Clinical trials: Ischemia Limb
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
Thrombolysis
CaveoVasc Thrombolysis Protection System, Access Protection Study
The CaveoVasc Thrombolysis Protection System is intended to aid sheath access and reduce bleeding complications during catheter directed thrombolysis (CDT) in the treatment of limb ischemia.
- Trial name
- NCT03166059
- Testing
- CaveoVasc® Thrombolysis Protection System
- Volunteers
- 20 people
- Sponsor
- CaveoMed GmbH
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
Peripheral Vascular Disease
Prostaglandin E1 (Liprostin) Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within…
- Trial name
- NCT00053716
- Testing
- Liprostin [liposomal Prostaglandin E1]
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Endovasc
Critical Limb Ischemia, Severe Leg Ischemia
Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of…
- Conditions
- Critical Limb Ischemia, Severe Leg Ischemia, Peripheral Artery Disease, Peripheral Vascular Disease
- Trial name
- MESENDO (NCT00721006)
- Testing
- MESENDO
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- TCA Cellular Therapy
Ischemic Stroke
HT-3951 vs. Placebo in Stroke Rehabilitation
This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect…
- Trial name
- RESTORE (NCT02530307)
- Testing
- HT-3951
- Where
- 18 sites in United States
- Volunteers
- 61 people
- Sponsor
- Dart NeuroScience, LLC
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 Artery Disease
Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair
The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the…
- Trial name
- NCT02044003
- Testing
- Innovasc Tack Intravascular Staple System (Tack)
- Where
- 2 sites in Paraguay
- Volunteers
- 11 people
- Sponsor
- Philips Clinical & Medical Affairs Global
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 (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
Arterial Occlusive Disease, Ischemia
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-1)
To evaluate the safety and efficacy of recombinant human hepatocyte growth factor (HGF) bare plasmid injection for local intramuscular injection in the treatment of patients with severe lower limb hemorrhagic disease (Rutherford…
- Conditions
- Arterial Occlusive Disease, Ischemia, Ulcers, Peripheral Vascular Disease
- Trial name
- NCT04275323
- Testing
- NL003, Normal Saline
- Where
- 13 sites in China
- Volunteers
- 302 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Acute Peripheral Arterial Occlusion
A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion
The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing different delivery regimens in patients with peripheral arterial occlusion.
- Trial name
- NCT01222117
- Testing
- Plasmin, Plasminogen Activator
- Where
- 39 sites in United States, Belgium and 10 more
- Volunteers
- 174 people
- Sponsor
- Grifols Therapeutics LLC
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.
Critical Limb Ischemia, Ischemia
HemaTrate™ in the Treatment of Critical Limb Ischemia
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia.
- Trial name
- NCT03809494
- Testing
- HemaTrate™ Blood Filtration system, Saline
- Where
- 3 sites in United Kingdom
- Volunteers
- 2 people
- Sponsor
- Cook Research Incorporated
Peripheral Vascular Disease
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is designed to assess the efficacy and safety of the…
- Trial name
- NCT00059657
- Testing
- Ecraprost in lipid emulsion
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 280 people
- Sponsor
- Tanabe Pharma Corporation
Arterial Occlusive Disease, Ulcers
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
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, Ulcers, Ischemia, Peripheral Vascular Disease
- Trial name
- NL003CLI-II (NCT01548378)
- Testing
- NL003, Normal Saline
- Where
- 9 sites in China
- Volunteers
- 200 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Critical Limb Ischemia
ACP-01 in Patients With Critical Limb Ischemia
The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of…
- Trial name
- NCT02551679
- Testing
- ACP-01
- Where
- 19 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- Hemostemix
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, Buerger Disease
Study to Assess the Efficacy and Safety of CLBS12 in Patients with Critical Limb Ischemia (CLI)
A prospective, open label, controlled, randomized, double arm, multi-center study to assess the efficacy and safety of CLBS12 in patients with critical limb ischemia (CLI) due to arteriosclerosis obliterans (ASO) with a single…
- Conditions
- Critical Limb Ischemia, Buerger Disease, Thromboangiitis Obliterans, Atherosclerosis Obliterans
- Trial name
- NCT02501018
- Testing
- CLBS12, SOC
- Where
- 12 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Lisata Therapeutics, Inc.
Critical Limb Ischemia
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
- Trial name
- NCT01870401
- Testing
- Lutonix DCB, Uncoated PTA Catheter
- Where
- 51 sites in United States, Austria and 6 more
- Volunteers
- 442 people
- Sponsor
- C. R. Bard