Clinical trials: Critical Ischemia Limb
Peripheral Arterial Disease
Ultrasound Cavitation Therapy for CLI
In this study, we will explore how ultrasound exposure of ultrasound contrast agents, which produces beneficial shear-mediated bioeffects, can be used to treat patients with severe non-healing ulcers secondary to peripheral…
- Trial name
- NCT05749250
- Testing
- Acoustic cavitation of ultrasound enhancing agents
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Virginia
Peripheral Arterial Disease
The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve will improve systemic inflammation and patency of peripheral vascular intervention (PVI).
- Trial name
- OMEGA-PVI (NCT02096757)
- Testing
- Pro-Omega
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of California, San Francisco
Peripheral Arterial Occlusive Disease, Critical Limb Ischemia
Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD/CLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)
The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of [89Zr]Zr-DFO-APAC in patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and healthy volunteers.
- Trial name
- CHASE (NCT06204237)
- Testing
- [89Zr]Zr-DFO-APAC, PET/CT scan
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Aplagon Oy
Peripheral Arterial Disease, Critical Limb-Threatening Ischaemia
Shockwave ®S4 Catheter IVL to Treat Infrapopliteal Calcified Stenoses and/or Occlusions in CLTI Patients (LEGACY)
The study will evaluate the safety and efficacy of Peripheral Intravascular Lithotripsy system with Shockwave S4 catheter® for the treatment of de novo, re-stenosis or re-occlusive,calcified chronic total occlusion (CTOs) lesions…
- Trial name
- LEGACY (NCT05755412)
- Where
- 6 sites in Italy
- Volunteers
- 9 people
- Sponsor
- EndoCore Lab s.r.l.
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.
Microbial Colonization, Coronary Artery Disease
Effect of Acute Cardiovascular Disease on Microbiome
Atherosclerotic diseases such as coronary artery disease (CAD) and peripheral arterial disease (PAD) are the leading cause of morbidity and mortality in the industrialized world.
- Conditions
- Microbial Colonization, Coronary Artery Disease, Myocardial Infarction, Acute Coronary Syndrome
- Trial name
- MIAMI (NCT05456802)
- Testing
- Standard of care treatment
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University Hospital, Essen
Critical Lower Limb Ischemia, Abdominal Aortic Aneurysms
The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures
Prospective randomized comparison between endovascular procedures performed with iodinated contrast or carbon dioxide as intraarterial contrast.
- Trial name
- NCT01861327
- Testing
- CO2, Iodine contrast media
- Where
- Brazil
- Volunteers
- 120 people
- Sponsor
- Nelson Wolosker
Chronic Limb-Threatening Ischemia
Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment
Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment
- Trial name
- Tevi-LuSy (NCT06111599)
- Testing
- lumbar sympathetic blockade
- Where
- Slovakia
- Volunteers
- 60 people
- Sponsor
- EPC Education s.r.o.
Peripheral Arterial Disease, Critical Limb Ischemia
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)
This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).
- Trial name
- DEEPER REVEAL (NCT05358353)
- Testing
- Bare Temporary Spur Stent System
- Where
- 48 sites in United States
- Volunteers
- 130 people
- Sponsor
- ReFlow Medical, Inc.
PAOD - Peripheral Arterial Occlusive Disease, PAD
Recombinant SeV-hFGF2/dF Injection for PAOD
Lower extremity arteriosclerosis obliterans is due to the formation of atherosclerotic plaque in the lower extremities, resulting in the stenosis and occlusion of the artery, leading to chronic ischemia of the limbs.
- Conditions
- PAOD - Peripheral Arterial Occlusive Disease, PAD, Critical Limb Ischemia
- Trial name
- NCT03668353
- Testing
- Recombinant SeV-hFGF2/dF Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Critical Limb Ischemia
Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.
