Clinical trials: Atherosclerosis
Peripheral Arterial Disease
Audit and Screening Study to Determine the Prevalence of Peripheral Arterial Disease
The primary objective of the study is to establish the prevalence of lower extremity peripheral arterial disease (PAD), defined as an ankle-brachial index of less than or equal to 0.9, in subjects with at least two of the…
- Trial name
- ACHILLES (NCT00928629)
- Testing
- Ankle-brachial index (ABI) Screening Test
- Where
- 23 sites in Australia
- Volunteers
- 1,000 people
- Sponsor
- AstraZeneca
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
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.
Peripheral Artery Disease, Peripheral Vascular Disease
Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe
BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812). Data from BIOFLEX-I EU will be pooled with data in the IDE.
- Trial name
- BIOFLEX-I EU (NCT01661231)
- Testing
- Astron/Pulsar-18 stent
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 456 people
- Sponsor
- Biotronik AG
Atherosclerotic Cardiovascular Disease
A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease
This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that…
- Trial name
- NCT04992065
- Testing
- NNC0385-0434 A 15 mg, NNC0385-0434 A 40 mg, NNC0385-0434 A 100 mg
- Where
- 44 sites in United States, Belgium and 5 more
- Volunteers
- 267 people
- Sponsor
- Novo Nordisk A/S
Peripheral Arterial Disease
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
- Trial name
- EXCITE ISR (NCT01330628)
- Testing
- Turbo Elite Laser and Turbo Tandem Laser Guide Catheters, Balloon angioplasty
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 252 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease
SOLARIS Endoprosthesis in Iliac Occlusive Disease
Fifty patients will be treated with Solaris Endoprosthesis and followed up to 2 years with Walking Impairment Questionnaire and Doppler Ultrasound evaluation in 30 days, 6 months and 12 months.
- Trial name
- SOLARIS I (NCT03606629)
- Testing
- Endoprosthesis implantation
- Where
- Brazil
- Volunteers
- 5 people
- Sponsor
- Scitech Produtos Medicos SA
End Stage Kidney Disease
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo.
- Trial name
- POSIBIL6ESKD (NCT05485961)
- Testing
- CSL300
- Where
- 566 sites in United States, Argentina and 33 more
- Volunteers
- 3,110 people
- Sponsor
- CSL Behring
Atherosclerosis
Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity
Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical trials. It has shown significant improvement in lipid profile in patients with overweight or obesity
- Trial name
- V6 (NCT03042741)
- Testing
- atherosclerosis vaccine
- Where
- Mongolia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Immunitor LLC
Cardiovascular Risk
Precision Study of CLAiR AI Software
This multi-site precision study evaluated the performance and reproducibility of the CLAiR artificial intelligence (AI) software in identifying elevated risk of atherosclerotic cardiovascular disease (ASCVD) from retinal fundus…
- Trial name
- NCT07747233
- Testing
- CLAiR Artificial Intelligence Software
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Toku Eyes Ltd
Peripheral Arterial Disease, Vascular Diseases
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery
- Conditions
- Peripheral Arterial Disease, Vascular Diseases, Stenosis, Femoropopliteal Stenosis
- Trial name
- Efemoral I (NCT04584632)
- Testing
- Efemoral Vascular Scaffold System (EVSS)
- Where
- 8 sites in Australia, New Zealand
- Volunteers
- 100 people
- Sponsor
- Efemoral Medical, Inc.
Hypercholesterolemia, Atherosclerosis
Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)
To compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin 10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg daily in reducing the concentration of…
- Trial name
- NCT00651404
- Testing
- Ezetimibe
- Volunteers
- 137 people
- Sponsor
- Organon and Co
Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events
Impact of Alirocumab on Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events
To estimate ischemic event rates in individuals with established atherosclerotic cardiovascular disease (ASCVD) and no prior acute ischemic events, comparing alirocumab with no Proprotein Convertase Subtilisin/Kexin type 9…
- Trial name
- OPTIMUS-EPIC (NCT07734753)
- Testing
- Alirocumab, Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents)
- Where
- Netherlands
- Volunteers
- 4,006 people
- Sponsor
- Sanofi
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.
Atherosclerotic Cardiovascular Disease, Symptomatic Atherosclerosis
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated…
- Conditions
- Atherosclerotic Cardiovascular Disease, Symptomatic Atherosclerosis, Type2 Diabetes, Familial Hypercholesterolemia
- Trial name
- ORION-3 (NCT03060577)
- Testing
- Inclisiran, Evolocumab
- Where
- 52 sites in United States, Canada and 3 more
- Volunteers
- 382 people
- Sponsor
- Novartis Pharmaceuticals
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.
Cerebral Ischemia, Cerebral Atherosclerosis
DEB for Symptomatic Intracranial Atherosclerosis Stenosis
A prospective, multi-center, single-arm study to evaluate the safety and efficacy of drug eluting balloon catheter for the treatment of patients with symptomatic intracranial atherosclerotic stenosis.
- Trial name
- NCT04821726
- Testing
- Drug eluting balloon (Vmoky)
- Where
- China
- Volunteers
- 155 people
- Sponsor
- Yinyi(Liaoning) Biotech Co., Ltd.
Coronary Artery Disease, Peripheral Arterial Disease
Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.
- Trial name
- NCT05747287
- Testing
- microcatheter
- Where
- 3 sites in China
- Volunteers
- 60 people
- Sponsor
- BrosMed Medical Co., Ltd
Peripheral Artery Disease, Atherosclerosis
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
This study aims to conduct a randomized, double blind, randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial and popliteal…
- Conditions
- Peripheral Artery Disease, Atherosclerosis, Arterial Disease
- Trial name
- FUTURE-SFA (NCT04511234)
- Testing
- MagicTouch PTA sirolimus drug coated balloon (DCB), POBA standard balloon
- Where
- 20 sites in Singapore, Taiwan and 1 more
- Volunteers
- 279 people
- Sponsor
- Concept Medical Inc.