Clinical trials: Atherosclerosis of Extremities
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
Peripheral Artery Disease, Coronary Artery Disease
Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization
Peripheral artery disease, lack or blood flow to the legs, has a high prevalence in the Veteran population. In patients with severe peripheral artery disease that requires an endovascular or surgical intervention for lower leg…
- Trial name
- CAD in sPAD (NCT06387355)
- Testing
- Coronary computed topography (CT) angiography with FFR-CT
- Where
- 7 sites in United States
- Sponsor
- VA Office of Research and Development
Peripheral Arterial Disease
A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery
Vascular calcification is prevalent in patients with Peripheral artery disease (PAD), especially those with combined diabetes or chronic kidney disease.
- Trial name
- STRIKE (NCT06636968)
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Zhongshan Hospital
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
Arterial Occlusive Disease, Peripheral Vascular Disease
Study of Hepatocyte Growth Factor (HGF) Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia Patients With Peripheral Ischemic Ulcers
The objective of this study is to test the hypothesis that AMG0001 treatment is safe and induces angiogenesis as detected by improved wound healing, reduction in amputation, improved pain at rest and hemodynamic measurement and…
- Conditions
- Arterial Occlusive Disease, Peripheral Vascular Disease, Ischemia, Ulcers
- Trial name
- NCT00189540
- Testing
- HGF plasmid
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- AnGes USA, Inc.
Critical Limb Ischemia
Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure
In chronic CLI patients who are appropriate candidates for endovascular procedures - and many patients are not because of their advanced age and disease state - the treatment regimen may include endovascular procedures such as…
- Trial name
- NCT00651885
- Testing
- treprostinil dienthanolmine sustained release
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Ochsner Health System
Leg Pain, Ulcer
Stem Cell Study for Patients With Leg Ulcer/Gangrene
The purpose of this study is to determine if stem cell therapy with one's own cells (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve…
- Conditions
- Leg Pain, Ulcer, Gangrene, Ischemia
- Trial name
- NCT00221143
- Testing
- Autologous peripheral blood CD34 positive cell therapy
- Where
- 2 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Peripheral Collaterals, Arteriogenesis
Assessment of Natural Bypasses in the Lower Limb
Concerning the promotion of peripheral collateral growth, clinical studies investigating new therapeutic strategies have used imprecise assessment methods and therefore determined only "weak" endpoints.
- Conditions
- Peripheral Collaterals, Arteriogenesis, Coronary Artery Disease
- Trial name
- NCT01742455
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Ischemia, Peripheral Arterial Disease
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)
- Conditions
- Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases
- Trial name
- NCT02044666
- Testing
- Micronized Small Intestinal Submucosa (SIS)
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Cook Group Incorporated
Critical Limb Ischemia
Serrantor OCT Study
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
- Trial name
- NCT06434194
- Testing
- Serranator PTA Serration Catheter, PTA (Standard of Care)
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cagent Vascular LLC
Peripheral Arterial Disease, Subarachnoid Block
Effect of Subarachnoid Block and Femoropopliteal Block to Limb Perfusion in PAD Patients
This pilot study investigates the effects of femoropopliteal and subarachnoid nerve blocks on tissue oxygen saturation (StO2) in patients with Peripheral Arterial Disease (PAD) during lower limb surgeries.
- Conditions
- Peripheral Arterial Disease, Subarachnoid Block, Femoropopliteal Block, Tissue Oxygen Saturation
- Trial name
- NCT06702202
- Testing
- Mixture of local anesthetics, 0.5% hyperbaric bupivacaine
- Where
- Indonesia
- Volunteers
- 16 people
- Sponsor
- Universitas Indonesia
Peripheral Artery Disease
The Future of Revascularization Using a Bioprotec Graft
The main purpose of this study is the rate assessment of rescued limbs, one year after a BIOPROTEC vascular graft.
- Trial name
- REVATEC (NCT04018846)
- Testing
- Revascularization using a BIOPROTEC Graft
- Where
- France
- Volunteers
- 46 people
- Sponsor
- Hôpital NOVO
Peripheral Artery Disease, Peripheral Vascular Disease
Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)
The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00951210
- Testing
- PLX-PAD
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Pluristem Ltd.
Intermittent Claudication, Critical Limb Ischemia
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)
This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.
- Trial name
- NCT00300690
- Testing
- 6 mm Uni-graft® (B-Braun), 6 mm Gore-Tex® (WL Gore)
- Volunteers
- 400 people
- Sponsor
- University Hospital, Gentofte, Copenhagen
Peripheral Arterial Disease
Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation
To demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff…
- Trial name
- COMPAR-MI (NCT04709991)
- Testing
- Endovascular procedure
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Therenva
Critical Limb Ischemia
Alprostadil as an Adjuvant Therapy With Indirect Angiosomal Revascularization in Critical Limb Ischemia.
The aim of this study is to assess the efficacy of Alprostadil (Prostaglandin E2) as adjuvant therapy after failure of direct but indirect angiosomal revascularization in patients with critical limb ischemia.
- Trial name
- NCT04312555
- Testing
- Alprostadil
- Volunteers
- 30 people
- Sponsor
- Assiut University
Critical Limb Ischemia, Peripheral Arterial Disease
Pilot Safety Study of Injectable SIS for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLIC (NCT02145845)
- Testing
- Injectable SIS
- Where
- Czechia
- Volunteers
- 13 people
- Sponsor
- Cook Group Incorporated
Peripheral Artery Disease, Diabetes Mellitus
The Application of Digital Infrared Thermal Imaging in Peripheral Artery Disease of the Lower Extremities
Peripheral artery disease (PAD) is highly prevalent. It occurs most often in the lower extremities. Symptoms include intermittent claudication, ischemic pain, ulceration and necrosis. Amputation may be necessary in severe cases.
- Trial name
- NCT02783677
- Testing
- Percutaneous balloon angioplasty
- Where
- Taiwan
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
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
Peripheral Arterial Disease, Angioplasty
Ultrasound to Enhance Paclitaxel Uptake in Critical Limb Ischemia: the PACUS Trial
The PACUS Trial was a single center, single blinded, randomized trial designed to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy to improve local Paclitaxel delivery effects in…
- Trial name
- PACUS (NCT02625740)
- Testing
- Local exposition of target lesion to high intensity, low-frequency ultrasound, drug eluting ballon angioplasty, Flow occlusion with an angioplasty balloon
- Volunteers
- 56 people
- Sponsor
- University of Rome Tor Vergata