Clinical trials: Atherosclerosis
Peripheral Artery Disease
Soundbite Crossing System Peripheral First in Man
This is a clinical study aimed at demonstrating the safety and product performance of the SoundBite Crossing System. The study shall demonstrate that the SoundBite Crossing System can facilitate passage of a standard guidewire…
- Trial name
- NCT03013088
- Testing
- CTO Crossing
- Where
- 2 sites in Canada
- Volunteers
- 37 people
- Sponsor
- SoundBite Medical Solutions, Inc.
Diabetic Peripheral Neuropathy
Exploratory Study of the Efficacy of Standard of Care Revascularization of the Lower Extremity
The purpose of this study is to evaluate the efficacy of the standard of care revascularization of the lower extremity with the addition of revascularization of the lateral plantar artery and anterior pedal loop of the foot as…
- Trial name
- NCT04720170
- Testing
- Revascularization
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Diabetes and Glandular Disease Clinic
Cardiovascular Diseases, Heart Diseases
Niacin Plus Statin to Prevent Vascular Events
The purpose of this study is to determine whether raising "good cholesterol" with a drug based on the vitamin niacin, while lowering "bad cholesterol" with a statin drug, can prevent more heart disease than the statin alone.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Coronary Disease
- Trial name
- NCT00120289
- Testing
- Extended release niacin, Simvastatin
- Where
- 91 sites in United States, Canada
- Volunteers
- 3,414 people
- Sponsor
- Axio Research. LLC
Peripheral Arterial Disease
Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease
This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.
- Trial name
- DALIA (NCT01026389)
- Testing
- Dotarem, Gadovist
- Where
- Austria
- Volunteers
- 189 people
- Sponsor
- Guerbet
Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease
A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab
This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.
- Conditions
- Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Familial
- Trial name
- VICTORION-LEAP (NCT07543731)
- Where
- Switzerland
- Volunteers
- 5,995 people
- Sponsor
- Novartis Pharmaceuticals
Coronary Artery Disease
Multicentre Registry of CCTA, IVUS and OCT
The Invictus Registry will compare the diagnostic performance of coronary computed tomography angiography (CCTA) versus intravascular imaging by intravenous ultrasound (IVUS) or optical coherence tomography (OCT) for the…
- Trial name
- NCT04066062
- Where
- 9 sites in Japan
- Volunteers
- 1,700 people
- Sponsor
- Cleerly, Inc.
Atherosclerosis
A Healthy Volunteer Pharmacokinetic Study of Single and Repeat Doses of SB-480848
This study is designed to assess the pharmacokinetics of darapladib and its metabolites following single and 28 days of repeat dosing of darapladib.
- Trial name
- NCT00743860
- Testing
- darapladib
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.
- Conditions
- Coronary Artery Disease, Atherosclerosis of Coronary Artery, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOMAG-LL (NCT07091682)
- Testing
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Where
- 14 sites in Germany, Hungary and 5 more
- Volunteers
- 100 people
- Sponsor
- Biotronik AG
Dyslipaemia, Atherosclerosis Risk
Dyslipaemia, Atherosclerosis Risk and Increased hsCRP and Inflammatory and Oxidative Status in the Spanish Population. Database Analysis of Previous Studies Performed in Spain
The present project is aimed at determining the prevalence of LDL-C <130 mg/dl with hsCRP ≥2mg/l, and of HDL-C < 40 mg/dl in Spain together with the estimation of cardiovascular risk, to analyze the contribution of measuring…
- Conditions
- Dyslipaemia, Atherosclerosis Risk, Increased hsCRP, Inflammatory and Oxidative Status in the Spanish Population
- Trial name
- DARIOS (NCT00998062)
- Where
- 11 sites in Spain
- Volunteers
- 30,181 people
- Sponsor
- AstraZeneca
Peripheral Artery Disease
BRight DCB First-in-Human Study
The primary aim of this clinical study is to assess the safety and clinical performance of the BRight drug-coated balloon (DCB) in the treatment of lower limb arteries stenosis in subjects with Peripheral Artery Disease (PAD).
- Trial name
- NCT04525794
- Testing
- BRight DCB
- Where
- 7 sites in Australia, Austria and 2 more
- Volunteers
- 48 people
- Sponsor
- Biotronik CRC Inc.
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, Peripheral Vascular Diseases
Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon
PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due…
- Trial name
- PREVEIL (NCT02648620)
- Testing
- SurVeil Drug Coated Balloon, Angioplasty
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- SurModics, Inc.
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
Hypercholesterolemia
Safety Study of Bile Acid to Treat Hypercholesteremia
Preclinical data support the hypothesis that the administration of AHRO-001 reduces LDL cholesterol levels, improves HDL function, and finally, decreases atheromatous plaque burden.
- Trial name
- NCT01931241
- Testing
- AHRO-001
- Where
- Russia
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- AtheroNova Inc.
Hypercholesterolaemia, Atherosclerosis
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.
- Trial name
- NCT00653835
- Testing
- Ezetimibe + Simvastatin, Simvastatin
- Volunteers
- 153 people
- Sponsor
- Organon and Co
Atherosclerosis, Peripheral Artery Disease
BIOLUX P-III All-Comers Passeo-18 Lux Registry
BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic…
- Trial name
- NCT02276313
- Testing
- Passeo-18 Lux
- Where
- 45 sites in Australia, Austria and 14 more
- Volunteers
- 880 people
- Sponsor
- Biotronik AG
Peripheral Vascular Disease
Endovascular Atherectomy Safety and Effectiveness Study
The purpose of this study is to evaluate the procedural safety and effectiveness of the Phoenix Atherectomy™ System for the treatment of de novo and restenotic atherosclerotic lesions located in the native peripheral arteries.
- Trial name
- EASE (NCT01541774)
- Testing
- Phoenix Atherectomy System
- Where
- 16 sites in United States, Germany
- Volunteers
- 128 people
- Sponsor
- AtheroMed, Inc
Atherosclerosis
To Estimate the Potential Effects of Repeat Doses of Darapladib on the Pharmacokinetics (PK) of Rosuvastatin as Well as Evaluating Safety and Tolerability in Healthy Volunteers
The potential for a drug interaction between Darapladib and Rosuvastatin is felt to be low and it would be helpful to quantify this risk in man in order to guide prescribing physicians.
- Trial name
- NCT01751074
- Testing
- Rosuvastatin 10 mg, Darapladib 160 mg
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Peripheral Arterial Disease
BIOLUX P-IV CHINA ( BIOTRONIK )
Prospective, multi-center, non-randomized clinical trial with follow-up investigations at 1, 6 and 12 months. To confirm safety and efficacy of Passeo-18 Lux DCB in new and non-stented re-stenotic lesions in the superficial…
- Trial name
- NCT02912715
- Testing
- Paclitaxel releasing angioplasty balloon
- Where
- China
- Volunteers
- 158 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Carotid Artery Disease, Carotid Stenosis
Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)
To collect clinical outcome and device performance data on the FDA 510(k)-cleared Emboshield® BareWire™ Rapid Exchange Embolic Protection System and FDA-approved Xact® Rapid Exchange Carotid Stent System when used under…
- Conditions
- Carotid Artery Disease, Carotid Stenosis, Stroke, Atherosclerosis
- Trial name
- NCT00287508
- Testing
- Carotid artery stenting with filter (interventional)
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices