Clinical trials: Critical Ischemia
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 Arterial Disease, Critical Limb Ischemia (CLI)
Pressure (Fractional Flow Reserve) and Flow (Vascular Flow Reserve) Measurements During Peripheral Arterial Interventions
Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) have been originally developed for physiological assessment of coronary artery disease and may hold potential in the management of Peripheral Arterial Disease (PAD) as…
- Trial name
- FLOW-PAD (NCT07052435)
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- Dr. Konstantinos Katsanos
Peripheral Vascular Diseases, Critical Limb Ischemia
Diamondback in Peripheral Vascular Disease
This is a prospective, nonrandomized, single-arm study using CSI Orbital Atherectomy System in patients with PAD (total occlusions or significant stenosis).
- Trial name
- DIAMOND-PAD (NCT03455374)
- Testing
- Treatment with CSI atherectomy device
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Arkansas Heart Hospital
Ischemic Stroke, Ischaemic Stroke With Coma
Decision Aid Feasibility Trial for Families of Critically Ill Stroke Patients
Severe strokes, including large artery acute ischemic stroke and intracerebral hemorrhage, continue to be the leading cause of death and disability in adults in the U.S.
- Conditions
- Ischemic Stroke, Ischaemic Stroke With Coma, Intracerebral Hemorrhage, Hemorrhagic Stroke
- Trial name
- NCT04143113
- Testing
- Decision Aid
- Where
- 2 sites in United States
- Sponsor
- University of Massachusetts, Worcester
Critical Limb Ischemia
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia.
- Trial name
- NCT01064440
- Testing
- Low Dose VM202, High Dose VM202
- Where
- 16 sites in United States, South Korea
- Volunteers
- 52 people
- Sponsor
- Helixmith Co., Ltd.
Critical Limb Ischemia (CLI)
Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Non-diabetic Patients With Critical Limb Ischemia (CLI).
Phase II Clinical Trial, a prospective, multicenter, open, randomized, parallel-group controlled with three levels of dose. The hypothesis of the test we propose is that the mononuclear cells of bone marrow provide progenitor…
- Trial name
- NCT01408381
- Testing
- Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells
- Where
- 5 sites in Spain
- Volunteers
- 38 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Peripheral Artery Disease (PAD), Femoropopliteal Artery Disease
Chocolate Balloon vs Standard Balloon Angioplasty Before Drug-Coated Balloon Treatment for Femoropopliteal Artery Narrowing or Blockage
The goal of this clinical trial is to learn if using the Chocolate Percutaneous Transluminal Angioplasty (PTA) balloon for vessel preparation improves outcomes before drug-coated balloon (DCB) treatment in patients with…
- Conditions
- Peripheral Artery Disease (PAD), Femoropopliteal Artery Disease, Vascular Lesion Preparation, Critical Limb-Threatening Ischemia
- Trial name
- CHOICE (NCT07471087)
- Testing
- Chocolate PTA Balloon, Standard Balloon Angioplasty (POBA)
- Volunteers
- 242 people
- Sponsor
- Felice Pecoraro
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
Prospective Observation Study of Outcome of Interventions for Critical Ischemia
Severe atherosclerosis in the leg arteries is termed critical limb ischemia (CLI). This condition gives great suffering for the patients in terms of pain, wounds and often developing gangrene.
- Trial name
- PROVENCE (NCT01794494)
- Testing
- Bypass surgery, Endovascular recanalization
- Where
- Sweden
- Volunteers
- 190 people
- Sponsor
- Sahlgrenska University Hospital
Critical Limb Ischemia
Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia
Background: Up to 10% of patients with peripheral arterial disease (PAD) will develop critical limb ischemia (CLI) which is a decrease of blood flow in the arteries of the limb.
- Trial name
- RIVAL-PAD (NCT02260622)
- Testing
- rivaroxaban plus aspirin, clopidogrel plus aspirin
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Ottawa Hospital Research Institute
Peripheral Arterial Disease
Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone in Europe
The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages.
- Trial name
- AMBITION BTK (NCT07472439)
- Testing
- Auryon Atherectomy System, Balloon Angioplasty
- Volunteers
- 50 people
- Sponsor
- Angiodynamics, Inc.
Peripheral Arterial Disease, Claudication
Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
The Phoenix Post-Approval Registry is a prospective, multi-center, single arm registry sponsored by Volcano Corporation to evaluate the short and long term performance and clinical outcomes of the Phoenix Atherectomy System.
- Conditions
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT02475200
- Testing
- Atherectomy
- Where
- 5 sites in United States
- Volunteers
- 500 people
- Sponsor
- Volcano Corporation
Critical Limb Ischemia, Peripheral Arterial Disease
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- MOBILE (NCT01049919)
- Testing
- Bone marrow concentration device
- Where
- 25 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Critical Limb Ischemia
Tolerance Study of Allogeneic of Adipose Tissue Derived Mesenchymal Stroma/Stem Cells (AdMSC) Transplantation in Patients With Critical Limb Ischemia.
Critical limb ischemia (CLI) is the most severe stage of peripheral arterial disease (PAD). Cell therapy delivered to the ischemic muscle constitutes a promising approach to treat CLI patients with no or poor options of…
- Trial name
- AlloDREAM (NCT06795620)
- Testing
- Adipose tissue derived mesenchymal Stroma/stem Cells transplantation
- Where
- France
- Volunteers
- 10 people
- Sponsor
- University Hospital, Toulouse
Critical Limb Ischemia
Cost Analysis of Vascular Surgical Techniques
Whilst mortality rates and surgical limitations are widely known and understood for each intervention performed, the cost implications, in UHL, are not known.
- Trial name
- NCT06367803
- Where
- Ireland
- Volunteers
- 200 people
- Sponsor
- University Hospital of Limerick
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
Critical Limb Ischemia
A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia
Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study
- Trial name
- NCT02974179
- Testing
- Subjects from Study AG-CLI-0206 who received AMG0001
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- AnGes USA, Inc.
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
Cardiogenic Shock
Cardiogenic Shock Working Group Registry
The Cardiogenic Shock Working Group is a multicenter registry where we collect de-identified clinical variables from the medical records and follow-up phone calls of shock patients from multiple institutions and centralize this…
- Trial name
- CSWG (NCT04682483)
- Testing
- Vasopressor, Inotrope, Acute Mechanical Circulatory Support Devices
- Where
- 16 sites in United States
- Volunteers
- 20,000 people
- Sponsor
- Tufts Medical Center
Mechanical Ventilation Complication, Arterial Thrombosis
Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment
Investigators will conduct a pragmatic randomized trial to investigate the non-inferiority of restricted use of invasive arterial lines compared to standard arterial line use.
- Conditions
- Mechanical Ventilation Complication, Arterial Thrombosis, Limb Ischemia, Shock
- Trial name
- GRACE (NCT05411315)
- Testing
- Restricted-use of arterial catheter, Standard-use of arterial catheter
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Dartmouth-Hitchcock Medical Center