Clinical trials: Critical Ischemia Limb
Critical Limb Ischemia, Peripheral Arterial Disease
Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization
The objective Study is to evaluate the short- and long-term clinical outcomes of patients receiving the CryoVein cryopreserved saphenous vein allograft (CVA) as their primary open bypass conduit to assess if there is a…
- Trial name
- LIMBSAVE (NCT01799811)
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- CryoLife, Inc.
Peripheral Arterial Disease, Claudication
Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
The Phoenix Post-Approval Registry is a prospective, multi-center, single arm registry sponsored by Volcano Corporation to evaluate the short and long term performance and clinical outcomes of the Phoenix Atherectomy System.
- Conditions
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT02475200
- Testing
- Atherectomy
- Where
- 5 sites in United States
- Volunteers
- 500 people
- Sponsor
- Volcano Corporation
Peripheral Arterial Disease, Critical Limb Ischemia
A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base DCB
This is a non-randomized, prospective, single center pilot study designed to evaluate the safety of the Temporary Spur Stent System to treat patients with infrapopliteal arterial disease, when used in conjunction with a…
- Trial name
- DEEPER LIMUS (NCT04162418)
- Testing
- Temporary Spur Stent System
- Where
- Austria
- Volunteers
- 26 people
- Sponsor
- ReFlow Medical, Inc.
Critical Limb Ischemia
Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia
Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.
- Trial name
- AGILITY (NCT02144610)
- Testing
- HGF Plasmid (AMG0001)
- Where
- 60 sites in United States, Belgium and 9 more
- Volunteers
- 46 people
- Sponsor
- AnGes USA, Inc.
Chronic Limb-Threatening Ischemia
Peripheral Bypass Trial for Completion Control
The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle
- Trial name
- PATENT (NCT06264843)
- Testing
- MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- Medistim ASA
Peripheral Arterial Disease, Critical Lower Limb Ischemia
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
- Trial name
- HEAL (NCT04110327)
- Testing
- MicroStent
- Where
- 10 sites in Austria, Belgium and 3 more
- Volunteers
- 300 people
- Sponsor
- Micro Medical Solution, Inc.
Ischemia, Peripheral Arterial Disease
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)
- Conditions
- Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases
- Trial name
- NCT02044666
- Testing
- Micronized Small Intestinal Submucosa (SIS)
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Cook Group Incorporated
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
Peripheral Arterial Disease, Peripheral Vascular Disease
Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the safety and activity of two doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with chronic critical limb…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00956332
- Testing
- MultiGeneAngio
- Where
- 7 sites in Israel
- Volunteers
- 28 people
- Sponsor
- MultiGene Vascular Systems Ltd.
Critical Limb Ischemia, Peripheral Arterial Disease
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- MOBILE (NCT01049919)
- Testing
- Bone marrow concentration device
- Where
- 25 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Critical Limb Ischemia
A Safety and Tolerability Study of RJX Drug Product in Healthy Participants
Designed as a single center, two-part, double-blind, placebo-controlled, randomized study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RJX in healthy participants.
- Trial name
- NCT03680105
- Testing
- RJX
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Reven Pharmaceuticals, Inc.
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
Critical Limb Ischemia, Vascular Diseases
A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia
The purpose of the study is to confirm the feasibility of study procedures and the tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)
- Conditions
- Critical Limb Ischemia, Vascular Diseases, Peripheral Arterial Disease
- Trial name
- NCT02016755
- Testing
- HGF Plasmid
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- AnGes USA, Inc.
Critical Limb Ischemia
YQ23 Study in Patients With Critical Limb Ischaemia
This is an early phase study to assess how safe and tolerable is the new study drug YQ23 and to compare the effectiveness of YQ23 against normal saline to treat critical limb ischaemia.
- Trial name
- YAN (NCT04792008)
- Testing
- YQ23
- Where
- 2 sites in Hong Kong
- Volunteers
- 5 people
- Sponsor
- New Beta Innovation Limited
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.
Peripheral Arterial Disease, Critical Limb Ischemia
BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI
The purpose of this study is to determine if an MRI technique called Blood Oxygen Level Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment with standard endovascular therapy in patients…
- Trial name
- NCT02601430
- Testing
- BOLD-MRI
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Zimmer Biomet
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.
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