Clinical trials: Ischemia Limb
Peripheral Arterial Disease (PAD)
Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal…
- Trial name
- UltraFuture I (NCT05498740)
- Testing
- Drug eluting Balloon
- Where
- 24 sites in China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Neurologic Disorder, Paralysis
SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex.
- Conditions
- Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis
- Trial name
- NCT05041114
- Testing
- Motor Neuroprosthesis
- Where
- 3 sites in Australia
- Sponsor
- Synchron Medical, Inc.
Peripheral Artery Disease, Peripheral Vascular Disease
The VaSecure BTK Study
To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Peripheral Arterial Occlusive Disease
- Trial name
- NCT03638115
- Testing
- VaSecure™
- Where
- 7 sites in Belgium, Germany and 1 more
- Volunteers
- 46 people
- Sponsor
- Vascuros Medical Pte Ltd
Critical Limb Ischemia (CLI)
Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System
This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal clinical study in which subjects are evaluated for prevention of major limb amputation in the treatment of non-reconstructable…
- Trial name
- CLIRST III (NCT02538978)
- Testing
- Autologous Bone Marrow Concentrate (aBMC)
- Volunteers
- 224 people
- Sponsor
- Cesca Therapeutics, Inc.
Critical Limb Ischemia (CLI)
IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
A prospective, multi-center, randomized trial to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or…
- Trial name
- GENIUS (NCT04849325)
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™), Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 29 sites in China
- Volunteers
- 120 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Chronic Limb Ischemia
Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Percutaneous Transluminal Angioplasty Revascularization
This is a prospective, multi-center, randomized pilot study to document the effects of adventitial delivery of dexamethasone after balloon angioplasty of lesions below the knee in symptomatic patients with critical limb ischemia…
- Trial name
- LIMBO-PTA (NCT02479555)
- Testing
- Dexamethasone sodium phosphate injection, USP, 4 mg/mL
- Where
- 3 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Mercator MedSystems, Inc.
Critical Limb Ischemia, Peripheral Arterial Disease
IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA
To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the…
- Trial name
- NCT02963649
- Testing
- DCB, PTA
- Where
- 9 sites in Belgium, France and 3 more
- Volunteers
- 50 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 4.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03111238
- Testing
- REX-001
- Where
- 15 sites in Czechia, Germany and 4 more
- Volunteers
- 3 people
- Sponsor
- Ixaka Ltd
Chronic Limb Ischemia
Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee (TANGO)
This is a prospective, multi-center, randomized, dose escalation study to document the effects of adventitial delivery of temsirolimus (Torisel) after revascularization of lesions below the knee in symptomatic patients with…
- Trial name
- TANGO (NCT02908035)
- Testing
- Temsirolimus, Saline
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Mercator MedSystems, Inc.
Peripheral Vascular Diseases
Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia
This is a 15 patient clinical trial assessing the safety and feasibility of using Endometrial Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are not eligible for surgical or catheter-based…
- Trial name
- NCT01558908
- Testing
- Administration of ERC
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Medistem Inc.
Ischemic Stroke
DNS-3379 vs. Placebo in Stroke Rehabilitation
This is a randomized, double-blind, placebo-controlled parallel group outpatient 42-day treatment study that will utilize standard stroke rehabilitation outcome measures to evaluate the effect of DNS-3379 on upper extremity motor…
- Trial name
- SPIRIT (NCT03254160)
- Testing
- DNS-3379
- Where
- 16 sites in Australia, New Zealand
- Volunteers
- 1 people
- Sponsor
- Dart NeuroScience, LLC
Critical Limb Ischemia
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia.
- Trial name
- NCT01064440
- Testing
- Low Dose VM202, High Dose VM202
- Where
- 16 sites in United States, South Korea
- Volunteers
- 52 people
- Sponsor
- Helixmith Co., Ltd.
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.
Peripheral Arterial Disease, Peripheral Vascular Diseases
Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access
This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat subjects with critical limb ischemia (CLI) caused by severe PAD.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Critical Limb Ischemia
- Trial name
- MOBILE-CA (NCT02474121)
- Testing
- Bone marrow concentration device
- Where
- 9 sites in United States
- Sponsor
- Zimmer Biomet
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
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase…
- Conditions
- Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans
- Trial name
- NCT07023965
- Testing
- NL003
- Where
- 5 sites in China
- Volunteers
- 542 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Peripheral Arterial Disease
Evaluation of Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients With Peripheral Arterial Disease
The goal of this clinical trial is to study the safety and tolerability of Etrinabdione in adult patients with peripheral arterial disease. It will also learn about the preliminary efficacy of Etrinabdione.
- Trial name
- CLAUDIA (NCT06774040)
- Testing
- Etribnabdione 25 mg BID, Etribnabdione 50 mg BID
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- VivaCell Biotechnology España
Critical Limb Ischemia (CLI)
Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
A Phase III study of PLX-PAD for CLI patients with minor tissue loss who are unsuitable for revascularization has been initiated (PLX-CLI-03, PACE study).
- Trial name
- NCT03886506
- Testing
- PLX-PAD
- Where
- 2 sites in United States
- Sponsor
- Pluristem Ltd.
Peripheral Arterial Disease, Claudication
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.
- Conditions
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT00883246
- Testing
- SilverHawk & TurboHawk Peripheral Plaque Excision System
- Volunteers
- 800 people
- Sponsor
- Medtronic Endovascular
Stroke, Ischemic, Stroke Hemorrhagic
Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke
A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the Keeogo™ Dermoskeleton in subjects with hemiparesis due to ischemic or hemorrhagic stroke.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Hemiparesis
- Trial name
- NCT03986320
- Testing
- Keeogo™ Dermoskeleton
- Where
- 4 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- B-Temia, Inc.