Clinical trials: Lower Limb Ischemia
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 (STRIDE II)
The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
- Trial name
- STRIDE II (NCT06747117)
- Testing
- Indigo Aspiration System
- Where
- 45 sites in United States, Australia and 5 more
- Volunteers
- 300 people
- Sponsor
- Penumbra Inc.
Acute Limb Ischemia, Arterial Occlusion Mesenteric Artery Superior
Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe…
- Conditions
- Acute Limb Ischemia, Arterial Occlusion Mesenteric Artery Superior, Acute DVT of Lower Extremity
- Trial name
- JapanIndigoPMS (NCT06446024)
- Testing
- Mechanical aspiration thrombectomy
- Where
- Japan
- Volunteers
- 500 people
- Sponsor
- Penumbra Inc.
Critical Limb Ischemia
Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Critical Limb Ischemia
The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain…
- Trial name
- NCT06359912
- Testing
- EPCs, Clinical standard treatment (CST)
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Allife Medical Science and Technology Co., Ltd.
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
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
Lower Limb Ischaemia
Nasal High Flow Oxygen in Patients With Lower-Limb Ischaemia
A prospective, single arm pilot efficacy study designed to evaluate the physiological and symptomatic effects of normobaric Nasal High Flow (NHF) oxygen therapy in patients with lower limb ischaemia experiencing rest pain and/or…
- Trial name
- NCT07891208
- Testing
- Nasal high flow oxygen
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Critical Limb Ischemia, Peripheral Arterial Disease
ALD-301 for Critical Limb Ischemia, Randomized Trial
This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLI-001 (NCT00392509)
- Testing
- ALDH-br bone marrow cells vs. mononuclear bone marrow cells
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Aldagen
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.
Peripheral Arterial Disease, Critical Lower Limb Ischemia
Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon
To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.
- Trial name
- SWING (NCT04107298)
- Testing
- SUNDANCE™ Drug Coated Balloon
- Where
- 8 sites in Australia, Austria and 3 more
- Volunteers
- 35 people
- Sponsor
- SurModics, Inc.
Critical Limb-Threatening Ischemia, Critical Limb Ischemia
Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia
The objective of this prospective, multi-center, clinical investigation is to evaluate the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions.
- Conditions
- Critical Limb-Threatening Ischemia, Critical Limb Ischemia, Critical Lower Limb Ischemia
- Trial name
- MAGNITUDE-BTK (NCT06075940)
- Testing
- MAGNITUDE BRS
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- R3 Vascular Inc.
Diabetic Foot Ulcer (DFU)
Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers
The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT07290673
- Testing
- FoundationDRS Solo, Standard of Care
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Samaritan Biologics
Critical Lower Limb Ischemia
Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia
This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels.
- Trial name
- INPACT-DEEP (NCT00941733)
- Testing
- IN.PACT Amphirion, Standard PTA
- Where
- 13 sites in Austria, Belgium and 4 more
- Volunteers
- 358 people
- Sponsor
- Medtronic Endovascular
Atherosclerosis, Peripheral Artery Disease
The ABSORB BTK (Below The Knee) Clinical Investigation
The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with critical limb ischemia (CLI) following…
- Conditions
- Atherosclerosis, Peripheral Artery Disease, Peripheral Vascular Disease, PAD
- Trial name
- NCT01341340
- Testing
- Everolimus Eluting BVS
- Where
- Belgium
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
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.
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.
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
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Wound Healing
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
This is a randomized, placebo-controlled, single-blind (subjects and investigators will be blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part B) trial in healthy volunteers and subjects…
- Trial name
- NCT01831804
- Testing
- GSK1278863
- Where
- 7 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Critical Limb Ischemia
Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for…
- Trial name
- NCT02099500
- Testing
- Liposuction, Stem Cell Injection
- Where
- United States
- Sponsor
- Ageless Regenerative Institute
Peripheral Arterial Disease, Atherosclerotic Lesion
Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease
This first-in-human clinical feasibility study will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold and Delivery System in patients undergoing treatment for peripheral…
- Conditions
- Peripheral Arterial Disease, Atherosclerotic Lesion, Lower Extremity Ischemia, Lower Extremity Claudication
- Trial name
- RESOLV I (NCT04912323)
- Testing
- Percutaneous Implantation of the MAGNITUDE® Bioresorbable Arterial Scaffold
- Where
- 7 sites in Austria, Canada and 1 more
- Volunteers
- 30 people
- Sponsor
- R3 Vascular Inc.