Clinical trials: Limb Ischemia
Peripheral Arterial Disease
HORIZON Prospective Clinical Investigation
The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX \& PULL in a prospective investigation for the treatment of…
- Trial name
- NCT05234164
- Testing
- EXIST 6F NiTi Stent System FLEX, EXIST 6F NiTi Stent System PULL
- Where
- 2 sites in Italy, Poland
- Volunteers
- 69 people
- Sponsor
- Qmedics AG
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
Peripheral Arterial Disease
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the…
- Trial name
- Axys ACHIEVE (NCT04282161)
- Testing
- Axys EX device
- Sponsor
- Medtronic Endovascular
Lower Extremity Acute Limb Ischemia, LE ALI
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
- Trial name
- STRIDE II (NCT06747117)
- Testing
- Indigo Aspiration System
- Where
- 45 sites in United States, Australia and 5 more
- Volunteers
- 300 people
- Sponsor
- Penumbra Inc.
Critical Limb Ischemia
The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs.
- Trial name
- SAVAL (NCT03551496)
- Testing
- Drug Eluting Stent - Below the Knee, Standard PTA Control Arm
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 201 people
- Sponsor
- Boston Scientific Corporation
Acute Limb Ischemia, Arterial Occlusion Mesenteric Artery Superior
Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe…
- Conditions
- Acute Limb Ischemia, Arterial Occlusion Mesenteric Artery Superior, Acute DVT of Lower Extremity
- Trial name
- JapanIndigoPMS (NCT06446024)
- Testing
- Mechanical aspiration thrombectomy
- Where
- Japan
- Volunteers
- 500 people
- Sponsor
- Penumbra Inc.
Critical Limb Ischemia
Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Critical Limb Ischemia
The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain…
- Trial name
- NCT06359912
- Testing
- EPCs, Clinical standard treatment (CST)
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Allife Medical Science and Technology Co., Ltd.
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
Critical Limb Ischemia
MOTIV BTK Randomized Controlled Trial
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
- Trial name
- NCT05406622
- Testing
- MOTIV Sirolimus-Eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 26 sites in United States, Germany
- Volunteers
- 292 people
- Sponsor
- REVA Medical, Inc.
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
Acute Lower Limb Arterial Occlusion
The ArtixASCEND Study
This study is a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
- Trial name
- NCT07135895
- Testing
- Artix Thrombectomy System
- Where
- 23 sites in United States
- Volunteers
- 250 people
- Sponsor
- Inari Medical
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
Critical Limb Ischemia (CLI)
Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects…
- Trial name
- NCT03006770
- Testing
- PLX-PAD
- Where
- 57 sites in United States, Bulgaria and 7 more
- Volunteers
- 213 people
- Sponsor
- Pluristem Ltd.
Ischemic Stroke, Upper Extremity Problem
VNS-REHAB At-Home - Post-Market Study for Using the Vivistim System® at Home
This is a single-arm post-market study of up to 150 participants, using up to 50 mobile therapists to conduct up to 36-hours at-home therapy.
- Trial name
- AT-HOME (NCT05691023)
- Testing
- Vivistim System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- MicroTransponder Inc.
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
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03174522
- Testing
- REX-001
- Where
- 15 sites in Czechia, Hungary and 4 more
- Volunteers
- 49 people
- Sponsor
- Ixaka Ltd
Peripheral Arterial Disease, Critical Limb Ischemia
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)
This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).
- Trial name
- DEEPER REVEAL (NCT05358353)
- Testing
- Bare Temporary Spur Stent System
- Where
- 48 sites in United States
- Volunteers
- 130 people
- Sponsor
- ReFlow Medical, Inc.
Critical Limb Ischemia (CLI)
Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)
This is an Expanded Access program (EAP), sponsored by WideTrial for the treatment of critical limb ischemia (CLI). Widetrial, an Expanded Access specialist, has arranged to supply participating sites with PLX-PAD for CLI…
- Trial name
- NCT03746899
- Testing
- PLX-PAD
- Sponsor
- WideTrial, Inc.
Chronic Limb-Threatening Ischemia
AcoArt Litos PCB Below-the-knee Global Trial
The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of…
- Trial name
- NCT06330493
- Testing
- PCB, PTA
- Where
- 18 sites in United States, Austria and 1 more
- Volunteers
- 75 people
- Sponsor
- Acotec Scientific Co., Ltd
PAOD - Peripheral Arterial Occlusive Disease, PAD
Recombinant SeV-hFGF2/dF Injection for PAOD
Lower extremity arteriosclerosis obliterans is due to the formation of atherosclerotic plaque in the lower extremities, resulting in the stenosis and occlusion of the artery, leading to chronic ischemia of the limbs.
- Conditions
- PAOD - Peripheral Arterial Occlusive Disease, PAD, Critical Limb Ischemia
- Trial name
- NCT03668353
- Testing
- Recombinant SeV-hFGF2/dF Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.