Clinical trials: Chronic Limb-threatening Ischemia
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.
Femoropopliteal Disease, Drug Coated Balloon
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
The aim of this clinical trial is to determine whether vessel preparation with a non-compliant scoring balloon before drug-coated balloon (DCB) angioplasty provides superior procedural and clinical outcomes compared with vessel…
- Conditions
- Femoropopliteal Disease, Drug Coated Balloon, Critical Limb-Threatening Ischaemia, Peripheral Arterial Disease
- Trial name
- DASBAD-NC (NCT07764016)
- Testing
- Non-compliant Plain Balloon angioplasty (PBA), Non-compliant Scoring Balloon Angioplasty (SB)
- Volunteers
- 142 people
- Sponsor
- Marc Sirvent
Chronic Limb-Threatening Ischemia
IVUS Guidance in BTK Interventions
Chronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease in which very poor blood flow in the arteries below the knee can cause rest pain, non-healing wounds, and even loss of the limb.
- Trial name
- IMAGE-BTK (NCT07731997)
- Testing
- Intravascular ultrasound-guided EVT, Angiography-guided EVT
- Where
- 4 sites in Taiwan
- Volunteers
- 212 people
- Sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
Peripheral Arterial Disease
SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs
A research project capturing experiences of patients with critical limb threatening ischemia, with the ultimate goal of setting new standards for diagnosing, describing detailed patient-centered outcomes, and evaluating the…
- Trial name
- SCOPE-CLI (NCT04710563)
- Where
- United States
- Volunteers
- 458 people
- Sponsor
- Yale University
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase…
- Conditions
- Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans
- Trial name
- NCT07023965
- Testing
- NL003
- Where
- 5 sites in China
- Volunteers
- 542 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Lower Limb Ischemia, Peripheral Vascular Diseases
An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)
Endovascular treatment of below the knee disease is a well-established therapy to improve outcomes in patients with critical limb ischemia.
- Trial name
- RANGER-BTK (NCT02856230)
- Testing
- Ranger SL DEB
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Peripheral Artery Disease Without Critical Limb Ischemia
Non-Healing Ulcers Without Critical Limb Ischemia
Background: Lower limb arterial revascularization procedures, either percutaneously or surgically performed, are an established treatment modality of ischemic foot ulcers, especially in the setting of a critical limb ischemia.
- Trial name
- NEWLI (NCT01666093)
- Testing
- Angioplasty of the lower limbs vessels
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- University Hospital, Geneva
Peripheral Arterial Disease
A ProspeCtive mUlticenteR Investigation on RENzar Stent Safety and Efficacy in the Treatment of Patients With Femoro-popliteal Disease in Tuscany (CURRENT Registry)
CURRENT Registry is a physician-initiated prospective, multicenter, post-market, single-arm study with a plan to include approximately 100 patients eligible to be treated with RenzanTM Peripheral Stent System.
- Trial name
- CURRENT (NCT05701293)
- Testing
- Endovascular implantation of Renzan Stent
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Azienda Ospedaliera Universitaria Senese
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
Peripheral Vascular Disease
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD).
- Trial name
- NCT00059644
- Testing
- Ecraprost in lipid emulsion
- Where
- 27 sites in United States, United Kingdom
- Volunteers
- 560 people
- Sponsor
- Tanabe Pharma Corporation
Critical Limb Ischemia
Study of the Clinical Efficacy of Autologous SCT in Patients With Critical Limb Ischemia
Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia
- Trial name
- NCT01311011
- Testing
- SCT
- Where
- Saudi Arabia
- Volunteers
- 26 people
- Sponsor
- King Faisal Specialist Hospital & Research Center
Critical Limb Ischemia
Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.
Clinical trial phase I / II, prospective, multicenter, open, randomized, parallel-groups controlled by two levels of dose to assess the safety and feasibility of the infusion of mesenchymal stem cells from adipose tissue…
- Trial name
- NCT01745744
- Testing
- Mesenchymal stem cells from adipose tissue
- Where
- 2 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
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
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
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
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
SELUTION4BTK Trial
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in…
- Trial name
- NCT05055297
- Testing
- SELUTION SLR™ DEB 014, Plain (Uncoated) Balloon Angioplasty (PTA)
- Where
- 48 sites in United States, Austria and 8 more
- Volunteers
- 376 people
- Sponsor
- M.A. Med Alliance S.A.
Chronic Limb Threatening Ischemia
Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI)
Chronic limb-threatening ischemia (CLTI) is a serious condition that happens when blood flow to the legs or feet is severely reduced.
- Trial name
- NCT07175129
- Testing
- Transverse Tibial Bone Transport, TrueLok Elevate
- Where
- United States
- Sponsor
- University Hospitals Cleveland Medical Center
Critical Limb Ischemia, Peripheral Artery Disease
Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
The aim of this observational study is to evaluate the outcomes and safety of the Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease (PAD) in below-the-knee vessels
- Trial name
- Apollo (NCT02539940)
- Testing
- Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV
- Where
- 10 sites in Germany
- Volunteers
- 166 people
- Sponsor
- Jena University Hospital
Vascular Diseases, Peripheral Artery Disease
RECCORD (Recording Courses of Vascular Diseases) Registry
The RECording COurses of vasculaR Diseases registry (RECCORD registry) is an observational, prospective, multicentre, all-comers registry platform.
- Conditions
- Vascular Diseases, Peripheral Artery Disease, Claudication, Critical Limb Ischemia
- Trial name
- RECCORD (NCT03448029)
- Where
- Germany
- Volunteers
- 6,000 people
- Sponsor
- Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
Stable Coronary Artery Disease, Acute Coronary Syndromes
Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease
Numerous clinical studies have highlighted the role of macrophages in the destabilization of coronary lesions; however, there is limited literature on the relationship between circulating monocytes and intraplaque macrophages.
- Conditions
- Stable Coronary Artery Disease, Acute Coronary Syndromes, Critical Limb Ischemia, Intermittent Claudication
- Trial name
- NCT07588295
- Testing
- Optical Coherence Tomography assessment
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Maria Cecilia Hospital