Clinical trials: Critical Limb Ischaemia
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
Chronic Limb-Threatening Ischemia
Colchicine in Chronic Limb-Threatening Ischemia
Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease, a condition in which narrowed or blocked arteries reduce blood flow to the legs.
- Trial name
- CIRCLE-Asia (NCT07536373)
- Testing
- Colchicine 0.5 MG Oral Tablet Once Daily
- Where
- 5 sites in Taiwan
- Volunteers
- 200 people
- Sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
Critical Limb Ischemia
Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.
The spectrum of lower extremity peripheral arterial disease (PAD) ranges from exhibiting no symptoms to limb threatening gangrene.
- Trial name
- NCT04974905
- Testing
- retrograde access for re-canalization of infra-inguinal arterial occlusive disease
- Volunteers
- 40 people
- Sponsor
- Sohag University
Peripheral Arterial Disease
A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD
The objective of the clinical trial is to gather evidence on the safety, performance and clinical efficacy Vibrato Sleeve TUS in people with peripheral artery disease (PAD).
- Trial name
- Concerto (NCT05100745)
- Testing
- Therapeutic Device
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Vibrato Medical, Inc.
Critical Limb Ischemia, Extracellular Matrix Alteration
Matrix Metalloproteinases in Patients With Critical Limb Ischemia Undergoing Surgical Revascularization
In the present study the investigators will evaluate MMPs. serum levels variations in patients affected by critical limb ischemia, before and after lower limb surgical revascularization through venous or prosthetic bypass.
- Conditions
- Critical Limb Ischemia, Extracellular Matrix Alteration, Peripheral Revascularisation
- Trial name
- ROMAMETA (NCT02388867)
- Testing
- Polytetrafluoroethylene (PTFE) bypass grafting., Autogenous vein bypass grafting
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Catanzaro
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
Critical Limb Ischemia
Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia
The purpose of this study is to evaluate the safety and efficacy of the concentrated autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia patients.
- Trial name
- NCT01472289
- Testing
- Autologous Bone Marrow Mononuclear cells (BMMNCs)
- Where
- India
- Volunteers
- 17 people
- Sponsor
- TotipotentSC Scientific Product Pvt. Ltd.
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
Aging, Walking, Difficulty
Chronic Wounds and Blood Circulation Detection
Lower limb circulatory insufficiency and the associated chronic wounds are common health problems among the elderly. These issues not only affect the individual's mobility and quality of life but also potentially increase medical…
- Conditions
- Aging, Walking, Difficulty, Chronic Limb-Threatening Ischemia, Chronic Disease
- Trial name
- NCT07330635
- Testing
- Intervention 1: Mixed exercise program, Intervention 2: High-intensity rowing exercise, Intervention 3: Vibration exercise
- Where
- Taiwan
- Volunteers
- 425 people, healthy volunteers welcome
- Sponsor
- National Health Research Institutes, Taiwan
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, Peripheral Arterial Disease
Chelation Therapy in Diabetic Patients With Critical Limb Ischemia
This is a Pilot Trial Using Chelation Therapy for Limb Preservation in Diabetic Patients with Critical Limb Ischemia.
- Trial name
- TACT-PAD (NCT03424746)
- Testing
- disodium EDTA
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Mt. Sinai Medical Center, Miami
Critical Limb Ischemia, Peripheral Arterial Disease
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial 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 peripheral…
- Trial name
- NCT05854641
- Testing
- Stempeucel®
- Where
- Malaysia
- Volunteers
- 10 people
- Sponsor
- Cell Biopeutics Resources Sdn Bhd
Sarcopenia, Peripheral Arterial Disease
Sarcopenia and Peripheral Artery Disease With Chronic Limb Threatening Ischemia
To evaluate the correlation of Sarcopenia Parameters and Peripheral Artery Disease with chronic limb threatening ischaemia.
- Conditions
- Sarcopenia, Peripheral Arterial Disease, Chronic Limb Threatening Ischemia
- Trial name
- SAC (NCT07037979)
- Testing
- Not applicable- observational study
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Fudan University
Critical Limb Ischemia, Ischemic Ulcers
Stem Cells for Treating Critical Ischemia
Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots
- Trial name
- NCT00488020
- Testing
- stem cells transplant
- Where
- Brazil
- Volunteers
- 10 people
- Sponsor
- Instituto de Molestias Cardiovasculares
Peripheral Vascular Disease, Peripheral Arterial Disease
Muscle Perfusion in Patients With PAD by Non-invasive MSOT
The aim of the proposed study is to define an independent parameter for the diagnostic assessment of the perfusion situation of the calf muscle based on Multispectral Optoacoustic Tomography (MSOT) in a cross-sectional collective…
- Trial name
- NCT04641091
- Testing
- Multispectral Optoacustic Tomography (MSOT)
- Where
- Germany
- Volunteers
- 220 people
- Sponsor
- University Hospital Erlangen
Critical Limb Ischemia, Drug Effect
Comparison of Sirolimus vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia
The objective of this study is to compare the remote patency of paclitaxel versus sirolimus eluting balloons in patients with CLI undergoing tibial artery revascularization.
- Trial name
- DebateBTKDuell (NCT04594889)
- Testing
- angioplasty
- Where
- Italy
- Volunteers
- 170 people
- Sponsor
- Ospedale San Donato
Critical Limb Ischemia
Exercise In Critical Limb Ischaemia Patients Having Surgery Proof of Concept
Patients with critical limb ischaemia (CLI) are at risk of losing their limb and/or life and therefore have no option but to undergo bypass or amputation surgery.
- Trial name
- EXERCISE (NCT04043078)
- Testing
- Exercise
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Hull University Teaching Hospitals NHS Trust
Critical Limb-Threatening Ischemia, Critical Limb Ischemia
Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia
The objective of this prospective, multi-center, clinical investigation is to evaluate the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions.
- Conditions
- Critical Limb-Threatening Ischemia, Critical Limb Ischemia, Critical Lower Limb Ischemia
- Trial name
- MAGNITUDE-BTK (NCT06075940)
- Testing
- MAGNITUDE BRS
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- R3 Vascular Inc.
Critical Limb Ischemia, Infrapopliteal Lesions
Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions.
This study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.
- Trial name
- NCT04365075
- Testing
- Excimer Laser Combined with DCB, Angioplasty Alone
- Where
- China
- Volunteers
- 184 people
- Sponsor
- Xuanwu Hospital, Beijing
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