Clinical trials: Vascular Calcification
Healthy
The Efficacy of Vitamin K2 n Human Osteoporosis, Blood-vessel Calcification and Sclerosis
This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation.
- Trial name
- NCT01928134
- Testing
- Vit K2+ Vit D3+ calcium carbonate (CaCO3), Vit K2+CaCO3
- Where
- Taiwan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Changhua Christian Hospital
Pseudoxanthoma Elasticum
What's Happen Under the Calcification Process in Pseudoxanthoma Elasticum
The investigators hypothesize is that in PXE patients, low grade chronic inflammation could preceed the molecular and the clinical calcification process.
- Trial name
- GOCAPXE (NCT03070860)
- Testing
- PET scan 18-FDG and 18-NAF
- Where
- France
- Volunteers
- 23 people
- Sponsor
- University Hospital, Angers
Type 1 Diabetes, Coronary Artery Calcification
Cardiovascular Risk Stratification in Young People With Type 1 Diabetes
The aim of the study is to compare ESC recommendations on cardiovascular (CV) risk stratification with the achievement of a CAC (Coronary Artery Calcification).
- Trial name
- CACD1 (NCT05283538)
- Testing
- Coronary Artery Calcification Realization
- Where
- France
- Volunteers
- 91 people
- Sponsor
- Poitiers University Hospital
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE neo2™ Post Market Clinical Follow up Study
The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT04655248
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Where
- 19 sites in Denmark, Germany and 6 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Coronary Heart Disease
A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly
The aim of this observational study is to compare the prognostic outcomes of various PCI strategies in elderly patients with complex coronary calcified lesions.
- Trial name
- PSSCCE (NCT06168422)
- Testing
- DES, DCB
- Where
- China
- Volunteers
- 2,100 people
- Sponsor
- Henan Institute of Cardiovascular Epidemiology
Stable Angina, Coronary Artery Disease
CCTA, CACS and ECG Stress Testing in Patients With Suspected CAD: Precision Phenotyping and Financial Evaluation
The "DATASET-PRECISE", a 3-arm parallel randomized study, aims to provide new insights in risk stratification of patients with suspected CAD in the Greek population.
- Conditions
- Stable Angina, Coronary Artery Disease, Atherosclerosis, Coronary Artery Calcification
- Trial name
- DATASET (NCT04424121)
- Testing
- CCTA
- Where
- 3 sites in Greece
- Volunteers
- 900 people
- Sponsor
- Aristotle University Of Thessaloniki
Cardiovascular Diseases, Arteriosclerosis
Registry of Coronary Lithotripsy in Spain.
The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease.
- Conditions
- Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
- Trial name
- REPLICA (NCT04298307)
- Testing
- Intracoronary lithotripsy (ICL)
- Where
- 26 sites in Spain
- Volunteers
- 426 people
- Sponsor
- Fundación EPIC
Cardiovascular Diseases, Atherosclerosis
The AI-CAC Model for Subclinical Atherosclerosis Detection on Chest X-ray
The AI-CAC model is an artificial intelligence system capable of assessing the presence of subclinical atherosclerosis on a simple chest radiograph.
- Conditions
- Cardiovascular Diseases, Atherosclerosis, Coronary Artery Calcification
- Trial name
- AI-CAC-PVS (NCT06301009)
- Testing
- AI-CAC score
- Volunteers
- 500 people
- Sponsor
- A.O.U. Città della Salute e della Scienza
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia
ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice.
- Trial name
- ORACLE (NCT07270562)
- Testing
- Stealth 360™ Peripheral Orbital Atherectomy System from Abbott
- Where
- United Kingdom
- Volunteers
- 250 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Cardiovascular Diseases
ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography
The primary objective of the ASA-3C trial is to evaluate the role of aspirin and high-intensity statin therapy, respectively, in individuals with severe coronary calcification (coronary calcium score ≥300) to prevent…
- Trial name
- ASA-3C (NCT06676280)
- Testing
- Aspirin, High-intensity statin, Guideline-directed statin therapy
- Where
- 32 sites in South Korea
- Volunteers
- 5,000 people
- Sponsor
- Jung-min Ahn
Coronary Artery Disease
Coronary Flow Reserve Following Orbital Atherectomy
The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.
