Clinical trials: Ischemia Limb
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
Peripheral Arterial Disease, Peripheral Artery Disease
Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction
Digital Variance Angiography (DVA) is a new tool in medical imaging with proven image quality reserve. The previously observed quality reserve of Digital Variance Angiography (DVA) in lower extremity angiographies, allowed to…
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Femoral Artery Stenosis, Femoral Artery Occlusion
- Trial name
- NCT04343196
- Testing
- Diagnostic Angiography (DSA or DVA based on randomization result)
- Where
- Hungary
- Volunteers
- 114 people
- Sponsor
- Kinepict Health Ltd.
Diabetic Foot, Peripheral Arterial Disease
TEsting for Arterial Disease in Diabetes (TrEAD) Study
This study will focus on determining; How accurate the test is in detecting poor circulation How it's accuracy compares to other commonly used tests, and Whether test results are linked to the chance of ulcer healing or…
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases
- Trial name
- NCT04058626
- Testing
- Transcutaneous pressure of oxygen (TcPO2), Toe Brachial Pressure Index (TBPI), Podiatry Ankle Duplex scan (PAD-scan)
- Where
- 2 sites in United Kingdom
- Volunteers
- 305 people
- Sponsor
- Imperial College Healthcare NHS Trust
Critical Limb Ischemia
Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease
Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study in treating 18 recipients with ischemic limb…
- Trial name
- NCT02336646
- Testing
- Allogenic MSC, Normal saline
- Where
- Taiwan
- Volunteers
- 18 people
- Sponsor
- Taiwan Bio Therapeutics Inc.
Critical Limb Ischemia, Peripheral Arterial Disease
Evaluation of Post-Angioplasty Outcomes
There is no hard and fast rule guiding the clinical decision between angioplasty and amputation. As such, this decision is greatly dependant on each clinician's experience and preference as to whether treatment should be…
- Trial name
- NCT05018949
- Testing
- Lower limb angioplasty
- Where
- Singapore
- Volunteers
- 1,000 people
- Sponsor
- Singapore General 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
Lower Limb Ischemia
Feasibility Study of the TGI Adipose-derived Stromal Cell (ASC)-Coated ePTFE Vascular Graft
Researchers are actively seeking a way to coat the inside of a synthetic graft so that it more closely resembles native vessels and therefore has low thrombogenicity and low incidence of stenosis.
- Trial name
- TGI-PVG-IDE (NCT01305863)
- Testing
- ASC coated ePTFE vascular graft, Propaten graft
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Tissue Genesis
Critical Limb Ischemia
Evaluation of the Tissue Genesis® Icellator Cell Isolation System™ to Treat Critical Limb Ischemia
The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis® Icellator Cell Isolation System™ in Critical Limb Ischemia.
- Trial name
- CLI-DI (NCT02234778)
- Testing
- TGI SVF material via intramuscular injection
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Tissue Genesis
Peripheral Arterial Disease, Arterial Occlusive Diseases
Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery
The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
- Conditions
- Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, Arteriosclerosis
- Trial name
- PAVENST (NCT02212470)
- Testing
- Drug Eluting Balloon Angioplasty, Nitinol stenting
- Where
- Brazil
- Volunteers
- 85 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
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, Peripheral Arterial Disease
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- MOBILE (NCT01049919)
- Testing
- Bone marrow concentration device
- Where
- 25 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Critical Limb Ischemia
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI).
- Trial name
- REVIVE (NCT01483898)
- Testing
- Ixmyelocel-T
- Where
- 86 sites in United States
- Volunteers
- 41 people
- Sponsor
- Vericel Corporation
Cardiogenic Shock, Cardiac Arrest
Lower Limb Surveillance During VA-ECLS
Temporary cardiac support by VA-ECLS can lead to lower limb ischemia. The aim of this study is to evaluate a multi-modal strategy (physical examination, NIRS monitoring and angiography through the reperfusion canula) of lower…
- Conditions
- Cardiogenic Shock, Cardiac Arrest, Lower Limb Ischemia
- Trial name
- NCT03910062
- Testing
- Lower limb angiography via the reperfusion cannula and NIRS monitoring
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Central Hospital, Nancy, France
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
Critical Limb Ischemia
Continuous Sciatic Block Nerve in the Management of Vascular Pain in Critical Ischemia of Lower Limbs Patients
Critical limb ischemia (CLI) is associated with severe pain that is a therapeutic challenge whit therapeutic limits for the use of conventional analgesics medications.
- Trial name
- NCT04278014
- Testing
- ultrasound-guided continuous sciatic block with longitudinal approach
- Where
- 2 sites in Colombia
- Volunteers
- 13 people
- Sponsor
- Universidad de Antioquia
Critical Limb Ischemia
Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients.
This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared to the standard treatment (clopidogrel plus aspirin) in patients with critical limb ischemia undergoing infrapopliteal arterial…
- Trial name
- AGRIPPA (NCT04229264)
- Testing
- Apixaban, ASA, Clopidogrel 75mg
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Science Valley Research Institute
Critical Limb Ischemia
Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical Limb Ischemia (N-O CLI)
The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will be treated by the administration…
- Trial name
- NCT03423732
- Testing
- CardioCell
- Where
- 2 sites in Poland
- Volunteers
- 50 people
- Sponsor
- John Paul II Hospital, Krakow
Critical Limb Ischemia, Peripheral Artery Disease
Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair
The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the…
- Trial name
- NCT02044003
- Testing
- Innovasc Tack Intravascular Staple System (Tack)
- Where
- 2 sites in Paraguay
- Volunteers
- 11 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Critical Limb Ischemia, Peripheral Artery Disease
Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study
Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from 1.5mm to 4.5mm.
- Trial name
- TOBABTK (NCT02235675)
- Testing
- Tack-It Endovascular System
- Where
- Austria
- Volunteers
- 35 people
- Sponsor
- Philips Clinical & Medical Affairs Global
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