechanical circulatory support, anti-bodies
- Where
- Canada
- Volunteers
- 1,000 people
- Sponsor
- Saint-Louis Hospital, Paris, France
Mechanical Ventilator Weaning, Acute Brain Injury
Brain-injured Patients Extubation Readiness Study
The BIPER study is a stepped wedge cluster randomised clinical trial aiming to decrease extubation failure in critically-ill brain-injured patients with residual impaired consciousness using a simple clinical score.
- Conditions
- Mechanical Ventilator Weaning, Acute Brain Injury, Altered Level of Consciousness, Mechanical Ventilation
- Trial name
- Biper (NCT04080440)
- Testing
- Extubation readiness clinical score, Usual Care
- Where
- 21 sites in France
- Volunteers
- 660 people
- Sponsor
- University Hospital, Clermont-Ferrand
Chronic Critical Ischemia
Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization
Evaluation of a new biological criterion, the local capillary blood lactates to optimize the management of patients with chronic critical ischemia requiring revascularization fast.
- Trial name
- ELIT (NCT01634815)
- Testing
- The Edge
- Where
- 2 sites in France
- Volunteers
- 12 people
- Sponsor
- University Hospital, Strasbourg, France
Critical Limb Ischemia, Peripheral Arterial Disease
ALD-301 for Critical Limb Ischemia, Randomized Trial
This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLI-001 (NCT00392509)
- Testing
- ALDH-br bone marrow cells vs. mononuclear bone marrow cells
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Aldagen
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
Arterial Occlusive Diseases
Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI
The purpose of this study is to determine if concentrated nucleated cells from your own bone marrow, injected or infused into an ischemic limb, will restore sufficient blood flow to avoid amputation.
- Trial name
- NCT00595257
- Testing
- centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Harvest Technologies
Critical Limb Ischemia (CLI)
Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects…
- Trial name
- NCT03006770
- Testing
- PLX-PAD
- Where
- 57 sites in United States, Bulgaria and 7 more
- Volunteers
- 213 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
Multi Organ Failure, Left Ventricular Dysfunction
Acute Cardiac Dysfunction in Critical Illnes
The overall aim of the study is to establish the clinical importance of cardiac dysfunction, by estimating its incidence and impact on short- and long-term outcomes, in a mixed population of critically ill patients with…
- Conditions
- Multi Organ Failure, Left Ventricular Dysfunction, Right Ventricular Dysfunction, Tako Tsubo Cardiomyopathy
- Trial name
- NCT05860504
- Testing
- Echocardiography, Cardiac magnetic resonance imaging, Coronary CT
- Where
- Sweden
- Volunteers
- 592 people
- Sponsor
- Sahlgrenska University Hospital