Clinical trials: Chronic Limb Ischemia
Critical Limb Ischemia (CLI)
Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System
This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal clinical study in which subjects are evaluated for prevention of major limb amputation in the treatment of non-reconstructable…
- Trial name
- CLIRST III (NCT02538978)
- Testing
- Autologous Bone Marrow Concentrate (aBMC)
- Volunteers
- 224 people
- Sponsor
- Cesca Therapeutics, Inc.
Critical Limb Ischemia (CLI)
IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
A prospective, multi-center, randomized trial to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or…
- Trial name
- GENIUS (NCT04849325)
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™), Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 29 sites in China
- Volunteers
- 120 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Critical Limb Ischemia
UT-15C SR in the Treatment of Critical Limb Ischemia
This study will evaluate UT-15C sustained release tablets in subjects experiencing ischemic lower limb rest pain related to advanced peripheral arterial disease.
- Trial name
- NCT00445159
- Testing
- UT-15C SR (treprostinil diethanolamine) 1mg oral tablets
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Southern Arizona Vascular Institute
CLTI Defined as Rutherford Category 4 or 5
Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization
Chronic limb threatening ischemia (CLTI) is defined as ischemic foot pain at rest or non-healing foot wounds that is attributable to severe peripheral arterial disease (PAD).Revascularization is the cornerstone of therapy to…
- Trial name
- DAPTCLTI (NCT07512960)
- Testing
- Clopidogrel 75 mg/day
- Where
- France
- Volunteers
- 614 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Chronic Limb Ischemia
Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Percutaneous Transluminal Angioplasty Revascularization
This is a prospective, multi-center, randomized pilot study to document the effects of adventitial delivery of dexamethasone after balloon angioplasty of lesions below the knee in symptomatic patients with critical limb ischemia…
- Trial name
- LIMBO-PTA (NCT02479555)
- Testing
- Dexamethasone sodium phosphate injection, USP, 4 mg/mL
- Where
- 3 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Mercator MedSystems, Inc.
Chronic Limb-Threatening Ischemia
Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural…
- Trial name
- CALCIO (NCT06149650)
- Testing
- Shockwave Medical IVL System
- Where
- 39 sites in Austria, Canada and 6 more
- Volunteers
- 400 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Peripheral Artery Disease, Critical Limb Ischemia
Platelet Reactivity in PAD Undergoing Percutaneous Angioplasty
Dual antiplatelet therapy has a key role in a prevention of thrombosis of treated artery in patients undergoing percutaneous transluminal angioplasty (PTA).
- Conditions
- Peripheral Artery Disease, Critical Limb Ischemia, Claudication, Intermittent
- Trial name
- PAD (NCT04165629)
- Testing
- Aspirin 300mg and Clopidogrel 300mg
- Where
- Serbia
- Volunteers
- 450 people
- Sponsor
- Clinical Centre of Serbia
Critical Limb Ischemia
Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA)
The investigators designed a randomized clinical trial (stem cell emergency life threatening arteriopathy or SCELTA) to compare the therapeutic efficacy of the auto-transplant of enriched circulating EPCs (ECEPCs) with…
- Trial name
- SCELTA (NCT02454231)
- Testing
- Transplantation of circulating CD14+CD34+cells, Transplantation of BM MNC
- Where
- Italy
- Volunteers
- 45 people
- Sponsor
- University of Florence
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
Peripheral Vascular Disease, Intermittent Claudication
DURABILITY-200: EverFlex 200mm Long Nitinol Stents in TASC C&D Femoropopliteal Lesions
The objective of this clinical investigation is to evaluate the long-term (up to 12 months) outcome of the 200 mm long self-expanding nitinol EverFlex (ev3) stent in long femoropopliteal lesions (TASC C \& D) Is is the first time…
- Conditions
- Peripheral Vascular Disease, Intermittent Claudication, Critical Limb Ischemia
- Trial name
- NCT00637741
- Testing
- Everflex 200
- Where
- 2 sites in Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Flanders Medical Research Program
Critical Limb Ischemia, Peripheral Arterial Disease
IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA
To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the…
- Trial name
- NCT02963649
- Testing
- DCB, PTA
- Where
- 9 sites in Belgium, France and 3 more
- Volunteers
- 50 people
- Sponsor
- Medtronic Endovascular
Critical Ischemia of Foot
Pedal Arch Revascularization in Patients With Chronic Limb Threatening Ischemia
Chronic limb threatening ischemia (CLTI) is a major cause of morbidity and mortality worldwide and is characterized by multilevel disease, often involving the tibiopedal vessels .
- Trial name
- NCT05098548
- Testing
- angioplasty
- Volunteers
- 35 people
- Sponsor
- Assiut University
Chronic Limb Threatening Ischemia
Multimodal Noninvasive Assessment of Peripheral Circulation in Chronic Limb-threatening Ischemia
Assessment of a novel diagnostic method for screening and diagnosing chronic limb-threatening ischemia (CLTI). Using hyperspectral and thermal imaging, the perfusion and oxygenation in the lower limbs will be studied in healthy…
- Trial name
- NCT05786001
- Where
- Finland
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Tampere University
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
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 4.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03111238
- Testing
- REX-001
- Where
- 15 sites in Czechia, Germany and 4 more
- Volunteers
- 3 people
- Sponsor
- Ixaka Ltd
Chronic Limb Ischemia
Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee (TANGO)
This is a prospective, multi-center, randomized, dose escalation study to document the effects of adventitial delivery of temsirolimus (Torisel) after revascularization of lesions below the knee in symptomatic patients with…
- Trial name
- TANGO (NCT02908035)
- Testing
- Temsirolimus, Saline
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Mercator MedSystems, Inc.
Critical Limb Ischemia
Autologous Endothelial Progenitor Cells (EPCs) From Peripheral Blood in the Treatment of Critical Limb Ischemia
Aim: to value the safety and efficacy of local intramuscular administration of immunoselected autologous endothelial progenitor cells in the treatment of critical limb ischemia in patients without revascularization options.
- Trial name
- NCT01595776
- Testing
- Endothelial progenitor cells intramuscular implant
- Where
- Italy
- Volunteers
- 8 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Peripheral Vascular Diseases
Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia
This is a 15 patient clinical trial assessing the safety and feasibility of using Endometrial Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are not eligible for surgical or catheter-based…
- Trial name
- NCT01558908
- Testing
- Administration of ERC
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Medistem Inc.
Critical Limb Ischemia
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia.
- Trial name
- NCT01064440
- Testing
- Low Dose VM202, High Dose VM202
- Where
- 16 sites in United States, South Korea
- Volunteers
- 52 people
- Sponsor
- Helixmith Co., Ltd.
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)
Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic stem/progenitor cells (HSPC) (BGC101), in the…
- Conditions
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- EnEPC-CLI (NCT02805023)
- Testing
- BGC101 (autologous EnEPC preparation), Control medium
- Where
- 5 sites in United States, Israel
- Volunteers
- 40 people
- Sponsor
- BioGenCell Ltd.