To evaluate the safety and effectiveness of the Spur System in a patient population with infrapopliteal artery disease (tibioperoneal, anterior/posterior tibial and peritoneal arteries) when used in conjunction with…
- Trial name
- DEEPER (NCT03669458)
- Testing
- Below the Knee peripheral intervention
- Where
- Dominican Republic
- Volunteers
- 21 people
- Sponsor
- ReFlow Medical, Inc.
Critical Limb Ischemia
Registry of First-line Treatments in Patients With Critical Limb Ischemia
The principal research question is which treatment modality between open surgical, endovascular and conservative therapy is the most effective in terms of limb salvage, survival and reinterventions in patients with critical limb…
- Trial name
- CRITISCH (NCT01877252)
- Testing
- Surgical revascularization, Endovascular revascularization, No vascular intervention
- Where
- Germany
- Volunteers
- 1,200 people
- Sponsor
- St. Franziskus Hospital
Critical Lower Limb Ischemia
Allografts in Surgery of the Main Arteries
The study will examine the results of the use of biological materials (allogeneic arterial grafts, allogeneic venous graft, autologous vein, biological bovine decellularized graft) as a bypass grafts for reconstructive…
- Trial name
- NCT05455138
- Testing
- Arterial bypass grafting
- Where
- Russia
- Volunteers
- 200 people
- Sponsor
- Ryazan State Medical University
Peripheral Artery Disease, Vascular Disease
Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)
Patients scheduled for major extremity lower amputation to receive bone marrow cells (cBMA) injected IM in the leg proximal to the amputation in the index limb to prevent ischemic wound complications after surgery.
- Conditions
- Peripheral Artery Disease, Vascular Disease, Critical Limb Ischemia
- Trial name
- MarrowCHAMP (NCT02863926)
- Testing
- Injection of cBMA aspirate into the index leg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Michael Murphy
Peripheral Arterial Disease
Belgian-Italian Trial to Evaluate the Efficacy and Safety of Below The Knee (BTK) Treatment With the Luminor 14 Paclitaxel Coated Percutaneous Transluminal Angioplasty Balloon Catheter of iVascular
The BIBLIOS trial investigates the efficacy and safety of BTK treatment of patients suffering from critical limb ischemia (Rutherford 5) with the Luminor-14 Paclitaxel coated Percutaneous Transluminal Angioplasty Balloon catheter…
- Trial name
- BIBLIOS (NCT03845543)
- Testing
- Luminor-14 Paclitaxel eluting balloon
- Where
- 9 sites in Belgium, Italy and 1 more
- Volunteers
- 150 people
- Sponsor
- ID3 Medical
Critical Limb Ischemia
MOTIV BTK Randomized Controlled Trial
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
- Trial name
- NCT05406622
- Testing
- MOTIV Sirolimus-Eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 26 sites in United States, Germany
- Volunteers
- 292 people
- Sponsor
- REVA Medical, Inc.
Chronic Limb-Threatening Ischemia
Validating GLASS Score in Predicting Acute Limb Events in CLTI Patients
Ischemia is a severe medical condition that occurs when the blood and oxygen supply to a specific part of the body is significantly reduced or completely absent, it can affect any body part, often the legs.
- Trial name
- PROMOTEGLASS (NCT06186544)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Cardiff and Vale University Health Board
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
Critical Limb Ischemia
BEST vCLI Registry
For subjects with critical limb ischemia, identify patient, physician/hospital, and geographic factors associated with variations in treatment strategies; compare treatments and outcomes, including quality of life, cost and cost…
- Trial name
- BEST (NCT04191746)
- Where
- United States
- Volunteers
- 1,009 people
- Sponsor
- Duke University
Peripheral Arterial Disease
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter…
- Trial name
- TOBA II BTK (NCT02942966)
- Testing
- Tack Endovascular System
- Where
- 49 sites in United States, Austria and 4 more
- Volunteers
- 233 people
- Sponsor
- Philips Clinical & Medical Affairs Global