Clinical trials: Chronic Limb-threatening Ischemia
Chronic Limb-Threatening Ischemia, Surgery-Complications
Use of CPETarm for Risk Stratification of Patients With CLTI
This is a prospective cohort study of patients undergoing surgery for chronic limb threatening ischaemia. Prior to surgery, patients will undergo CardioPulmonary Exercise testing (CPET) using an arm ergometer.
- Trial name
- NCT06404229
- Testing
- CardioPulmonary Exercise Testing
- Where
- United Kingdom
- Volunteers
- 120 people
- Sponsor
- University of Manchester
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
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
Critical Limb Ischemia
Drug Impregnated Bioabsorbable Stent in Asian Population Extremity Arterial Revascularization (DISAPEAR Study)
The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular) in subjects with critical limb ischemia (CLI) following…
- Trial name
- DISAPEAR (NCT02043795)
- Testing
- BVS, Abbott Vascular
- Where
- Singapore
- Volunteers
- 15 people
- Sponsor
- Changi General Hospital
Chronic Limb-Threatening Ischemia
AcoArt Litos PCB Below-the-knee Global Trial
The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of…
- Trial name
- NCT06330493
- Testing
- PCB, PTA
- Where
- 18 sites in United States, Austria and 1 more
- Volunteers
- 75 people
- Sponsor
- Acotec Scientific Co., Ltd
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 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 Limb Ischemia
Acceleration Time Assessment for Prediction of Critical Limb Ischemia
Critical Limb Ischaemia (CLI), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it.
- Trial name
- ATACLI (NCT06296576)
- Testing
- arterial ultrasound scan
- Where
- 3 sites in France
- Volunteers
- 431 people
- Sponsor
- Centre Hospitalier le Mans
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
Structured Educational Program vs Standard Care in Pre-surgical Critical Limb Ischemia Patients
Critical limb ischemia (CLI) is a severe condition where poor blood flow to the legs causes pain, non-healing wounds, and may require amputation. It affects 10% of people over 40, rising to 20% in those over 70.
- Conditions
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Health Education
- Trial name
- NCT07201168
- Testing
- Structured Multimodal Educational Program for Critical Limb Ischemia, Standard medical care
- Where
- Kazakhstan
- Volunteers
- 184 people
- Sponsor
- Tulip Medicine
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, Extracellular Matrix Alteration
Matrix Metalloproteinases in Patients With Critical Limb Ischemia Undergoing Surgical Revascularization
In the present study the investigators will evaluate MMPs. serum levels variations in patients affected by critical limb ischemia, before and after lower limb surgical revascularization through venous or prosthetic bypass.
- Conditions
- Critical Limb Ischemia, Extracellular Matrix Alteration, Peripheral Revascularisation
- Trial name
- ROMAMETA (NCT02388867)
- Testing
- Polytetrafluoroethylene (PTFE) bypass grafting., Autogenous vein bypass grafting
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Catanzaro
CLTI Defined as Rutherford Category 4 or 5
Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization
Chronic limb threatening ischemia (CLTI) is defined as ischemic foot pain at rest or non-healing foot wounds that is attributable to severe peripheral arterial disease (PAD).Revascularization is the cornerstone of therapy to…
- Trial name
- DAPTCLTI (NCT07512960)
- Testing
- Clopidogrel 75 mg/day
- Where
- France
- Volunteers
- 614 people
- Sponsor
- Fondation Hôpital Saint-Joseph
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
Lower Limb Ischemia
Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions
The purpose of this study is to evaluate the technical feasibility, safety, and 1-year clinical efficacy of the endovascular treatment of patients with atherosclerotic common femoral artery (CFA) obstructions with associated…
- Trial name
- NCT05569369
- Testing
- angioplasty and stenting
- Volunteers
- 25 people
- Sponsor
- Sohag University
Critical Limb Ischemia
Mesenchymal Stem Cells in Critical Limb Ischemia
This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.
- Trial name
- NCT00883870
- Testing
- mesenchymal stem cells, Plasmalyte A
- Where
- 4 sites in India
- Volunteers
- 20 people
- Sponsor
- Stempeutics Research Pvt Ltd
Peripheral Arterial Disease, Cardiovascular Diseases
Allogeneic Mesenchymal Stromal Cells for Angiogenesis and Neovascularization in No-option Ischemic Limbs
The primary objective of this trial is to investigate whether intramuscular administration of allogeneic mesenchymal stromal cells (MSC) is safe and potentially effective, assessed as a composite outcome of mortality, limb…
- Conditions
- Peripheral Arterial Disease, Cardiovascular Diseases, Vascular Diseases
- Trial name
- SAIL (NCT03042572)
- Testing
- Allogeneic Mesenchymal Stromal Cell
- Where
- Netherlands
- Volunteers
- 60 people
- Sponsor
- Martin Teraa, MD, PhD
Major Adverse Limb Events, Major Adverse Cardiovascular Events
Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage
Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades.
- Conditions
- Major Adverse Limb Events, Major Adverse Cardiovascular Events, Peripheral Artery Disease, Critical Limb Ischemia
- Trial name
- TAMIS (NCT06318767)
- Testing
- hemodynamic measure of the Systolic Time Rise
- Where
- France
- Volunteers
- 134 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Critical Limb Ischemia
MOTIV BTK Randomized Controlled Trial
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
- Trial name
- NCT05406622
- Testing
- MOTIV Sirolimus-Eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 26 sites in United States, Germany
- Volunteers
- 292 people
- Sponsor
- REVA Medical, Inc.
Peripheral Arterial Disease, Critical Limb Ischemia
Serranator Recoil Study
The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as…
- Trial name
- NCT05161039
- Testing
- Serranator, POBA
- Where
- 2 sites in United States, Germany
- Volunteers
- 20 people
- Sponsor
- Cagent Vascular LLC
Ischemia
Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI)
Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in vasculogenesis
- Trial name
- NCT00498069
- Testing
- Harvest Smartprep2 BMAC System, SmartPReP2 BMAC System
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Harvest Technologies