Clinical trials: Lower Extremity Ischemia
Critical Leg Ischemia
Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia (CLI)
This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al.
- Trial name
- NCT00377897
- Testing
- cell therapy
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University of Paris 5 - Rene Descartes
Chronic Threatening Lower Limb Ischemia
Duplex Ultrasound Versus Conventional Angiography in Evaluating Lower Limb Threatening Ischemia
This study aims to evaluate the accuracy of Duplex Ultrasound (DUS) in assessing infra inguinal arterial lesions in patients with chronic threatening limb ischemia compared with digital subtraction angiography (DSA) as the…
- Trial name
- DUS-CTA (NCT07113197)
- Testing
- conventional angiography
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Sohag University
Hypertension, Dementia
BedMed-Frail: Does the Potential Benefit of Bedtime Antihypertensive Prescribing Extend to Frail Populations?
High blood pressure (present in 1 of 5 Canadian adults) increases the risk of heart attack and stroke. Blood pressure lowering pills reduce this risk - but perhaps not optimally.
- Trial name
- NCT04054648
- Testing
- Bedtime administration of the participant's pre-existing antihypertensive medications
- Where
- Canada
- Volunteers
- 776 people
- Sponsor
- University of Alberta
Critical Limb Ischemia, Diabetic Foot
Autologous Peripheral Blood Mononuclear Cells in Diabetic Foot Patients With No-option Critical Limb Ischemia
The objective of this trial is to determine whether PBMNCs in diabetic patients with critical, non revascularizable limb ischemia can prevent major amputation and affect mortality and healing.
- Trial name
- NCT04255004
- Testing
- Pall Celeris System, point of care device for human cell therapy
- Volunteers
- 76 people
- Sponsor
- Ospedale San Donato
Critical Lower Limb Ischemia
Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia
This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels.
- Trial name
- INPACT-DEEP (NCT00941733)
- Testing
- IN.PACT Amphirion, Standard PTA
- Where
- 13 sites in Austria, Belgium and 4 more
- Volunteers
- 358 people
- Sponsor
- Medtronic Endovascular
Diabetic Foot, Arterial Occlusive Disease
Urokinase Therapy in Patients With Diabetic Foot Syndrome
The purpose of this study is to determine whether the additional therapy with low dose urokinase is more effective than only a conventional standard therapy concerning ulcer-healing, rate of major amputation and survival.
- Conditions
- Diabetic Foot, Arterial Occlusive Disease, Ischemia
- Trial name
- NCT00823225
- Testing
- standard therapy, Urokinase
- Where
- 6 sites in Germany
- Volunteers
- 5 people
- Sponsor
- medac GmbH
Peripheral Arterial Occlusive Disease, Critical Limb Ischemia
Medium-term Results of Lower Limb Arterial Bypass
Peripheral arterial occlusive disease (PAOD) is a condition affecting the arteries of the lower limbs, caused by the progressive accumulation of lipid deposits that obstruct blood vessels.
- Conditions
- Peripheral Arterial Occlusive Disease, Critical Limb Ischemia, Arterial Revascularization, Arterial Bypass Surgery
- Trial name
- MERLLAB (NCT07093632)
- Testing
- Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb.
- Where
- France
- Volunteers
- 57 people
- Sponsor
- Hospices Civils de Lyon
Acute Ischemia of Lower Limb
The Indigo System in Acute Lower Limb Malperfusion
To evaluate, in a controlled setting, the early safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (San Francisco, California), and to define optimal technique for the use of these systems in patients…
- Trial name
- INDIAN (NCT03386370)
- Testing
- "Indigo" Mechanical Thrombectomy System
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Azienda Ospedaliera Universitaria Senese
Amputation, Lower Limb
Virtual Reality in the Rehabilitation in Patients With Lower Limb Amputation.
The goal of this clinical trial is to test the impact of virtual reality on rehabilitation for the patients after a major amputation.
