Clinical trials: Ischemia Limb
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Neuropathy;Peripheral, Limb Ischemia
Feasibility and Clinical Utility of Paired Non-Invasive Hemodynamic and Tissue Oximetry Monitoring to Detect Limb Ischemia in Lithotomy-Positioned Surgeries
The LIMB Study is a prospective, observational pilot study evaluating the feasibility of combined non-invasive hemodynamic and lower-limb tissue oximetry monitoring during prolonged minimally invasive pelvic surgeries performed…
- Trial name
- LIMB (NCT07387653)
- Testing
- Lower-Extremity Perfusion Monitoring
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Stable Coronary Artery Disease, Acute Coronary Syndromes
Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease
Numerous clinical studies have highlighted the role of macrophages in the destabilization of coronary lesions; however, there is limited literature on the relationship between circulating monocytes and intraplaque macrophages.
- Conditions
- Stable Coronary Artery Disease, Acute Coronary Syndromes, Critical Limb Ischemia, Intermittent Claudication
- Trial name
- NCT07588295
- Testing
- Optical Coherence Tomography assessment
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Maria Cecilia Hospital
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
SELUTION4BTK Trial
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in…
- Trial name
- NCT05055297
- Testing
- SELUTION SLR™ DEB 014, Plain (Uncoated) Balloon Angioplasty (PTA)
- Where
- 48 sites in United States, Austria and 8 more
- Volunteers
- 376 people
- Sponsor
- M.A. Med Alliance S.A.
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
- Conditions
- Critical Limb Ischemia, Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
- Trial name
- NCT05313165
- Testing
- LimFlow Stent Graft System
- Where
- 30 sites in United States
- Volunteers
- 100 people
- Sponsor
- LimFlow, Inc.
Upper Limb Ischemia
Evolution of the Patient's Perception of the Use of the Upper Limb After a Stroke During Intensive Rehabilitation
This study is being carried out in the context of rehabilitation after stroke, where persistent upper limb weakness is a major challenge.
- Trial name
- ValetM-2024 (NCT06569771)
- Testing
- Functional assessments
- Where
- 2 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Grand Hôpital de Charleroi
Peripheral Arterial Occlusive Disease, Chronic Limb-Threatening Ischemia
Safety of Antithrombotic Heparin Proteoglycan Mimetic APAC in Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia
The goal of this study is to learn if a new medicine (called antiplatelet and anticoagulant [APAC]) can help the body to prevent blood clots and whether APAC is safe and well tolerated in patients with blocked or narrowed…
- Trial name
- HEALING (NCT07352800)
- Testing
- APAC - dose level 0.50 mg/kg,, Unfractionated heparin (UFH), APAC dose level 1: 0.25 mg/kg,
- Where
- 3 sites in Finland
- Volunteers
- 42 people
- Sponsor
- Aplagon Oy
Chronic Limb-Threatening Ischemia
Woundsome Revascularization in Chronic Limb-Threatening Ischemia
Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease and remains a major health problem.
- Trial name
- NCT07488637
- Testing
- Revascularization by Percutaneous Transluminal Angioplasty
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Assiut University
Arteriosclerosis, Peripheral Artery Disease
Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
This study is a multicenter observational study designed to evaluate the the effectiveness and safety of drug-coated balloon (DCB) angioplasty for below the knee arterial lesions in patients critical with Limb Threatening…
- Conditions
- Arteriosclerosis, Peripheral Artery Disease, Chronic Limb Threatening Ischemia
- Trial name
- Act (NCT05620095)
- Testing
- drug-coated balloon
- Where
- 10 sites in China
- Volunteers
- 1,000 people
- Sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Chronic Limb-Threatening Ischemia
Esprit BTK Post-Approval Study
The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients…
- Trial name
- EspritBTKPAS (NCT06656364)
- Testing
- Esprit BTK System
- Where
- 39 sites in United States, Hong Kong and 2 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease, Critical Limb-Threatening Ischemia
Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia
The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI.
- Conditions
- Peripheral Arterial Disease, Critical Limb-Threatening Ischemia, Diabetic Foot
- Trial name
- PiPER (NCT06277362)
- Where
- 9 sites in Italy
- Volunteers
- 50 people
- Sponsor
- EndoCore Lab s.r.l.
