Clinical trials: Chronic Limb Ischemia
Critical Limb Ischemia
Serrantor OCT Study
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
- Trial name
- NCT06434194
- Testing
- Serranator PTA Serration Catheter, PTA (Standard of Care)
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cagent Vascular LLC
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 Vascular Disease
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation.
- Trial name
- NCT00300040
- Testing
- Hemoglobin glutamer 250 - bovine, 6% Hydroxyethylstarch
- Where
- 5 sites in South Africa, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Biopure Corporation
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
Spectroscopic Assessment of Tissue Oxygenation Changes During Vascular Surgery
This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.
- Conditions
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Ischemia Vascular, Tissue Ischemia
- Trial name
- NCT07786623
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Chronic Limb Ischemia, Non-Healing Ulcers
Hyperspectral Imaging Pre and Post Endovascular Intervention
This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.
- Trial name
- CLI-Pre/Post (NCT00768495)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- HyperMed
Peripheral Artery Disease
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia
Non-randomized, multi-center, longitudinal study of healthy subjects and subjects with PAD who are scheduled for ABI, TBI, and either Duplex Ultrasound or Angiographic assessments in a vascular clinic.
- Trial name
- NCT04120610
- Testing
- FlowMet-R, ABI, TBI
- Where
- 5 sites in United States
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- Medtronic Endovascular
Critical Limb Ischemia
A Safety and Efficacy Study of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia
This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.
- Trial name
- NCT02477540
- Testing
- Cellgram-CLI
- Sponsor
- Pharmicell Co., Ltd.
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
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
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
Venous Embolism of Lower Extremities (Diagnosis), Arterial Embolism and Thrombosis
Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
The purpose of Case-Specific Health Care Professional (HCP) Clinical Survey of Liberant™ Thrombectomy System, also known as the Liberant Clinical Assessment, is to collect first-in-human clinical data to confirm the safety and…
- Conditions
- Venous Embolism of Lower Extremities (Diagnosis), Arterial Embolism and Thrombosis, Acute DVT of Lower Extremity, Chronic DVT of Lower Extremity
- Trial name
- NCT07335341
- Testing
- Liberant Thrombectomy System
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Endovascular
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
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.
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
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, 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.
Peripheral Arterial Disease, Critical Limb Ischemia
ACPs in Severe PAD/CLI by Direct Intramuscular Injection
Study title: A Study of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients with Critical Limb Ischemia ( ACPs-CLI ) Principle Investigator: Assoc.Prof. Pramook Mutirangura,M.D.
- Trial name
- NCT00523731
- Testing
- Angiogenic Cell Precursors (ACPs) or Vescell TM
- Where
- Israel
- Volunteers
- 6 people
- Sponsor
- TheraVitae Ltd.
Critical Limb Ischemia, Peripheral Artery Disease
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.
- Trial name
- NCT04304105
- Where
- 25 sites in United States, Puerto Rico
- Volunteers
- 192 people
- Sponsor
- LimFlow, Inc.
Critical Limb Ischemia, Peripheral Artery Disease
Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study
Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from 1.5mm to 4.5mm.
- Trial name
- TOBABTK (NCT02235675)
- Testing
- Tack-It Endovascular System
- Where
- Austria
- Volunteers
- 35 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Critical Limb Ischemia
Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia
The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA.
- Trial name
- DEEPER RCT (NCT06122974)
- Testing
- Drug Eluting Temporary Spur Stent System, Percutaneous Transluminal Balloon Angioplasty
- Volunteers
- 518 people
- Sponsor
- ReFlow Medical, Inc.