Clinical trials: Limb Ischemia
PAD, Infrapopliteal Lesions
European Study of POBA Versus Cotavance(R) Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia (EURO CANAL)
To evaluate the procedural safety and to identify and characterize therapeutic and functional endpoint assessments in subjects with documented critical limb ischemia who received treatment with the Cotavance Paclitaxel-Coated…
- Trial name
- NCT01260870
- Testing
- Cotavance Paclitaxel Coated Balloon, Standard balloon angioplasty
- Where
- 6 sites in Austria, Belgium and 2 more
- Volunteers
- 44 people
- Sponsor
- Bayer
Peripheral Arterial Disease
Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone in Europe
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 (NCT07472439)
- Testing
- Auryon Atherectomy System, Balloon Angioplasty
- Volunteers
- 50 people
- Sponsor
- Angiodynamics, Inc.
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
Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia
This study is designed to evaluate the safety and efficacy of autologous Vascular Repair Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb ischemia.
- Trial name
- RESTORE-CLI (NCT00468000)
- Testing
- Ixmyelocel-T
- Where
- 20 sites in United States
- Volunteers
- 86 people
- Sponsor
- Vericel Corporation
Critical Limb Ischemia
Evaluation of the Tissue Genesis® Icellator Cell Isolation System™ to Treat Critical Limb Ischemia
The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis® Icellator Cell Isolation System™ in Critical Limb Ischemia.
- Trial name
- CLI-DI (NCT02234778)
- Testing
- TGI SVF material via intramuscular injection
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Tissue Genesis
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.
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.
Peripheral Arterial Occlusive Disease, Chronic Limb-Threatening Ischemia
Safety of Antithrombotic Heparin Proteoglycan Mimetic APAC in Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia
The goal of this study is to learn if a new medicine (called antiplatelet and anticoagulant [APAC]) can help the body to prevent blood clots and whether APAC is safe and well tolerated in patients with blocked or narrowed…
- Trial name
- HEALING (NCT07352800)
- Testing
- APAC - dose level 0.50 mg/kg,, Unfractionated heparin (UFH), APAC dose level 1: 0.25 mg/kg,
- Where
- 3 sites in Finland
- Volunteers
- 42 people
- Sponsor
- Aplagon Oy
Critical Limb Ischemia, Peripheral Vascular Disease
Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
The purpose of this research study is to determine if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in the severely diseased…
- Trial name
- mesendo (NCT00518401)
- Testing
- Mesendo
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- TCA Cellular Therapy
Critical Limb Ischemia, Buerger's Disease
A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesenchymal Stem Cells in Patients With Critical Limb Ischemia Due to Buergers Disease
This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy of different doses of Stempeucel in critical limb ischemia patients.
- Trial name
- NCT01484574
- Testing
- Allogeneic Mesenchymal Stem Cells
- Where
- 10 sites in India
- Volunteers
- 90 people
- Sponsor
- Stempeutics Research Pvt Ltd
Critical Limb Ischemia, Peripheral Artery Disease
Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth for the Treatment of Critical Limb Ischemia
MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia
- Trial name
- NCT01351610
- Testing
- PTA + Infusion of MSC_Apceth, PTA
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Apceth GmbH & Co. KG
Critical Limb Ischemia
Safety Study of Gene Therapy in Treating Critical Leg Ischemia
The purpose of this study is to determine the safety, tolerability and preliminary efficacy of intramuscular injections of VM202 for subjects with critical limb ischemia.
- Trial name
- NCT00696124
- Testing
- VM202 2 mg, VM202 4 mg, VM202 8 mg
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Helixmith Co., Ltd.
Critical Limb Ischemia
A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia
Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study
- Trial name
- NCT02974179
- Testing
- Subjects from Study AG-CLI-0206 who received AMG0001
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- AnGes USA, Inc.
Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease
Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.
- Conditions
- Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot
- Trial name
- NCT04267640
- Testing
- AMG0001
- Where
- 20 sites in United States
- Volunteers
- 60 people
- Sponsor
- AnGes USA, Inc.
Critical Limb Ischemia
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.
- Trial name
- ILLUMENATE-BTK (NCT03175744)
- Testing
- Stellarex DCB, PTA Catheter
- Where
- 21 sites in United States, Australia and 3 more
- Volunteers
- 82 people
- Sponsor
- Spectranetics Corporation
Critical Limb Ischemia (CLI)
LIFE-BTK Randomized Controlled Trial
The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed…
- Trial name
- LIFE-BTK (NCT04227899)
- Testing
- Esprit BTK Device, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 50 sites in United States, Australia and 4 more
- Volunteers
- 261 people
- Sponsor
- Abbott Medical Devices
Diabetic Foot Ulcer
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT06437028
- Testing
- Dual-layer perinatal tissue allograft, Three-layer fenestrated perinatal tissue allograft, Standard of care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Samaritan Biologics
Chronic Limb-Threatening Ischemia
Esprit BTK Post-Approval Study
The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients…
- Trial name
- EspritBTKPAS (NCT06656364)
- Testing
- Esprit BTK System
- Where
- 39 sites in United States, Hong Kong and 2 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
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.
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