Clinical trials: Ischemia Limb
Percutaneous Transluminal Angioplasty, Atherosclerosis of Arteries of the Extremities, Unspecified
Skin Microcirculation in Patients With Lower Limb Atherosclerosis
The aim of this study is to explore the ability of the non-invasive device ODI-Tech® to monitor changes in microvascular blood flow in patients with lower limb ischemia undergoing the procedure percutaneous transluminal…
- Trial name
- SMILLA (NCT07312383)
- Testing
- Examination with the ODI-Tech medical device
- Where
- Norway
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ODI Medical AS
Critical Limb Ischemia
To Evaluate the Safety and Efficacy of IM and IV Administration of Autologous ADMSCs for Treatment of CLI
Various preclinical animal studies have shown the potential of stem cells in re-vascularising ischemic limbs and promoting collateral vessel formation.
- Trial name
- NCT02145897
- Testing
- Autologous Stromal Vascular Fraction (SVF), Autologous Adipose Derieved MSCs, Control
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Kasiak Research Pvt. Ltd.
Acute Limb Ischemia
Thrombolysis With Recombinant Non-immunogenic Staphylokinase vs Surgery in Patients With Acute Limb Ischemia FORAT Trial
Objective: to evaluate the efficacy and safety of intra-arterial intrathrombus administration of the recombinant non-immunogenic staphylokinase (Fortelyzin®) in patients with acute limb ischemia (ALI) vs surgery.
- Trial name
- FORAT (NCT05372718)
- Testing
- Recombinant non-immunogenic staphylokinase (Fortelyzin®), surgical methods of treatment
- Where
- 8 sites in Russia
- Volunteers
- 170 people
- Sponsor
- Supergene, LLC
Peripheral Artery Disease, Critical Limb Ischemia
Complete Lesion Assessment With ffR and IVUS TechnologY
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
- Trial name
- CLARITY I (NCT01941030)
- Testing
- Orbital Atherectomy System, Balloon Angioplasty
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia
Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores…
- Trial name
- NCT01245335
- Testing
- BMAC injection
- Where
- 34 sites in United States
- Volunteers
- 97 people
- Sponsor
- Harvest Technologies
Diabetic Foot, Critical Limb Ischemia
A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
The purpose of this study is to determine whether the method (implanting stem cells derived from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the management of diabetic foot ischemia, the…
- Conditions
- Diabetic Foot, Critical Limb Ischemia, Leg Ulcers
- Trial name
- NCT00922389
- Testing
- will receive G-CSF and peripheral blood derived mononuclear cells, G-CSF, Standard Therapy
- Where
- India
- Volunteers
- 36 people
- Sponsor
- Beike Biotech India Pvt.ltd
Stroke, Upper Extremity Paresis
Pilot/Pivotal Study of DBS+Rehab After Stroke
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
- Trial name
- RESTORE (NCT05701280)
- Testing
- Deep Brain Stimulation, Rehabilitation
- Where
- 9 sites in United States
- Volunteers
- 202 people
- Sponsor
- Enspire DBS Therapy, Inc.
Peripheral Arterial Disease, Critical Limb Ischemia
BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI
The purpose of this study is to determine if an MRI technique called Blood Oxygen Level Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment with standard endovascular therapy in patients…
- Trial name
- NCT02601430
- Testing
- BOLD-MRI
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Zimmer Biomet
Acute Lower Limb Arterial Occlusion
The ArtixASCEND Study
This study is a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
- Trial name
- NCT07135895
- Testing
- Artix Thrombectomy System
- Where
- 23 sites in United States
- Volunteers
- 250 people
- Sponsor
- Inari Medical
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
Chronic Limb Ischemia
Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Atherectomy (ATX)-Based Revascularization
This is a prospective, multi-center, randomized pilot study to document the effects of adventitial delivery of dexamethasone after atherectomy-based revascularizations of lesions below the knee in symptomatic patients with…
- Trial name
- LIMBO-ATX (NCT02479620)
- Testing
- Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL
- Where
- 10 sites in United States
- Volunteers
- 120 people
- Sponsor
- Mercator MedSystems, Inc.
Critical Limb Ischemia
Percutaneous Deep Vein Arterialization Post-Market Study
The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.
- Trial name
- PROMISE UK (NCT03807661)
- Testing
- Percutaneous deep vein arterialization, LimFlow System
- Where
- 6 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- LimFlow SA
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.
Lower Extremity Acute Limb Ischemia, LE ALI
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
The primary objective of this study is to collect safety and performance data on the Indigo Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
- Trial name
- STRIDE (NCT04144959)
- Testing
- Indigo Aspiration System
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 119 people
- Sponsor
- Penumbra Inc.
Peripheral Arterial Diseases
Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone
The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages.
- Trial name
- AMBITION BTK (NCT06777901)
- Testing
- Auryon Atherectomy System, Balloon Angioplasty
- Where
- 9 sites in United States
- Volunteers
- 224 people
- Sponsor
- Angiodynamics, Inc.
Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury
Research on Wireless Brain Implant System for General Control of External Devices
The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive…
- Conditions
- Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury, Brainstem Stroke, Amyotrophic Lateral Sclerosis
- Trial name
- RISE (NCT06829212)
- Testing
- WRS
- Where
- China
- Volunteers
- 4 people
- Sponsor
- Shanghai StairMed Technology Co., Ltd.
Chronic Limb-Threatening Ischemia
Peripheral Bypass Trial for Completion Control
The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle
- Trial name
- PATENT (NCT06264843)
- Testing
- MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- Medistim ASA
Acute Limb Ischemia
Evaluation of MST-188 in Acute Lower Limb Ischemia
The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether treatment with MST-188 results in more rapid…
- Trial name
- NCT02093468
- Testing
- MST-188, Saline
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- Mast Therapeutics, Inc.
Upper Extremity Problem
Vivistim Registry for Paired VNS Therapy (GRASP)
The purpose of the Vivistim Registry for Paired VNS Therapy (GRASP) is to gather real-world information on patients with arm and hand deficits post-stroke who are considering Vivistim System treatment.
- Trial name
- GRASP (NCT05301140)
- Testing
- Vivistim System
- Where
- 16 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- MicroTransponder Inc.
Peripheral Arterial Occlusion or Emboli
Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or…
- Trial name
- PRISM (NCT02085551)
- Testing
- Mechanical Thrombectomy by the Indigo System
- Where
- 5 sites in United States
- Volunteers
- 85 people
- Sponsor
- Penumbra Inc.