Clinical trials: Critical Ischemia Limb
Peripheral Arterial Disease
Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent to Treat BTK Arteries
The objective of this clinical study is to evaluate the immediate and long-term (up to 12 month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the treatment of patients with critical limb…
- Trial name
- PES-BTK-70 (NCT01630070)
- Testing
- Self-expandable drug eluting stent
- Where
- 5 sites in Belgium
- Volunteers
- 70 people
- Sponsor
- Flanders Medical Research Program
Peripheral Vascular Disease, Intermittent Claudication
Efficacy Study of Iliac Stents to Treat TASC A-B-C-D Iliac Artery Lesions
The BRAVISSIMO trial wants to investigate in a controlled setting, the long-term (up to 24 months) outcome of the self-expanding nitinol Absolute Pro (Abbott Vascular) and the balloon-expandable Omnilink Elite (Abbott Vascular)…
- Conditions
- Peripheral Vascular Disease, Intermittent Claudication, Critical Limb Ischemia
- Trial name
- BRAVISSIMO (NCT00764777)
- Testing
- iliac stenting
- Where
- 5 sites in Belgium
- Volunteers
- 325 people
- Sponsor
- Flanders Medical Research Program
Peripheral Artery Disease, Peripheral Vascular Disease
Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)
The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00951210
- Testing
- PLX-PAD
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Pluristem Ltd.
Critical Lower Limb Ischemia, Type-2 Diabetes Mellitus
Safety and Efficacy Study of Autologous Bone Marrow Aspirate Concentrate for No-Option Critical Limb Ischemia
The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type…
- Trial name
- DIALEG (NCT01818310)
- Testing
- Group A: Intramuscular, Group B: Intraarterial, Group C: Intravenous
- Where
- Czechia
- Volunteers
- 80 people
- Sponsor
- University Hospital Ostrava
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 Artery Disease
Cardiovascular Biomarkers in Peripheral Artery Disease.
Despite the best medical management, many patients with peripheral artery disease (PAD) who undergo lower extremity endovascular revascularization experience adverse cardiovascular outcomes and postoperative complications that…
- Trial name
- NCT05757258
- Where
- Italy
- Volunteers
- 207 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lower Extremity Ischemia, Leg Ulcer
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.
- Conditions
- Lower Extremity Ischemia, Leg Ulcer, Peripheral Vascular Disease, Diabetic Foot
- Trial name
- NCT01903044
- Testing
- BM-MNC injection
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- Pontifícia Universidade Católica do Paraná
Peripheral Arterial Disease, Chronic Limb Threatening Ischemia
Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging
The goal of this observational study is to characterise the relationships between inflammation, microcalcification and thrombus activity in atherosclerotic plaques in peripheral and systemic vascular territories in patients with…
- Trial name
- SISYPHUS (NCT07472049)
- Testing
- Whole body [68Ga]DOTATATE PET-CT, Whole body [18F]GP1 PET-CT, Whole body [18F]NaF PET-CT
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- University of Edinburgh
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
Cardiovascular Disease, Peripheral Artery Disease
Platelet Activity in Vascular Surgery and Cardiovascular Events
Pathological and clinical studies have consistently demonstrated that abnormalities in thrombosis and hemostasis play a major role in the pathogenesis of atherosclerosis and atherothrombosis.
- Conditions
- Cardiovascular Disease, Peripheral Artery Disease, Critical Limb Ischemia
- Trial name
- PACE (NCT02106429)
- Where
- United States
- Volunteers
- 246 people
- Sponsor
- NYU Langone Health
Peripheral Arterial Disease
SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs
A research project capturing experiences of patients with critical limb threatening ischemia, with the ultimate goal of setting new standards for diagnosing, describing detailed patient-centered outcomes, and evaluating the…
- Trial name
- SCOPE-CLI (NCT04710563)
- Where
- United States
- Volunteers
- 458 people
- Sponsor
- Yale University
Peripheral Arterial Disease(PAD), Chronic Limb Threatening Ischemia
Intravascular Ultrasound for Peripheral Artery Disease Revascularization
The purpose of this study is to determine if IVUS use, as compared to angiography alone, prevent major adverse limb events (MALE) or binary restenosis (a greater than 50% re-narrowing of the treated artery) in adult patients who…
- Conditions
- Peripheral Arterial Disease(PAD), Chronic Limb Threatening Ischemia, Intravascular Ultrasound, Major Adverse Limb Events
- Trial name
- CLARITY (NCT06979284)
- Testing
- IVUS-guided strategy
- Where
- 5 sites in Canada
- Volunteers
- 772 people
- Sponsor
- Hamilton Health Sciences Corporation
Critical Limb Ischemia
Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with critical limb ischemia
- Trial name
- NCT01663376
- Testing
- Autologous Adipose Tissue derived MSCs Transplantation
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- R-Bio
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.
Critical Limb Ischemia, Buerger's Disease
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to Buerger's…
- Trial name
- NCT05854615
- Testing
- Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells
- Where
- Malaysia
- Volunteers
- 3 people
- Sponsor
- Cell Biopeutics Resources Sdn Bhd
Peripheral Arterial Disease
Predictive Value of the Global Limb Anatomic Staging System (GLASS) in Patients With Critical Limb-threatening Ischemia
The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) proposes the Global Limb Anatomic Staging System (GLASS), a new angiographic scoring system to quantify the anatomic severity of infrainguinal disease in…
- Trial name
- NCT05999669
- Testing
- GLASS staging
- Volunteers
- 2,000 people
- Sponsor
- RenJi Hospital
Critical Lower Limb Ischemia, Postoperative Complications
Impact of Nutritional and Inflammatory Status in Patients With Critical Limb-threatening Ischemia
The peripheral arterial disease (PAD) has been associated with all-cause and cardiovascular mortality. Despite minimally invasive endovascular techniques, patients with critical limb-threatening ischemia (CLTI) have a poor…
- Trial name
- NCT04756115
- Testing
- Vascular Surgery.
- Where
- Spain
- Volunteers
- 310 people
- Sponsor
- Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Critical Limb Ischemia, Malnutrition
Nutrition in Patient With Critical Limb Ischemia
A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the potential to benefit greatly from…
- Conditions
- Critical Limb Ischemia, Malnutrition, Nutritional Supplements
- Trial name
- NutriVasc (NCT03529019)
- Testing
- Ensure Surgery Immunonutrition Shake, Ensure Enlive Advanced Nutrition Shake
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Boston Medical Center
Chronic Total Occlusion of Artery of the Extremities
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond…
- Trial name
- NCT06492733
- Testing
- FastWire System - Peripheral
- Where
- 6 sites in United States
- Volunteers
- 65 people
- Sponsor
- Versono Medical Ltd
Critical Limb Ischemia
Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.
Clinical trial phase I / II, prospective, multicenter, open, randomized, parallel-groups controlled by two levels of dose to assess the safety and feasibility of the infusion of mesenchymal stem cells from adipose tissue…
- Trial name
- NCT01745744
- Testing
- Mesenchymal stem cells from adipose tissue
- Where
- 2 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud