Clinical trials: Coronary Calcified Disease
Coronary Disease, Coronary Artery Disease
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization.
- Conditions
- Coronary Disease, Coronary Artery Disease, Calcific Coronary Arteriosclerosis, Stent Restenosis
- Trial name
- VICTORY (NCT05346068)
- Testing
- OPN™ NCB Super High Pressure PCI Balloon, Shockwave™ C2 IVL Catheter
- Where
- Switzerland
- Volunteers
- 280 people
- Sponsor
- Luzerner Kantonsspital
Aortic Valve Stenosis
Valvular Aortic Stenosis: Study of Myocardiac Fibrosis by Magnetic Resonance Imagery
Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography Doppler, which assesses two key markers that are…
- Trial name
- RACINE (NCT02551588)
- Testing
- Valvular aortic stenosis surgery
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Coronary Artery Disease, Calcifications Vascular
SOLSTICE Trial in China
This is a small sample size clinical trial in Chinese population to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System to treat de novo, calcified, stenotic, coronary lesions…
- Trial name
- NCT05433376
- Testing
- Shockwave Coronary Intravascular Lithotripsy (IVL) System C2
- Where
- 3 sites in China
- Volunteers
- 20 people
- Sponsor
- Genesis Medtech Corporation
Coronary Artery Disease, Hypercholesterolemia
A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical Atheroma
The main aim of this trial is to demonstrate that Evolocumab plus routine lipid management is superior to routine lipid management alone in modifying plaque (non-calcified) volume as measured by Artificial Intelligence-enabled…
- Conditions
- Coronary Artery Disease, Hypercholesterolemia, Atheroma, Atherosclerotic Plaque
- Trial name
- NCT07803679
- Testing
- Evolocumab, Routine Lipid Management, Autoinjector
- Volunteers
- 308 people
- Sponsor
- Amgen
Vascular Calcification, Chronic Kidney Diseases
a-Klotho in Relation to Calcification in the Coronary Arteries and Aortic Valve in Patients With Chronic Kidney Disease
To define the correlation of the levels of a-Klotho with the severity of vascular calcification in the coronary arteries and aortic valve.
- Trial name
- NCT03858413
- Testing
- No intervention
- Volunteers
- 60 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
The goal of this observational study is to better understand how the amount of insulin people with type 1 diabetes are using relates to blood glucose control and the risk of complications.
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD), Severe Albuminuria, Estimated Glomerular Filtration Rate (eGFR)
- Trial name
- iDose-EDC (NCT07911033)
- Testing
- Routine/prescribed exogenous insulin dose
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Rachel Miller
Aortic Valve Stenosis, Aortic Valve Insufficiency
Clinical Investigation for the Foldax Tria Aortic Heart Valve- India
The purpose of this study is to conduct a clinical investigation of the Foldax Tria Aortic Valve to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- NCT06192706
- Testing
- Foldax Tria Aortic Valve
- Where
- 10 sites in India
- Volunteers
- 50 people
- Sponsor
- Foldax, Inc
Diabetes, Coronary Artery Calcification
A Study Comparing Skin Fluorescence to Coronary Artery Calcification
This study examines the relationship between the SCOUT DM device and coronary artery calcification as determined by rapid computed tomography in patients at risk for coronary heart disease.
- Trial name
- CACS (NCT00895427)
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- VeraLight, Inc.
Aortic Valve Disease, Aortic Valve Stenosis
Myeloid Cells in Aortic Valve Stenosis
Investigators plan to characterize systemic inflammation and circulating immune cells in participants with moderate and severe calcific aortic valve disease and matched healthy controls.
- Trial name
- MIRACLE (NCT04717219)
- Testing
- Blood drawing
- Where
- 3 sites in Netherlands
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
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.
