Clinical trials: Coronary Calcified Disease
Coronary Artery Disease
Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)
Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the…
- Trial name
- NCT02650128
- Testing
- Shockwave Coronary Rx Lithoplasty® System
- Where
- 7 sites in Australia, France and 3 more
- Volunteers
- 60 people
- Sponsor
- Shockwave Medical, Inc.
Calcification of Coronary Artery
Coronary Atherectomy System in Patients With Coronary Calcification (CORECT)
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary atherectomy system for the treatment of patients with coronary calcification.
- Trial name
- NCT05447585
- Testing
- Coronary atherectomy system of Shanghai MicroPort Rhythm, Rotablator Rotational Atherectomy System
- Where
- China
- Volunteers
- 239 people
- Sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
Heart Valve Disease, Aortic Stenosis
Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications
Intervention study focused on preventing the progression of aortic valve calcification. Vascular and cardiac calcifications are a marker of risk and poor outcome, especially the severe calcified aortic stenosis and coronary…
- Trial name
- CALCIFICA (NCT01000233)
- Testing
- Phytine (phytate)
- Where
- Spain
- Volunteers
- 250 people
- Sponsor
- Hospital Universitari Son Dureta
Coronary Artery Disease, Calcification
CRUSTAL Study in China
This is a prospective, multicenter, single-arm registry study, aimed to evaluate the clinical outcomes of using Shockwave IVL catheter in the treatment of coronary artery calcification in real-world clinical practice.
- Trial name
- NCT05828186
- Testing
- Shockwave Coronary Intravascular Lithotripsy (IVL) catheter
- Where
- 6 sites in China
- Volunteers
- 200 people
- Sponsor
- First Affiliated Hospital of Guangxi Medical University
Coronary Artery Disease
Novel Imaging Approaches To Identify Unstable Coronary Plaques
Cardiovascular disease is the leading cause of death in Scotland and the Western World. Approaches to improve the identification of vulnerable or ruptured coronary atherosclerotic plaques are urgently needed to help risk…
- Trial name
- NCT01749254
- Where
- United Kingdom
- Volunteers
- 80 people
- Sponsor
- University of Edinburgh
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV EU-EFS
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical…
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Failure
- Trial name
- NCT06510855
- Testing
- DurAVR™ THV System
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Atherosclerosis
Strategy for Unstable Coronary Plaque in Patients Presenting to Emergency Department for Chest Pain Suspected of Coronary Artery Disease
Primary prevention of coronary disease and especially its major complication, inaugural myocardial infarction, is based on any prodromal symptoms identification and on risk profile establishment.
- Trial name
- SPECTRE (NCT06013722)
- Testing
- 18F-Na PET Scan
- Where
- Monaco
- Volunteers
- 22 people
- Sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Type 1 Diabetes, Coronary Artery Calcifications
Relation of Visceral Fat and Associated Cytokines With Early Cardiovascular Complications in Type 1 Diabetes.
Objective: To investigate whether visceral adipose tissue (VAT) and its adipokines contribute to early signs of cardiovascular disease, meaning coronary artery calcifications (CAC) and diastolic dysfunction in type 1 diabetes…
- Conditions
- Type 1 Diabetes, Coronary Artery Calcifications, Diastolic Dysfunction
- Trial name
- VISCERA (NCT02689570)
- Testing
- observational
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- University Hospital, Antwerp
Coronary Calcified Disease
Clinical Trials of Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater
The prospective, multicenter, single- arm study is designed to verify the safety and efficacy of pulsed sonic balloon dilatation catheter and pulsed sonic generater in the treatment of coronary calcification lesions.