- Trial name
- NCT02339545
- Testing
- Coronary Orbital Atherectomy plus Stenting
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Abbott Medical Devices
Vascular Calcification, Atherosclerosis
Association of Bone Quality and Quantity With Vascular Calcification
The purpose of this study is to determine if there is a link between calcium build up in the veins or arteries (including the veins/arteries of the heart) and deterioration of the bone.
- Conditions
- Vascular Calcification, Atherosclerosis, Bone Density
- Trial name
- NCT00892853
- Testing
- CT of the bones
- Where
- United States
- Sponsor
- University of Michigan
Coronary Artery Disease, Severe Coronary Artery Disease
Lithotripsy Versus Balloon Angioplasty for Optimal Treatment of CAlcified Lesions With and Without Optical Coherence Tomography evaluatION
Severely calcified coronary artery disease means that calcium has built up in the blood vessels that supply the heart. This makes coronary procedures more difficult and increases the risk of complications during and after…
- Conditions
- Coronary Artery Disease, Severe Coronary Artery Disease, Coronary Artery Calcification
- Trial name
- LOCATION (NCT07388030)
- Testing
- IVL Pretreatment + OCT-Guided Stent Implantation, IVL Pretreatment + Angiography-Guided Stent Implantation, Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent Implantation
- Where
- China
- Volunteers
- 3,060 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Coronary Artery Calcification, Coronary Artery Disease
MAP-Calcification: MicroRNAs as Potential Biomarkers for Coronary Artery Calcification
Coronary artery disease (CAD) remains the leading cause of mortality in the UK with an estimated 80,000 fatalities in 2010. Coronary artery calcification (CAC) is associated with atherosclerotic plaque burden and cardiovascular…
- Conditions
- Coronary Artery Calcification, Coronary Artery Disease, Osteoporosis, Osteopenia
- Trial name
- NCT01992848
- Testing
- Venous blood sampling, 4-day food diary, 1 week UV dosimeter
- Where
- 2 sites in United Kingdom
- Volunteers
- 45 people
- Sponsor
- University of Surrey
Coronary Arterial Disease (CAD)
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment…
- Trial name
- POWER CAD I (NCT07510438)
- Testing
- Pulse Intravascular Lithotripsy (Pulse IVL)
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 15 people
- Sponsor
- Amplitude Vascular Systems, Inc.
Coronary Artery Disease
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.
- Trial name
- EMPOWER CAD (NCT05755711)
- Testing
- Shockwave Medical Coronary IVL System
- Where
- 49 sites in United States, France and 3 more
- Volunteers
- 399 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Artery Disease, Myocardial Infarction
Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)
This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo…
- Trial name
- NCT05966662
- Testing
- IVL with Shockwave C2+ 2Hz Coronary IVL Catheter
- Where
- 18 sites in United States
- Volunteers
- 145 people
- Sponsor
- Shockwave Medical, Inc.
Peripheral Artery Disease, Peripheral Artery Stenosis
The THOR IDE Study
The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).
- Conditions
- Peripheral Artery Disease, Peripheral Artery Stenosis, Peripheral Artery Calcification, PAD
- Trial name
- THOR (NCT05916950)
- Testing
- Thor laser atherectomy
- Where
- 29 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Atherosclerosis and Calcific Aortic Stenosis with and Without Diabetes
Potential Role of Sirtuins As Epigenetic Biomarkers of the Patient with Atherosclerosis or Calcific Aortic Stenosis
The project aims to shed light on the role of Sirtuins, enzymes belonging to the third class of histone deacetylases (class III) involved in epigenetic modifications (deacetylation), focusing mainly on Sirtuin 6 (SIRT6), as a…
- Trial name
- NCT06337227
- Testing
- lncRNA signature analyses
- Where
- Italy
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- IRCCS SYNLAB SDN
Pseudoxanthoma Elasticum
PPI Supplementation to Fight ECtopIc Calcification in PXE
Pseudoxanthoma elasticum (PXE) is a rare inherited metabolic disorder (OMIM 264800, frequency 1/25000) characterized by progressive ectopic calcification of connective tissues.
- Trial name
- PROPHECI-PPI (NCT04868578)
- Testing
- study treatment PPI
- Where
- 2 sites in France
- Volunteers
- 99 people
- Sponsor
- Centre Hospitalier Universitaire de Nice