Clinical trials: Critical Limb-Threatening Ischaemia
Arterial Occlusive Disease, Ulcers
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
The purpose of this study is to evaluate whether intramuscular injections of NL003 into the calf is safe and effective in the treatment of critical limb ischemia
- Conditions
- Arterial Occlusive Disease, Ulcers, Ischemia, Peripheral Vascular Disease
- Trial name
- NL003CLI-II (NCT01548378)
- Testing
- NL003, Normal Saline
- Where
- 9 sites in China
- Volunteers
- 200 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Critical Limb Ischemia
PROMISE International
The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.
- Trial name
- NCT03321552
- Testing
- Percutaneous deep vein arterialization, LimFlow System
- Where
- 12 sites in Austria, Germany and 3 more
- Volunteers
- 34 people
- Sponsor
- LimFlow SA
Critical Limb Ischemia (CLI)
LIFE-BTK PK Sub-study
LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside…
- Trial name
- NCT05208905
- Testing
- Esprit BTK Device
- Where
- 5 sites in United States, Australia and 1 more
- Volunteers
- 9 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia (CLI)
LIFE-BTK Randomized Controlled Trial
The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed…
- Trial name
- LIFE-BTK (NCT04227899)
- Testing
- Esprit BTK Device, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 50 sites in United States, Australia and 4 more
- Volunteers
- 261 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease
A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD
The objective of the clinical trial is to gather evidence on the safety, performance and clinical efficacy Vibrato Sleeve TUS in people with peripheral artery disease (PAD).
- Trial name
- Concerto (NCT05100745)
- Testing
- Therapeutic Device
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Vibrato Medical, Inc.
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.
Peripheral Vascular Disease
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation.
- Trial name
- NCT00300040
- Testing
- Hemoglobin glutamer 250 - bovine, 6% Hydroxyethylstarch
- Where
- 5 sites in South Africa, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Biopure Corporation
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.
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, Critical Limb Ischemia
BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI
The purpose of this study is to determine if an MRI technique called Blood Oxygen Level Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment with standard endovascular therapy in patients…
- Trial name
- NCT02601430
- Testing
- BOLD-MRI
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Zimmer Biomet
Peripheral Arterial Disease
Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia
Near-infrared spectroscopy can be used to determine the relative oxygen saturation in tissues up to 2cm below the skin. It has been investigated, with success, in cerebral, gastrointestinal, and muscle tissue, and shows promise…
- Trial name
- NCT00224328
- Testing
- ODISsey Tissue Oximeter
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- ViOptix Canada
Critical Limb Ischemia
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.
- Trial name
- ILLUMENATE-BTK (NCT03175744)
- Testing
- Stellarex DCB, PTA Catheter
- Where
- 21 sites in United States, Australia and 3 more
- Volunteers
- 82 people
- Sponsor
- Spectranetics Corporation
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
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
Critical Limb Ischemia (CLI)
Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
A Phase III study of PLX-PAD for CLI patients with minor tissue loss who are unsuitable for revascularization has been initiated (PLX-CLI-03, PACE study).
- Trial name
- NCT03886506
- Testing
- PLX-PAD
- Where
- 2 sites in United States
- Sponsor
- Pluristem Ltd.
Critical Limb Ischemia
A Safety and Efficacy Study of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia
This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.
- Trial name
- NCT02477540
- Testing
- Cellgram-CLI
- Sponsor
- Pharmicell Co., Ltd.
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
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.
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive…
- Trial name
- NCT03124875
- Testing
- LimFlow System
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- LimFlow, Inc.
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