- Trial name
- NCT05406869
- Testing
- Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater
- Where
- 14 sites in China
- Volunteers
- 170 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Cardio Vascular Disease
An Study Looking at Percutaneous Coronary Intervention Outcomes for Octogenarians
The goal of this observational study is to understand the makeup of the participants aged 80 years and older who had stents fitted or balloon expansion of their heart arteries, otherwise known as percutaneous coronary…
- Trial name
- NCT07633964
- Testing
- Percutaneous Coronary Intervention
- Where
- United Kingdom
- Volunteers
- 850 people
- Sponsor
- Gloucestershire Hospitals NHS Foundation Trust
Aortic Stenosis, Imaging
Mechanisms Of Disease Progression in Aortic Stenosis - the MODAS Study
Biomarkers and mechanisms in the progression of aortic valve stenosis are sometimes not sufficiently understood. The current project will take into account image morphological and immunological aspects that predict the…
- Conditions
- Aortic Stenosis, Imaging, Pathogenesis, Disease Progression
- Trial name
- NCT05851209
- Where
- 3 sites in Germany
- Volunteers
- 938 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Moderate Aortic Valve Stenosis
Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
- Trial name
- KATALYST-AV (NCT07001800)
- Testing
- Ataciguat
- Where
- 74 sites in United States, Canada
- Volunteers
- 1,276 people
- Sponsor
- Kardigan, Inc.
End-stage Kidney Disease
Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients
The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo.
- Trial name
- iPACK-HD (NCT01528800)
- Testing
- Vitamin K1, Microcrystalline Methylcellulose
- Where
- 3 sites in Canada
- Volunteers
- 85 people
- Sponsor
- Dr. Rachel Holden
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
Safety Issues, Efficacy, Self
The Lower Silesia Shockwave Registry
Lower Silesia Shockwave Registry (LSSR), is a observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of shockwave intravascular lithotripsy in two…
- Trial name
- LSSR (NCT05916898)
- Testing
- PCI with support of Shockwave Intravascular Lithotripsy
- Where
- 2 sites in Poland
- Volunteers
- 400 people
- Sponsor
- Miedziowe Centrum Zdrowia SA
Peritoneal Dialysis
Alendronate for Vascular Calcification in Peritoneal Dialysis Patients?
Hyperphosphatemia is frequently seen in patients with end-stage renal disease (ESRD). Hyperphosphatemia usually results in a high calcium-phosphorus product (CPP) which may subsequently lead to artery and become a risk factor of…
- Trial name
- NCT00299572
- Testing
- alendronate (Fosamax)
- Where
- Taiwan
- Volunteers
- 50 people
- Sponsor
- Far Eastern Memorial Hospital
Calcified Coronary Artery Disease
ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2
The ISAR-CALC 2 trial is an investigator-initiated, prospective, randomized, multicenter, assessors-blind, open-label other clinical investigation.
- Trial name
- ISAR-CALC2 (NCT05072730)
- Testing
- Super High Pressure Balloon (OPN NC), Intravascular lithotripsy (IVL)
- Where
- 6 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Valve Stenosis
Microparticles in Severe Aortic Stenosis
Microparticles are small cell fragments that can induce fat plaques, calcification and formation of thrombus. They can be released through multiple stimulations, but also the high flow of blood through partially obstructed aortic…
- Trial name
- NCT02193035
- Testing
- Microparticle levels
- Where
- Brazil
- Volunteers
- 15 people
- Sponsor
- InCor Heart Institute
Coronary Artery Disease
Atherectomy vs Intravascular Lithotripsy
Preliminary experiences show that IVL is promising for achieving an effective plaque modification at time of PCI. However, uncertainty about the optimal tool to select in case of calcification of coronary lesions exists, as no…
- Trial name
- RAINBOW (NCT04013906)
- Testing
- Rotational atherectomy
- Volunteers
- 100 people
- Sponsor
- University of Roma La Sapienza
Primary Prevention, Vascular Calcification
GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification
A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with…
- Trial name
- NCT06722521
- Testing
- Pitavastatin 4mg and ezetimibe 10mg, taken once daily, Pitavastatin 2 mg with aspirin 100 mg, taken once daily.
- Where
- South Korea
- Volunteers
- 7,435 people
- Sponsor
- Asan Medical Center