Aortic Valve Calcification, Aortic Stenosis
Prevalence and Significance of Mutations in Genes Encoding NaPi-co-transporters in the Development of CAVD
Mutations in the SLC34A2 gene, that encodes the sodium phosphate co-transporter (NaPi-IIb), cause defect cell-uptake of phosphate, which leads to formation of calcium-phosphate concretions in the lungs as seen in Pulmonary…
- Trial name
- NCT02516800
- Where
- Denmark
- Volunteers
- 600 people
- Sponsor
- University of Aarhus
Coronary Artery Calcification
Coronary Intravascular Lithotripsy System in Patients With Coronary Artery Calcification (VIGOUR)
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary intravascular lithotripsy system for the treatment of patients with coronary calcification.
- Trial name
- NCT05818098
- Testing
- Intravascular Lithotripsy System of Shanghai MicroPort Rhythm
- Where
- China
- Volunteers
- 189 people
- Sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
End Stage Renal Disease
Risk Factors for Coronary Artery Calcification and Left Ventricular Hypertrophy in Hemodialysis Patients
Individuals with kidney disease are at a higher risk for heart and vascular diseases, including heart attacks and strokes, than those with normal kidney function.
- Trial name
- NCT01427374
- Where
- 4 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- University of Alberta
Atherosclerotic Cardiovascular Disease, Cardiovascular Diseases
Immunomodulatory Effects of PCSK9 Inhibition
Cardiovascular disease (CVD) represents the leading cause of death worldwide. While medications, such as statins, significantly reduce atherosclerotic CVD (ASCVD) risk by lowering low density lipoprotein levels, they may also…
- Conditions
- Atherosclerotic Cardiovascular Disease, Cardiovascular Diseases, Atherosclerosis, Arterial Inflammation
- Trial name
- INSPIRAR (NCT05720156)
- Testing
- 99mTc-tilmanocept SPECT/CT scanning
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Mitral Valve Disease
Mitral Implantation of TRAnscatheter vaLves
The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular…
- Trial name
- MITRAL (NCT02370511)
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 15 sites in United States
- Volunteers
- 91 people
- Sponsor
- Mayra Guerrero
Aortic Valve Disease, Aortic Valve Stenosis
Evaluation of the Inflammatory Response in Post-operated Aortic Valve Replacement Patients.
Background Calcification of the aortic valve affects more than 26% of adult patients over 65 years of age and is the main indication for valve replacement in the United States of America.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Prosthetic Valve Malfunction
- Trial name
- NCT04557345
- Testing
- Determination of cytokines, Two-dimensional transthoracic echocardiogram
- Where
- Mexico
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
Calcified Coronary Lesions, ST Elevated Myocardial Infarction
European Registry On Plaque ModifiCAtion in the STEMI Population (ROCA-STEMI)
This is an European prospective cohort study from February 2023 until February 2024. The investigators want to analyze the clinical success, efficacy and safety of consecutive patients who presented with ST-elevation myocardial…
- Conditions
- Calcified Coronary Lesions, ST Elevated Myocardial Infarction, Plaque Modification Technique
- Trial name
- ROCA-STEMI (NCT05752617)
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- Hospital del Mar
Chronic Kidney Disease, Coronary Arteries Calcifications
CXCR2 Leucocyte Expression Level as a Predictive Factor of Coronary Artery Calcification Progression in Advanced Chronic Kidney Disease Patients
Chronic kidney disease (CKD) is associated with the development of coronary arteries calcifications (CAC) and increased cardiovascular mortality.
- Conditions
- Chronic Kidney Disease, Coronary Arteries Calcifications, CXCR2 Expression
- Trial name
- MACXCALCIF (NCT07811505)
- Testing
- Thoracic CT, Blood samples
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Aortic Stenosis, Symptomatic Aortic Stenosis
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- DurAVR™ EFS (NCT05712161)
- Testing
- DurAVRTM THV System
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Coronary Artery Disease
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in…
- Trial name
- ISAR-WAVE (NCT06369142)
- Testing
- Intravascular lithotripsy (IVL), Standard non-IVL methods
- Where
- 22 sites in Germany
- Volunteers
- 666 people
- Sponsor
- Deutsches Herzzentrum Muenchen