Clinical trials: Coronary Calcified Disease
Coronary Artery Disease, Atherosclerosis
Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material.
- Trial name
- ROTA-CUT (NCT04865588)
- Testing
- rotational atherectomy, cutting balloon, plain old balloon
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
Coronary Artery Disease
The Prospective Segeberg Registry for Rotational Atherectomy in Coronary Lesion/s
A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing a Rotational Atherectomy in Coronary Lesion/s
- Trial name
- NCT04011527
- Testing
- Rotational Atherectomy in Coronary Lesion/s
- Where
- Germany
- Volunteers
- 1,500 people
- Sponsor
- Segeberger Kliniken GmbH
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
Coronary Artery Perforation, Coronary Stent Occlusion
Glasgow Natural History Study Of Covered Coronary Interventions
Covered stents (CS) are a potentially lifesaving treatment for grade III coronary perforation but delivery can be challenging, and the long-term durability and safety including risk of acute stent thrombosis are unknown.
- Conditions
- Coronary Artery Perforation, Coronary Stent Occlusion, Stent Thrombosis
- Trial name
- GNOCCI (NCT03862352)
- Testing
- Covered coronary stent
- Where
- United Kingdom
- Volunteers
- 161 people
- Sponsor
- NHS National Waiting Times Centre Board
Calcified Atheroma, Coronary Artery Disease
ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, the SONAR Trial
Percutaneous coronary interventions (PCI) is intended to relieve myocardial ischemia by improving blood flow in the epicardial coronary arteries.
- Trial name
- SONAR (NCT05208749)
- Testing
- Rotablation of shockwave
- Where
- Belgium
- Volunteers
- 170 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Aortic Stenosis
Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis
The aortic valve is the main outlet valve from the heart. This valve can become diseased and narrowed when it needs to be replaced with an artificial valve.
- Trial name
- NCT01358513
- Where
- United Kingdom
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
Atherosclerosis, Coronary Artery Disease
Efficacy CompariSon of Pre-stenting Atherectomy Versus Scoring ballooN for calcifieD Coronary Lesions Coronary Lesions
Design: The proposed study is a randomized study comparing the relative effectiveness of three lesion modification strategies (RA, SBS, or OAS) in the treatment of obstructive CCLs using the change in lumen size measurements…
- Trial name
- ECSPAND (NCT02819531)
- Testing
- Rotational atherectomy, Orbital atherectomy, Scoring balloon system
- Volunteers
- 30 people
- Sponsor
- North Texas Veterans Healthcare System
Coronary Artery Disease
Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
The objective of this study is to assess the current standard of care treatment outcome in none/mild, moderate and severely calcified coronary lesions using: A composite of MACE at 30-day and one (1) year post procedure, and…
- Trial name
- MACE (NCT01930214)
- Testing
- Percutaneous Coronary Intervention
- Where
- 34 sites in United States
- Volunteers
- 350 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease (CAD), Coronary Calcification
AERO CAD Study Evaluating the Shockwave C2 Aero IVL System in Coronary Artery Disease
The AERO CAD study is a prospective, multi-center, single-arm, post-market clinical investigation evaluating the procedural performance and clinical outcomes of the Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL)…
- Conditions
- Coronary Artery Disease (CAD), Coronary Calcification, Coronary Calcified Disease, Coronary Calcified Nodules
- Trial name
- AERO CAD (NCT07512206)
- Testing
- Shockwave C2 Aero Coronary IVL System
- Where
- 8 sites in United States
- Volunteers
- 200 people
- Sponsor
- OPCI Core Laboratories LLC
Aortic Regurgitation Disease, Aortic Valve Calcification
Valvular Assessment of New Generation Aortic Replacement Devices
The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement…
- Conditions
- Aortic Regurgitation Disease, Aortic Valve Calcification, Bicuspid Aortic Valve Disease
- Trial name
- VANGUARD (NCT06688448)
- Testing
- Dafodil prosthesis, Aortic Valve Replacement - Inspires Resilia prosthesis
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Breast Cancer, Vascular Calcification
Tissue Validation of Mammographic Breast Arterial Calcification in Mastectomy Specimens
Breast arterial calcification (BAC) is a common incidental finding on screening mammograms and has been associated with cardiovascular disease in women. However, every study in this field has been imaging-based.
- Conditions
- Breast Cancer, Vascular Calcification, Coronary Artery Calcification, Atherosclerosis Cardiovascular Disease
- Trial name
- SIDEMARA (NCT07865884)
- Volunteers
- 100 people
- Sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Aortic Stenosis
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance…
- Trial name
- NCT04815785
- Testing
- TaurusOne® transcatheter aortic valve replacement system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Coronary Artery Disease, Aortic Valve Disease
Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
The goal of the 3D-CARDIOPATH study is to investigate the potential added value of emerging 3D imaging modalities by imaging ex vivo cardiac specimens (diseased coronary arteries, calcific aortic valves, and thrombotic materials)…
- Conditions
- Coronary Artery Disease, Aortic Valve Disease, Aortic Valve Calcification, STEMI
- Trial name
- 3D-CARDIOPATH (NCT05975567)
- Testing
- Three-dimensional imaging of the collected cardiac specimens
- Volunteers
- 70 people
- Sponsor
- Aristotle University Of Thessaloniki
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 Artery Calcification, HIV Infections
French CAC-HIV Cohort Study
Clinical study: Methods: observational transversal two-arm cohort study including adults living with HIV (PLHIV) and HIV negative subjects (HIV-) at intermediate cardiovascular risk.
- Trial name
- CAC-HIV (NCT05563116)
- Testing
- Computed tomography coronary artery calcium (CAC) score (part of routine workup)
- Volunteers
- 689 people
- Sponsor
- Franck Boccara
Coronary Artery Disease
The Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in CAD Patients With Diabetes Mellitus
This study is designed to validate the hypothesis that the treatment of rosuvastatin could increase the score of Calcification of Coronary artery(CAC) density in coronary artery disease(CAD) patients with diabetes mellitus.CAD…
- Trial name
- NCT02418884
- Testing
- rosuvastatin
- Volunteers
- 122 people
- Sponsor
- Sir Run Run Shaw Hospital
Coronary Artery Disease
Rotational Atherectomy for Calcified lEsion By Smart Angioplasty Research Team (SMART-RACE)
Current guidelines recommend the use of rotational atherectomy (RA) for preparation of heavily calcified or severely fibrotic lesions that cannot be crossed by a balloon or adequately dilated before planned stenting (bailout…
- Trial name
- NCT02716363
- Testing
- Rotational Atherectomy by Rotablator
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Samsung Medical Center
Coronary Artery Disease (CAD), Coronary Artery Calcification
Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT)
SUSPECT is a prospective, single-center, cohort study of 250 military aircrew at the Center for Man in Aviation, Royal Netherlands Air Force.
- Conditions
- Coronary Artery Disease (CAD), Coronary Artery Calcification, Occupational Diseases, Aviator's; Disease
- Trial name
- SUSPECT (NCT05508893)
- Testing
- CT Angiography, Exercise stress test
- Where
- 2 sites in Netherlands
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- UMC Utrecht
Coronary Artery Disease, Calcification
Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions
Percutaneous coronary intervention (PCI) is the standard treatment for patients with coronary artery disease who have an indication for surgery.
- Trial name
- NCT06669195
- Testing
- Intravascular lithotripsy group, high-pressure balloon group
- Volunteers
- 40 people
- Sponsor
- Xuzhou Third People's Hospital