Clinical trials: Critical Limb Ischemia (CLI)
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
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
Critical Limb Ischemia
ACP-01 in Patients With Critical Limb Ischemia
The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of…
- Trial name
- NCT02551679
- Testing
- ACP-01
- Where
- 19 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- Hemostemix
Critical Limb Ischemia
Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores…
- Trial name
- NCT01245335
- Testing
- BMAC injection
- Where
- 34 sites in United States
- Volunteers
- 97 people
- Sponsor
- Harvest Technologies
Critical Limb Ischemia (CLI)
Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System
This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal clinical study in which subjects are evaluated for prevention of major limb amputation in the treatment of non-reconstructable…
- Trial name
- CLIRST III (NCT02538978)
- Testing
- Autologous Bone Marrow Concentrate (aBMC)
- Volunteers
- 224 people
- Sponsor
- Cesca Therapeutics, Inc.
Critical Limb Ischemia, Buerger Disease
Study to Assess the Efficacy and Safety of CLBS12 in Patients with Critical Limb Ischemia (CLI)
A prospective, open label, controlled, randomized, double arm, multi-center study to assess the efficacy and safety of CLBS12 in patients with critical limb ischemia (CLI) due to arteriosclerosis obliterans (ASO) with a single…
- Conditions
- Critical Limb Ischemia, Buerger Disease, Thromboangiitis Obliterans, Atherosclerosis Obliterans
- Trial name
- NCT02501018
- Testing
- CLBS12, SOC
- Where
- 12 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Lisata Therapeutics, Inc.
PAD, Critical Limb Ischemia
Treatment of No-option CLI by G-CSF-mobilized PB-MNC
This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with no-option CLI.
- Conditions
- PAD, Critical Limb Ischemia, Atherosclerotic Ischemic Disease
- Trial name
- NCT03686228
- Testing
- PB-MNC therapy, No-PB-MNC therapy
- Where
- Thailand
- Volunteers
- 40 people
- Sponsor
- Mahidol University
Peripheral Arterial Disease, Critical Limb Ischemia
ACPs in Severe PAD/CLI by Direct Intramuscular Injection
Study title: A Study of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients with Critical Limb Ischemia ( ACPs-CLI ) Principle Investigator: Assoc.Prof. Pramook Mutirangura,M.D.
- Trial name
- NCT00523731
- Testing
- Angiogenic Cell Precursors (ACPs) or Vescell TM
- Where
- Israel
- Volunteers
- 6 people
- Sponsor
- TheraVitae Ltd.
Critical Limb Ischemia, Peripheral Artery Disease
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.
- Trial name
- NCT04304105
- Where
- 25 sites in United States, Puerto Rico
- Volunteers
- 192 people
- Sponsor
- LimFlow, Inc.
Critical Limb Ischemia, Peripheral Artery Disease
Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study
Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from 1.5mm to 4.5mm.
- Trial name
- TOBABTK (NCT02235675)
- Testing
- Tack-It Endovascular System
- Where
- Austria
- Volunteers
- 35 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Diabetic Foot
Induced Wound Healing by Application of Expanded Bone Marrow Stem Cells in Diabetic Patients With Critical Limb Ischemia
Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial.
- Trial name
- NCT01065337
- Testing
- tissue repair cells (TRC), bone marrow stem cells (BMC)
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Ruhr University of Bochum
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
Study to Assess Efficacy and Safety of Bone Marrow Derived Stem Cells in Patients With Critical Limb Ischemia
This study will assess the safety and efficacy of intra-arterial infusion and intramuscular injection of an autologous, bone marrow-derived stem cell preparation (ASCT01) in patients with critical limb ischemia who have exhausted…
- Trial name
- CLI (NCT01867190)
- Testing
- ASCT01 (Autologous Stem Cell Transplantation)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Lifecells, LLC.
Peripheral Artery Disease, Peripheral Vascular Disease
Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia
The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- ACT34-CLI (NCT00616980)
- Testing
- CD34-positive cells, Saline and 5% autologous plasma
- Where
- 12 sites in United States
- Volunteers
- 28 people
- Sponsor
- Losordo, Douglas, M.D.
Critical Limb Ischemia (CLI), Popliteal Nerve Block
Ultrasound-Guided Sciatic Popliteal Nerve Block vs. Erector Spinae Plane Block in Endovascular Management of CLI
Comparison of popliteal sciatic nerve block and erector spinae plane block (ESPB) in patients undergoing endovascular management of critical lower limb ischemia (CLI).
- Conditions
- Critical Limb Ischemia (CLI), Popliteal Nerve Block, ESPB
- Trial name
- NCT06913348
- Testing
- Popliteal sciatic nerve block
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Minia University Hospital
Peripheral Arterial Disease, Peripheral Vascular Diseases
Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access
This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat subjects with critical limb ischemia (CLI) caused by severe PAD.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Critical Limb Ischemia
- Trial name
- MOBILE-CA (NCT02474121)
- Testing
- Bone marrow concentration device
- Where
- 9 sites in United States
- Sponsor
- Zimmer Biomet
Critical Limb Ischemia
Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia
This is a double-blind, placebo controlled study designed to evaluate the safety and efficacy of JVS-100 given to adult subjects with critical limb ischemia (CLI).
- Trial name
- NCT01410331
- Where
- 7 sites in United States, India
- Volunteers
- 48 people
- Sponsor
- Juventas Therapeutics, Inc.
Critical Limb Ischemia Due to Buerger's Disease
A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease
This study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued clinical study in consultation with ICMR, as per recommendation of…
- Trial name
- NCT03056742
- Testing
- Stempeucel(R)
- Where
- 8 sites in India
- Sponsor
- Stempeutics Research Pvt Ltd
Critical Lower Limb Ischemia
Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia
This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels.
- Trial name
- INPACT-DEEP (NCT00941733)
- Testing
- IN.PACT Amphirion, Standard PTA
- Where
- 13 sites in Austria, Belgium and 4 more
- Volunteers
- 358 people
- Sponsor
- Medtronic Endovascular
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