Clinical trials: Chronic Limb Ischemia
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 Artery Disease
Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth for the Treatment of Critical Limb Ischemia
MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia
- Trial name
- NCT01351610
- Testing
- PTA + Infusion of MSC_Apceth, PTA
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Apceth GmbH & Co. KG
Critical Limb Ischemia, Peripheral Arterial Disease
IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA
To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the…
- Trial name
- NCT02963649
- Testing
- DCB, PTA
- Where
- 9 sites in Belgium, France and 3 more
- Volunteers
- 50 people
- Sponsor
- Medtronic Endovascular
Critical Limb Ischemia
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI).
- Trial name
- REVIVE (NCT01483898)
- Testing
- Ixmyelocel-T
- Where
- 86 sites in United States
- Volunteers
- 41 people
- Sponsor
- Vericel Corporation
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.
Peripheral Arterial Disease, Chronic Limb Ischemia
Improving Radiological Outcomes in Arterial Disease - A Pilot Evaluation of the Pedra Tissue Perfusion Monitoring System
The Pedra Technologies' PedraTM device is a non-invasive, diagnostic device intended to measure foot perfusion by assessing blood flow.
- Trial name
- IROAD (NCT03294902)
- Testing
- Pedra Tissue Perfusion Monitor
- Where
- United Kingdom
- Volunteers
- 68 people
- Sponsor
- Pedra Technology, PTE LTD
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.
Peripheral Arterial Disease
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the…
- Trial name
- Axys ACHIEVE (NCT04282161)
- Testing
- Axys EX device
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03174522
- Testing
- REX-001
- Where
- 15 sites in Czechia, Hungary and 4 more
- Volunteers
- 49 people
- Sponsor
- Ixaka Ltd
Critical Limb Ischemia (CLI)
Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)
This is an Expanded Access program (EAP), sponsored by WideTrial for the treatment of critical limb ischemia (CLI). Widetrial, an Expanded Access specialist, has arranged to supply participating sites with PLX-PAD for CLI…
- Trial name
- NCT03746899
- Testing
- PLX-PAD
- Sponsor
- WideTrial, Inc.
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.
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, Buerger's Disease
A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesenchymal Stem Cells in Patients With Critical Limb Ischemia Due to Buergers Disease
This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy of different doses of Stempeucel in critical limb ischemia patients.
- Trial name
- NCT01484574
- Testing
- Allogeneic Mesenchymal Stem Cells
- Where
- 10 sites in India
- Volunteers
- 90 people
- Sponsor
- Stempeutics Research Pvt Ltd
Peripheral Arterial Disease
HORIZON Prospective Clinical Investigation
The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX \& PULL in a prospective investigation for the treatment of…
- Trial name
- NCT05234164
- Testing
- EXIST 6F NiTi Stent System FLEX, EXIST 6F NiTi Stent System PULL
- Where
- 2 sites in Italy, Poland
- Volunteers
- 69 people
- Sponsor
- Qmedics AG
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
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.
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)
Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic stem/progenitor cells (HSPC) (BGC101), in the…
- Conditions
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- EnEPC-CLI (NCT02805023)
- Testing
- BGC101 (autologous EnEPC preparation), Control medium
- Where
- 5 sites in United States, Israel
- Volunteers
- 40 people
- Sponsor
- BioGenCell Ltd.
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.
Critical Limb Ischemia
Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT
Using gene therapy to express active telomerase (hTERT) in human cells has the potential to treat many diseases related to aging, including critical limb ischemia (CLI).
- Trial name
- NCT04110964
- Testing
- AAV-hTERT
- Where
- Colombia
- Volunteers
- 5 people
- Sponsor
- Libella Gene Therapeutics
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.