Clinical trials: Critical Ischemia Limb
Lower Limb Ischaemia
Development and Validation of a Clinical Prediction Rule for Lower Limb Critical Limb Ischaemia (PREDICCMI)
Critical limb ischaemia (CLI) is the most serious stage of peripheral occlusive arterial disease (POAD). Despite progress in the revascularization procedures, half these patients experience amputation or death after one year.
- Trial name
- PREDICCMI (NCT02637492)
- Testing
- Collection of clinical signs and symptoms
- Where
- 3 sites in France
- Volunteers
- 603 people
- Sponsor
- University Hospital, Bordeaux
Ischemia
Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries…
- Trial name
- NCT02758847
- Testing
- Angiogram, Medtronic DCB (paclitaxel)/stent, Angiogram, Bard DCB (paclitaxel)/stent
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Rabih A. Chaer
Critical Limb Ischemia
miRNAs in Critical Limb Ischemia (miRNACLI)
For the present study, 40 patients affected by critical limb ischemia of different severity will be enrolled: patients affected by critical limb ischemia undergoing subgenual femoropopliteal bypass; patients suffering from…
- Trial name
- miRNACLI (NCT06066268)
- Testing
- Critical limb ischemia: analysis of RNAs, Controls: analysis of RNAs
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- IRCCS Policlinico S. Donato
Critical Limb Ischemia
New Oxymetry Indices in Critical Limb Ischemia
Transcutaneous oxygen tension (TcpO2) at rest, sensitized by oxygen inhalation tests, is widely applied for the evaluation of chronic critical limb ischemia (CLI).
- Trial name
- NOVICE (NCT04209998)
- Testing
- transcutaneous oximetry
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Angers
Critical Limb Ischemia
Alprostadil as an Adjuvant Therapy With Indirect Angiosomal Revascularization in Critical Limb Ischemia.
The aim of this study is to assess the efficacy of Alprostadil (Prostaglandin E2) as adjuvant therapy after failure of direct but indirect angiosomal revascularization in patients with critical limb ischemia.
- Trial name
- NCT04312555
- Testing
- Alprostadil
- Volunteers
- 30 people
- Sponsor
- Assiut University
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
ILLUMENATE Below-The-Knee (BTK) Arteries: a Post Market Clinical Study
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the StellarexTM 0.014" OTW Drug-coated Angioplasty Balloon in the treatment of lesions in "below the…
- Trial name
- BTK PMS (NCT03395236)
- Testing
- StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon
- Where
- 10 sites in Germany, Netherlands and 1 more
- Volunteers
- 49 people
- Sponsor
- Spectranetics Corporation
Chronic Limb Threatening Ischemia
Outcomes of Atherectomy and Balloon Angioplasty Compared to Conventional Angioplasty in Infra-popliteal Chronic Limb-Threatening Ischemia
Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral artery disease (PAD), characterized by rest pain, non-healing ulcers, or gangrene, and is associated with high morbidity and risk of…
- Trial name
- NCT07120555
- Testing
- atherectomy, Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Assiut University
Peripheral Vascular Disease, Diabetic Foot
Autologous Bone Marrow Stem Cell Transplantation for Critical, Limb-threatening Ischemia
Critical limb ischemia is a condition where the blood circulation in the limbs, in most cases the legs, is decreased so that pain and non healing wounds ensue. Mostly, this is a sequel of arteriosclerosis and/or diabetes.
- Conditions
- Peripheral Vascular Disease, Diabetic Foot, Peripheral Arterial Occlusive Disease, Leg Ulcer
- Trial name
- BONMOT (NCT00434616)
- Testing
- Autologous bone marrow cell concentrate transplantation, saline injection
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- Franziskus-Krankenhaus
Buerger Disease, Arteriosclerosis Obliterans
TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation
Clinical studies have established that implantation of bone marrow mononuclear cells (BM-MNCs) or peripheral blood mononuclear cells (PB-MNCs) into ischaemic limbs increases collateral vessel formation.
- Trial name
- NCT00145262
- Testing
- Autologous Bone Marrow Mononuclear Cell Implantation
- Where
- Japan
- Sponsor
- Nagoya University
Peripheral Arterial Disease
Iloprost Therapy in Patients With Critical Limb Ischemia
Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.
- Trial name
- NCT01458041
- Testing
- Iloprost (Ilomedin, BAYQ6256)
- Where
- Hungary
- Volunteers
- 126 people
- Sponsor
- Bayer
Peripheral Arterial Disease, Common Femoral Artery Stenosis
Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy
Prospective, nonrandomized, multicenter, national, multidisciplinary, real-world data collection with the aim to evaluate the short-term safety and efficacy of intravascular lithotripsy in the treatment of steno-obstructive…
- Conditions
- Peripheral Arterial Disease, Common Femoral Artery Stenosis, Common Femoral Artery Occlusion, Critical Limb-Threatening Ischemia
- Trial name
- FESTIVAL (NCT05821829)
- Testing
- Intravascular litothripsy (IVL)
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- University of Pisa
Critical Limb Ischemia (CLI)
Comprehensive Limb Evaluation and Arterial Revascularization With Toe Pressure Optimization Registry
To address the heterogeneity of practices, better understand the outcomes of cricital limb theatening ischemia (CLTI) patients after endovascular interventions, and recognize effective endovascular options for infrapopliteal…
- Trial name
- CLEAR TOE (NCT07014072)
- Testing
- intensive toe pressure evaluation, data collection
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Bordeaux
Peripheral Vascular Diseases, Peripheral Arterial Disease
Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstruction of MSOT Images
The aim of this explorative pilot study is to present muscle perfusion of the lower extremity in patients with PAD using the Multispectral Optoacoustic Tomography (MSOT) method to build a 3D reconstruction of the calf muscle.
- Trial name
- NCT05110677
- Testing
- Multispectral Optoacoustic Tomography (MSOT)
- Where
- Germany
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- University Hospital Erlangen
Critical Limb Ischemia, Peripheral Arterial Disease
Chelation Therapy in Diabetic Patients With Critical Limb Ischemia
This is a Pilot Trial Using Chelation Therapy for Limb Preservation in Diabetic Patients with Critical Limb Ischemia.
- Trial name
- TACT-PAD (NCT03424746)
- Testing
- disodium EDTA
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Mt. Sinai Medical Center, Miami
Chronic Limb-Threatening Ischemia
Pivotal Trial of the Boomerang Catheter for pDVA
The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia.
- Trial name
- NCT06311773
- Testing
- Boomerang Catheter
- Where
- 25 sites in United States
- Volunteers
- 120 people
- Sponsor
- Aveera Medical, Inc.
Chronic Limb-threatening Ischemia, Diabetes Mellitus
Bone Marrow Mononuclear Cells vs Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb Ischemia
Patients in the severe stages of Chronic limb-threatening ischemia (CLTI) are prone to amputation and death, leading to poor quality of life and a great socioeconomic burden.
- Trial name
- NCT05631444
- Testing
- Cell-based therapy
- Where
- Colombia
- Volunteers
- 24 people
- Sponsor
- Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Critical Limb Ischemia (CLI), Peripheral Vascular Disease (PVD)
Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI)
The purpose of this study is to evaluate the safety of administration of marrow-derived autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for the treatment of Critical Limb Ischemia (CLI).
- Trial name
- CLI (NCT01386216)
- Testing
- Magellan®
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Arteriocyte, Inc.
Peripheral Artery Disease
Safety/Feasibility of Vonapanitase Following Angioplasty for Patients With Peripheral Artery Disease (PAD) Below the Knee (BTK)
The research study is designed to assess the technical feasibility and safety of a perivascular injection of vonapanitase delivered via micro-infusion catheter to the distal popliteal, tibial or peroneal arteries immediately…
- Trial name
- NCT02956993
- Testing
- vonapanitase
- Where
- 9 sites in United States
- Volunteers
- 29 people
- Sponsor
- Proteon Therapeutics
Critical Limb Ischemia, Atherosclerosis
Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia.
- Conditions
- Critical Limb Ischemia, Atherosclerosis, Ischemic Ulcer, Gangrene
- Trial name
- NCT01833585
- Testing
- Peripheral blood mononuclear cell
- Where
- Thailand
- Volunteers
- 8 people
- Sponsor
- Mahidol University