Failed Back Surgery Syndrome, Limb Ischemia
Evaluation of Online Tool (E-TOOL SCS) in Spinal Cord Stimulaion
This observational multicenter study aims to evaluate the reliability and validity of the e-tool for selecting patients eligible for SCS for chronic pain caused by one of the four etiologies listed above in the experience of…
- Conditions
- Failed Back Surgery Syndrome, Limb Ischemia, Neuropathic Pain, Complex Regional Pain Syndromes
- Trial name
- E-TOOLSCS (NCT06229015)
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
Peripheral Artery Disease (PAD), Femoropopliteal Artery Disease
Chocolate Balloon vs Standard Balloon Angioplasty Before Drug-Coated Balloon Treatment for Femoropopliteal Artery Narrowing or Blockage
The goal of this clinical trial is to learn if using the Chocolate Percutaneous Transluminal Angioplasty (PTA) balloon for vessel preparation improves outcomes before drug-coated balloon (DCB) treatment in patients with…
- Conditions
- Peripheral Artery Disease (PAD), Femoropopliteal Artery Disease, Vascular Lesion Preparation, Critical Limb-Threatening Ischemia
- Trial name
- CHOICE (NCT07471087)
- Testing
- Chocolate PTA Balloon, Standard Balloon Angioplasty (POBA)
- Volunteers
- 242 people
- Sponsor
- Felice Pecoraro
Renal Impairment, Limb Ischemia, Critical
Ultra-low Dose Contrast for Endovascular Procedures
The purpose of this protocol is to study the safety and feasibility of using ultra-low dose iodinated contrast agent for infrainguinal endovascular revascularization procedures in patients with chronic limb-threatening lower limb…
- Trial name
- ULTRA-LOW (NCT06835127)
- Testing
- Infrainguinal peripheral endovascular revascularization
- Where
- Greece
- Volunteers
- 18 people
- Sponsor
- Attikon Hospital
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
Structured Educational Program vs Standard Care in Pre-surgical Critical Limb Ischemia Patients
Critical limb ischemia (CLI) is a severe condition where poor blood flow to the legs causes pain, non-healing wounds, and may require amputation. It affects 10% of people over 40, rising to 20% in those over 70.
- Conditions
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Health Education
- Trial name
- NCT07201168
- Testing
- Structured Multimodal Educational Program for Critical Limb Ischemia, Standard medical care
- Where
- Kazakhstan
- Volunteers
- 184 people
- Sponsor
- Tulip Medicine
Cardiac Surgery, Ischemia Limb
Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach
This is a first-in-human, prospective, single-arm, phase I clinical study evaluating the safety of the iPerf femoral arterial cannula in patients undergoing planned cardiac surgery requiring extracorporeal circulation (ECC) via a…
- Trial name
- FIH IPERF-01 (NCT07163234)
- Testing
- Cardiac surgery
- Where
- 2 sites in France
- Volunteers
- 15 people
- Sponsor
- IPERF SAS
Limb Injury, Limb Ischemia
The Effect of Emotional Freedom Technique on Patients Receiving Preventive Foot Care
It is planned to examine the effect of the emotional liberation technique on the anxiety level in patients who receive preventive foot wound care and treatment in the postoperative period.
- Conditions
- Limb Injury, Limb Ischemia, Complication Diabetic, Complication,Postoperative
- Trial name
- NCT07066371
- Testing
- Emotional freedom technique
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Bitlis Eren University
Chronic Limb-Threatening Ischemia
Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions.
- Trial name
- ELITE-BTK (NCT06071429)
- Testing
- MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA)
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- R3 Vascular Inc.
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, Tibialis Vessels Occlusion
Single Versus Multiple Vessels Endovascular Tibial Arteries Revascularization for Critical Limb Ischemia
This study aims to Compare the outcomes of angioplasty for single tibial vessel occlusion versus multiple tibial vessel occlusions in patients with critical limb ischemia.
- Trial name
- NCT07383064
- Testing
- Endovascular Revascularization
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Aswan University