Clinical trials: Critical Ischemia Limb
Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3)
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)
Prospective, multi-center single-arm observational study A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
- Conditions
- Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3), Critical Limb Ischemia (Rutherford Category 4 or 5)
- Trial name
- NCT03505931
- Testing
- Implantation of Eluvia stent
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yonsei University
Peripheral Arterial Disease, Aortoiliac Occlusive Disease
Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study
Peripheral arterial disease involving the iliac arteries is a common manifestation of systemic atherosclerosis and a major cause of lifestyle-limiting claudication and chronic limb-threatening ischemia.
- Conditions
- Peripheral Arterial Disease, Aortoiliac Occlusive Disease, Chronic Limb-Threatening Ischemia, Intermittent Claudication
- Trial name
- PREMISE-ILIAC (NCT07672249)
- Testing
- Iliac stenting
- Where
- Italy
- Volunteers
- 98 people
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Critical Limb Ischemia
Autologous Stem Cells for the Treatment of No Option Critical Limb Ischemia
The trial is a phase 1b, open label, uncontrolled, non-randomized dose-escalation study of autologous bone marrow-derived MSCs. Following informed consent, patients who meet the criteria will be screened and enrolled.
- Trial name
- NCT03455335
- Testing
- 20 million hMSCs, 40 million hMSCs, 80 million hMSCs
- Where
- Ireland
- Volunteers
- 12 people
- Sponsor
- National University of Ireland, Galway, Ireland
Critical Limb Ischemia
A Safety and Efficacy Study of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia
This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.
- Trial name
- NCT02477540
- Testing
- Cellgram-CLI
- Sponsor
- Pharmicell Co., Ltd.
Critical Limb Ischemia
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation
Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon…
- Trial name
- DEBATE-BTK (NCT01558505)
- Testing
- PEB, POBA
- Where
- Italy
- Volunteers
- 142 people
- Sponsor
- Leonardo Bolognese, MD
Critical Limb Ischemia
Critical Limb Ischemia and Transcutaneous Oximetry
Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns.
- Trial name
- CITRA (NCT04369781)
- Testing
- transcutaneous oxygen pressure recording at rest
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Angers
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
Critical Limb Ischemia, Arterial Occlusive Disease
Safety Study of Adult Stem Cells to Treat Patients With Severe Leg Artery Disease
Peripheral artery disease (PAD) due to leg artery blockages can result in painful leg muscles, skin ulcers and infection due to poor blood flow. In severe forms, the only treatment may be amputation.
- Conditions
- Critical Limb Ischemia, Arterial Occlusive Disease, Vascular Diseases
- Trial name
- SCRIPT-CLI (NCT00913900)
- Testing
- autologous CD133+ cells
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Wisconsin, Madison
Peripheral Artery Disease, Critical Limb Ischemia
Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
The purpose of this study is to evaluate the effectiveness of negative pressure incision management system (Prevena™ Incision Management System (PIMS) or ActiVAC® with the Prevena™ Dressings (Peel and Place™ or Customizable™)…
- Conditions
- Peripheral Artery Disease, Critical Limb Ischemia, Claudication
- Trial name
- NCT02389023
- Testing
- standard gauze dressing, Prevena Incision Management system
- Where
- 5 sites in United States
- Volunteers
- 242 people
- Sponsor
- University of Vermont Medical Center
Lower Limb Ischemia, Peripheral Arterial Disease
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
The SupPORT Registry aims at collecting real-world from Portuguese centers performing femoral-popliteal revascularization with Supera (r) implants. This is a prospective non-randomized non-controlled consecutive registry.
- Conditions
- Lower Limb Ischemia, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Chronic Limb Ischemia
- Trial name
- SupPORT regist (NCT06416644)
- Testing
- Supera Vasculomimetic Stent
- Where
- 15 sites in Portugal
- Volunteers
- 100 people
- Sponsor
- Hospital do Divino Espírito Santo de Ponta Delgada
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
Chronic Limb Threatening Ischemia
Can a Dedicated Chronic Limb-threatening Ischaemia (CLTI) Clinic Improve Patient Self-reported Quality of Life
CLTI is the most severe form of peripheral arterial disease. Patients with the condition require investigation and management (typically in the form of revascularisation surgery) to salvage the limb.
- Trial name
- NCT05613907
- Testing
- CLTI Clinic
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
Peripheral Vascular Diseases, Critical Limb Ischemia
Diamondback in Peripheral Vascular Disease
This is a prospective, nonrandomized, single-arm study using CSI Orbital Atherectomy System in patients with PAD (total occlusions or significant stenosis).
- Trial name
- DIAMOND-PAD (NCT03455374)
- Testing
- Treatment with CSI atherectomy device
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Arkansas Heart Hospital
Peripheral Vascular Diseases, Diabetic Foot
Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia
The aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia.
- Trial name
- NCT00872326
- Testing
- Autologous Bone Marrow Mononuclear Cells
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Andalusian Network for Design and Translation of Advanced Therapies
Peripheral Arterial Disease, Critical Limb Ischemia (CLI)
Pressure (Fractional Flow Reserve) and Flow (Vascular Flow Reserve) Measurements During Peripheral Arterial Interventions
Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) have been originally developed for physiological assessment of coronary artery disease and may hold potential in the management of Peripheral Arterial Disease (PAD) as…
- Trial name
- FLOW-PAD (NCT07052435)
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- Dr. Konstantinos Katsanos
Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
The purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.
- Conditions
- Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Critical Limb-Threatening Ischemia
- Trial name
- Framed IVB (NCT06082466)
- Testing
- FRAMED Infrainguinal Venous Bypass, Conventional Autologous Bypass
- Where
- Austria
- Volunteers
- 110 people
- Sponsor
- Paracelsus Medical University
Critical Limb Ischemia
Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia
This is a randomized and single blinded study aimed to compare the efficacy between intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell implantation and intramuscular autologous bone marrow…
- Trial name
- NCT01456819
- Testing
- Mononuclear and mesenchymal stem cells, Mononuclear cells
- Where
- Malaysia
- Volunteers
- 50 people
- Sponsor
- National University of Malaysia
Peripheral Artery Disease, Critical Limb Ischemia
Complete Lesion Assessment With ffR and IVUS TechnologY
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
- Trial name
- CLARITY I (NCT01941030)
- Testing
- Orbital Atherectomy System, Balloon Angioplasty
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Angioplasty, Critical Lower Limb Ischemia
Outcomes of Straight-line Flow Versus Angiosome-targeted Angioplasty in Treatment of Critical Lower Limb Ischemia
Peripheral arterial disease (PAD) affects more than 200 million people worldwide. Although over 50% are asymptomatic, it accounts for 4% of all amputations.
- Trial name
- NCT06127134
- Testing
- peripheral angioplasty for tibial vessels
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Kafrelsheikh University
Critical Limb Ischemia
Impact of Critical Limb Ischemia on Long Term Cardiac Mortality in Diabetic Patients Undergoing Percutaneous Coronary Revascularization
Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary intervention (PCI) in whom development of critical limb ischemia was prospectively assessed by a dedicated diabetic foot clinic.
- Trial name
- NCT01676519
- Testing
- PCI
- Where
- Italy
- Volunteers
- 764 people
- Sponsor
- Ospedale San Donato