Clinical trials: Critical Limb Ischemia
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
Critical Limb Ischemia
Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease
Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study in treating 18 recipients with ischemic limb…
- Trial name
- NCT02336646
- Testing
- Allogenic MSC, Normal saline
- Where
- Taiwan
- Volunteers
- 18 people
- Sponsor
- Taiwan Bio Therapeutics Inc.
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
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
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI).
- Trial name
- REVIVE (NCT01483898)
- Testing
- Ixmyelocel-T
- Where
- 86 sites in United States
- Volunteers
- 41 people
- Sponsor
- Vericel Corporation
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
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
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
Peripheral Arterial Disease, Critical Limb Ischemia
The PRELUDE BTK Study
The objective of the PRELUDE BTK study is to assess safety and efficacy of the Serranator® PTA Serration Balloon Catheter (study device) in subjects with atherosclerotic peripheral artery disease of the infrapopliteal arteries.
- Trial name
- NCT03693963
- Testing
- Serranator
- Where
- 6 sites in Austria, Germany and 2 more
- Volunteers
- 49 people
- Sponsor
- Cagent Vascular LLC
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, 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 Arterial Disease, Critical Limb Ischemia
Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions
The objective of this prospective, non-randomized, multicenter, post-market, observational study is to compile clinical data on percutaneous techniques used to obtain tibiopedal access and to cross infrainguinal arterial…
- Trial name
- NCT01609621
- Testing
- Retrograde tibiopedal arterial access
- Where
- 11 sites in United States, Germany and 1 more
- Volunteers
- 199 people
- Sponsor
- Cook Group Incorporated
Peripheral Vascular Disease, Intermittent Claudication
Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication
The objective is to ensure the pro-active collection of information on quality, safety and performance of FlowOx™ after it is placed on the market.
- Conditions
- Peripheral Vascular Disease, Intermittent Claudication, Walking, Difficulty, Critical Limb Ischemia
- Trial name
- FlowOx (NCT04100681)
- Testing
- Active FlowOx™
- Where
- 5 sites in Germany
- Volunteers
- 16 people
- Sponsor
- Otivio AS
Critical Limb Ischemia
Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.
To evaluate the safety and effectiveness of the Spur System in a patient population with infrapopliteal artery disease (tibioperoneal, anterior/posterior tibial and peritoneal arteries) when used in conjunction with…
- Trial name
- DEEPER (NCT03669458)
- Testing
- Below the Knee peripheral intervention
- Where
- Dominican Republic
- Volunteers
- 21 people
- Sponsor
- ReFlow Medical, 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
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 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
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.
Critical Limb Ischemia
Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT
Using gene therapy to express active telomerase (hTERT) in human cells has the potential to treat many diseases related to aging, including critical limb ischemia (CLI).
- Trial name
- NCT04110964
- Testing
- AAV-hTERT
- Where
- Colombia
- Volunteers
- 5 people
- Sponsor
- Libella Gene Therapeutics
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.