Clinical trials: Coronary Calcification, open to volunteers
Coronary Arterial Disease (CAD), Calcific Coronary Arteriosclerosis
Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon
The purpose of this clinical study is to evaluate the effectiveness and safety of a specialized medical device, the Naviscore scoring balloon, in preparing calcified coronary artery narrowings before the implantation of a…
- Trial name
- MILOU (NCT07650578)
- Testing
- Scoring Balloon PTCA Catheter, Non-Compliant (NC) Angioplasty Balloon
- Where
- 14 sites in Belgium, Luxembourg and 2 more
- Volunteers
- 200 people
- Sponsor
- University of Mons
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Atherosclerotic Cardiovascular Disease (ASCVD), Coronary Artery Calcification
Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in ASCVD (HEARTWISE-ASCVD)
This multi-site study will test whether an opportunistic AI-based CAC screening and notification intervention can improve cholesterol treatment and lower cholesterol levels in adults.
- Trial name
- HEARTWISE (NCT07355894)
- Testing
- AI-Detected CAC Notification and Care Facilitation
- Where
- 6 sites in United States
- Volunteers
- 120,000 people
- Sponsor
- Stanford University
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 Calcifications, Intravascular Lithotripsy
Intravascular Lithotripsy Versus Rotational Atherectomy for Severe Coronary Artery Calcification: A Prospective, Multicenter, Non-inferiority Randomized Controlled Trial
Severely calcified coronary lesions represent one of the major challenges in interventional cardiology. Severe coronary calcification increases the difficulty and complexity of percutaneous coronary intervention (PCI), impedes…
- Conditions
- Coronary Artery Calcifications, Intravascular Lithotripsy, Rotational Atherectomy, Intravascular Ultrasound
- Trial name
- LIRAC (NCT07750964)
- Testing
- intravascular lithotripsy, rotational atherectomy
- Volunteers
- 190 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Coronary Artery Disease Risk Factors Multiple, Coronary Artery Disease Progression
PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis
Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. This clinical trial will test if screening and early treatment of mild heart disease works.
- Conditions
- Coronary Artery Disease Risk Factors Multiple, Coronary Artery Disease Progression, Prevention & Control, Premature Atherosclerosis
- Trial name
- PRE-EMPT (NCT07232069)
- Testing
- Rosuvastatin 20 Mg Oral Tablet, Colchicine 0.5 MG Oral Tablet Once Daily
- Where
- 23 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Duke University
Coronary Artery Disease, Chronic Renal Failure
Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
The current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion.
- Trial name
- CRATER (NCT05353946)
- Testing
- Percutaneous coronary intervention (PCI)
- Where
- Spain
- Volunteers
- 124 people
- Sponsor
- Guillermo Galeote; MD, PhD
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.
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Stenosis, PCSK9 Inhibitor
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease
The aim of this clinical trial is to understand whether the drug PCSK9 inhibitor can slow the progression of calcific aortic valve disease and to understand the safety of the drug.
- Conditions
- Aortic Stenosis, PCSK9 Inhibitor, Calcified Aortic Valve Disease
- Trial name
- NCT06996223
- Testing
- The Group A received PCSK9 inhibitor plus statin therapy
- Volunteers
- 316 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
VOYAGER CE Clinical Study using the Encantor TAVI System.
- Trial name
- VOYAGER CE (NCT07696182)
- Testing
- Prospective, single-arm, multi-center study.
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
AI-Based CT Analysis of Coronary Plaque Evolution
This retrospective, multicenter, observational study will evaluate an artificial intelligence-based system for quantitative assessment and risk stratification of coronary atherosclerotic plaque.
- Trial name
- AI-CT-PLAQUE (NCT07886996)
- Where
- 5 sites in China
- Volunteers
- 326 people
- Sponsor
- Zhejiang Hospital
Coronary Artery Calcification, Metabolic Syndrome
High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium
The aim of this study is to compare safety and efficacy between the aggressive treatment with combination of high-intensity statin and ezetimibe and the current standard lipid lowering treatment in asymptomatic patients with…
- Conditions
- Coronary Artery Calcification, Metabolic Syndrome, Dyslipidemias
- Trial name
- DECISION-CAL (NCT05845424)
- Testing
- Guideline directed statin therapy, High intensity statin plus ezetimibe therapy
- Where
- South Korea
- Volunteers
- 6,000 people
- Sponsor
- Samsung Medical Center
Coronary Artery Disease (CAD), Calcific Coronary Arteriosclerosis
Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry.
The OROBICA (Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions) Registry is a multicenter, ambispective, real-world observational study designed to evaluate clinical, procedural…
- Conditions
- Coronary Artery Disease (CAD), Calcific Coronary Arteriosclerosis, Intravascular Lithotripsy; Rotational Atherectomy; OFDI, Orbital Atherectomy
- Trial name
- OROBICA (NCT07566403)
- Testing
- Percutaneous coronary intervention with or without stent implantation
- Where
- Italy
- Volunteers
- 3,000 people
- Sponsor
- Papa Giovanni XXIII Hospital
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Cardiovascular Disease (CVD)
Cardiovascular Risk Assessment and Coronary Calcium Score in Thai MASLD Patients
Metabolic dysfunction-associated steatotic liver disease (MASLD) is common in Thailand and is strongly linked to metabolic risk factors such as obesity, diabetes, hypertension, and dyslipidemia.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Cardiovascular Disease (CVD), Coronary Artery Calcification
- Trial name
- MASLD-CAC (NCT07865936)
- Where
- Thailand
- Volunteers
- 251 people, healthy volunteers welcome
- Sponsor
- Watcharasak Chotiyaputta
Mitral Regurgitation, Mitral Stenosis
Abbott Cephea Mitral Valve Disease Registry
The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease, Mitral Valve (MV) Regurgitation
- Trial name
- NCT07069673
- Where
- 24 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Coronary Atherosclerosis Due to Calcified Coronary Lesion
Routine Versus As-Needed Stress Testing in Asymptomatic Patients With High-Risk Coronary Calcium
The purpose of the SMART-EXAM (SMart Angioplasty Research Team-Pragmatic Randomized Trial for Comparing Routine versus As-Needed EXercise or Pharmacologic Stress Testing in Asymptomatic Patients with High-Risk Coronary CalciuM)…
- Trial name
- SMART-EXAM (NCT05796739)
- Testing
- Non-invasive stress test, Medical treatment without further testing
- Where
- South Korea
- Volunteers
- 3,000 people
- Sponsor
- Samsung Medical Center
Aortic Regurgitation, Aortic Disease
Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Disease, Calcified Aortic Valve
- Trial name
- MARVELTAVI (NCT07751965)
- Testing
- Myval THV series
- Volunteers
- 164 people
- Sponsor
- Ceric Sàrl
PCI, Coronary Arterial Disease (CAD)
Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions
this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing…
- Conditions
- PCI, Coronary Arterial Disease (CAD), Calcified Coronary Lesions
- Trial name
- Shape (NCT07093788)
- Testing
- super high-pressure balloon, intravascular lithotripsy (IVL)
- Where
- 3 sites in China
- Volunteers
- 78 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Osteoblast, Vascular Calcification
Use of Discarded Surgery Human Tissue Specimens for Basic Science Research
Although it is now established that calcification process result from the joint and coordinated action of different cell types, many areas of shadow remain regarding the spatio-temporal implementation of these events.
- Trial name
- HumTisRes (NCT04753593)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens