Clinical trials: Chronic Limb-threatening Ischemia
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
- Conditions
- Critical Limb Ischemia, Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
- Trial name
- NCT05313165
- Testing
- LimFlow Stent Graft System
- Where
- 30 sites in United States
- Volunteers
- 100 people
- Sponsor
- LimFlow, Inc.
Peripheral Artery Disease, Quality of Life
VADOplex Critical Limb Ischemia Study
In patients with critical limb ischemia (CLI) and foot ulcers wound healing is an important goal which can normally only be achieved after sufficient treatment of the underlying ischemia (revascularization either by an operation…
- Conditions
- Peripheral Artery Disease, Quality of Life, Wound Healing
- Trial name
- NCT02034539
- Testing
- VADOplex system
- Where
- Germany
- Volunteers
- 38 people
- Sponsor
- Asklepios Kliniken Hamburg GmbH
Chronic Limb-Threatening Ischemia, Colorectal Carcinoma
Comparison of Outcomes of Patients With Stage IV Chronic Limb-threatening Ischemia and Colorectal Cancer
Colorectal cancer (CRC) and chronic limb-threatening ischemia (CLTI) are relatively frequent and potentially fatal diseases. However, studies that are comparing clinical outcomes between CRC and CLTI patients in more advanced…
- Conditions
- Chronic Limb-Threatening Ischemia, Colorectal Carcinoma, Colorectal Carcinoma Metastatic in the Liver
- Trial name
- NCT05116696
- Testing
- For chronic limb-threatening ischemia (CLTI) patients revascularisation surgery; for colorectal liver metastasis (CRLM) patients metastatic liver surgery
- Where
- Serbia
- Volunteers
- 836 people
- Sponsor
- Clinical Centre of Serbia
Vascular Diseases, Diabetes
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I)
The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts.
- Trial name
- DCLI-I (NCT01171703)
- Testing
- femoral-popliteal bypass, stent
- Where
- 3 sites in China
- Volunteers
- 70 people
- Sponsor
- Peking Union Medical College Hospital
Chronic Total Occlusion of Artery of the Extremities
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond…
- Trial name
- NCT06492733
- Testing
- FastWire System - Peripheral
- Where
- 6 sites in United States
- Volunteers
- 65 people
- Sponsor
- Versono Medical Ltd
Arterial Occlusive Disease, Ischemia
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-2)
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, Ischemia, Ulcers, Peripheral Vascular Disease
- Trial name
- NCT04274049
- Testing
- NL003, Normal Saline
- Where
- 21 sites in China
- Volunteers
- 242 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
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
Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia
The purpose of this study is to compare the effects (positive and negative) of two different devices available to treat people with critical limb ischemia, which involves a sudden decrease in blood flow to the leg that causes a…
- Trial name
- NCT00869375
- Testing
- Endovascular peripheral intervention
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Oklahoma
Peripheral Arterial Disease, Critical Limb-Threatening Ischaemia
Shockwave ®S4 Catheter IVL to Treat Infrapopliteal Calcified Stenoses and/or Occlusions in CLTI Patients (LEGACY)
The study will evaluate the safety and efficacy of Peripheral Intravascular Lithotripsy system with Shockwave S4 catheter® for the treatment of de novo, re-stenosis or re-occlusive,calcified chronic total occlusion (CTOs) lesions…
- Trial name
- LEGACY (NCT05755412)
- Where
- 6 sites in Italy
- Volunteers
- 9 people
- Sponsor
- EndoCore Lab s.r.l.
Chronic Limb Threatening Ischemia
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Peripheral arterial disease (PAD) is a widespread pathology affecting over 200 million adults globally and is primarily caused by atherosclerosis.
- Trial name
- LASER-S (NCT07858539)
- Testing
- Laser atherectomy followed by Sirolimus-eluting balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions
- Where
- Greece
- Volunteers
- 55 people
- Sponsor
- Attikon Hospital
Chronic Limb-Threatening Ischemia
The Role of Glass Stage Compared to WIFI Stage in Predicting Limb Salvage
compare between GLASS and WIFI Staging in predicting limb salvage in patients with chronic limb threatening ischemia ( CLTI) undergoing endovascular revascularization.
- Trial name
- NCT06209866
- Testing
- PTA
- Volunteers
- 28 people
- Sponsor
- Assiut University
Peripheral Artery Disease, Peripheral Vascular Disease
Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia
The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- ACT34-CLI (NCT00616980)
- Testing
- CD34-positive cells, Saline and 5% autologous plasma
- Where
- 12 sites in United States
- Volunteers
- 28 people
- Sponsor
- Losordo, Douglas, M.D.
Critical Limb Ischemia, Infrapopliteal Arterial Occlusive Disease
Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries(SENS-BTK)
The objectives of this study are to compare directly conventional balloon angioplasty alone versus. balloon angioplasty with routine stenting - that is, to determine whether angioplasty with self-expanding stent is superior to…
- Trial name
- SENS-BTK (NCT01644487)
- Testing
- self-expanding nitinol stent, balloon angioplasty
- Where
- South Korea
- Volunteers
- 122 people
- Sponsor
- Korea University Guro Hospital
Peripheral Vascular Disease, Intermittent Claudication
Efficacy Study of Iliac Stents to Treat TASC A-B-C-D Iliac Artery Lesions
The BRAVISSIMO trial wants to investigate in a controlled setting, the long-term (up to 24 months) outcome of the self-expanding nitinol Absolute Pro (Abbott Vascular) and the balloon-expandable Omnilink Elite (Abbott Vascular)…
- Conditions
- Peripheral Vascular Disease, Intermittent Claudication, Critical Limb Ischemia
- Trial name
- BRAVISSIMO (NCT00764777)
- Testing
- iliac stenting
- Where
- 5 sites in Belgium
- Volunteers
- 325 people
- Sponsor
- Flanders Medical Research Program
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
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
Peripheral Vascular Diseases, Peripheral Arterial Disease
Calf Muscle Perfusion in Patients With Intermittent Claudication by Non-invasive MSOT
The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the calf muscle based on multispectral optoacoustic tomography (MSOT) in a cross-sectional…
- Conditions
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Intermittent Claudication
- Trial name
- MSOT_IC (NCT05373927)
- Testing
- Multispectral Optoacoustic Tomography (MSOT)
- Where
- Germany
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ulrich Rother
Limb Ischemia, Diabetic Foot
Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia
Phase II national, multicenter, double-blind, randomized, placebo-controlled, phase-3 clinical trial of 3 parallel groups.
- Trial name
- NCT04466007
- Testing
- High dose allogeneic mesenchymal stromal cells, Low dose allogeneic mesenchymal stromal cells
- Where
- 10 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Critical Limb Ischemia, Diabetes
Trial to Assess Chelation Therapy in Critical Limb Ischemia
TACT3a is a double blind, placebo-controlled, randomized trial to test a novel therapy, edetate disodium-based chelation of environmentally acquired toxic metals, to reduce cardiovascular events including amputation in high-risk…
- Trial name
- TACT3a (NCT03982693)
- Testing
- Edetate Disodium
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mt. Sinai Medical Center, Miami
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