- Conditions
- Amputation, Lower Limb, Rehabilitation, Activities of Daily Living
- Trial name
- NCT05773560
- Testing
- virtual reality rehabilitation
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- University Hospital Erlangen
Arteritis, Diabetes
Comparison of Two Lower Limb Bypass Types : Prosthesis Versus Autologous Vein
When medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass.
- Trial name
- REVA (NCT00221715)
- Testing
- femoropopliteal artery bypass
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Bordeaux
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
Atherosclerosis, Ischemia
Clinical Study of Stent Versus Direct Atherectomy to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
This is a randomized study comparing stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
- Trial name
- NCT02840786
- Testing
- plaque excision system, balloon and Stent
- Where
- China
- Volunteers
- 221 people
- Sponsor
- Xuanwu Hospital, Beijing
Peripheral Vascular Diseases
Effects of Remote Ischemic Preconditioning on Restenosis Post Lower Limb Revascularization Angioplasty
The investigators will established relation between restenosis and inflammatory response to shearing stress caused by angioplasty suggest that any mechanism that affect inflammatory response can consequently affect the restenosis…
- Trial name
- NCT02406131
- Testing
- Remote Ischemic Preconditioning
- Where
- 2 sites in Ireland
- Volunteers
- 40 people
- Sponsor
- National University of Ireland, Galway, Ireland
Сhronic Ischemia of the Lower Extremities, Atherosclerosis of the Tibial Arteries
Angioplasty of the Tibial Arteries Augmented Radio Frequency Denervation of the Popliteal Artery
Angioplasty augmented radiofrequency denervation popliteal artery, in our opinion, will remove the spasm with macro and microcirculatory blood flow, which increases revascularization patency of tibial arteries.
- Conditions
- Сhronic Ischemia of the Lower Extremities, Atherosclerosis of the Tibial Arteries, Lesion no More Than Two Tibial Arteries, Steno-occlusive Lesion of the Tibial Arteries
- Trial name
- ATRFPA (NCT02825446)
- Testing
- angioplasty tibial arteries, angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon"
- Where
- Russia
- Volunteers
- 15 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Ischemic Heart Disease
Can Changes in Velocity Time Integral Serve as a Sensitive Indicator for Monitoring Changes in Stroke Volume ?
Hypothesis: A validated technique to measure cardiac output (CO) using echocardiography is to calculate stroke volume from the product of LVOT area and LVOT VTI and multiplying the product with heart rate ( CO = SV x H/R; SV =…
- Trial name
- NCT02292888
- Testing
- Passive Leg Raising (PLR) test
- Volunteers
- 50 people
- Sponsor
- Fortis Hospital, India
Peripheral Artery Disease
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the…
- Trial name
- VOYAGER PAD (NCT02504216)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 532 sites in United States, Argentina and 32 more
- Volunteers
- 6,564 people
- Sponsor
- Bayer
Limb Ischemia, Diabetic Foot
Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia
Phase II national, multicenter, double-blind, randomized, placebo-controlled, phase-3 clinical trial of 3 parallel groups.
- Trial name
- NCT04466007
- Testing
- High dose allogeneic mesenchymal stromal cells, Low dose allogeneic mesenchymal stromal cells
- Where
- 10 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Chronic Limb-Threatening Ischemia
Agreement Study on AI-assisted Smartphone-based Monitoring Tool for Difficult-to-heal Ischemic Leg Ulcers
The purpose of the project is to investigate the agreement with Bland-Altman plots between an AI-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with…
- Trial name
- NCT06421961
- Where
- Sweden
- Volunteers
- 223 people
- Sponsor
- Sahlgrenska University Hospital
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, Peripheral Vascular Disease
Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
The purpose of this research study is to determine if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in the severely diseased…
- Trial name
- mesendo (NCT00518401)
- Testing
- Mesendo
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- TCA Cellular Therapy