Clinical trials: Coronary Calcified Disease
Coronary Artery Disease
A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter
The objective of the PINNACLE I Clinical Study is to assess safety and performance of the LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX) to treat moderately to severely…
- Trial name
- PINNACLE-I (NCT05828173)
- Testing
- LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX)
- Where
- 7 sites in Belgium, Netherlands
- Volunteers
- 60 people
- Sponsor
- Elixir Medical Corporation
Transcatheter Aortic Valve Replacement
Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System
This study was designed to preliminary verify the safety and of efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With accessories in patients with symptomatic, calcified and severe aortic stenosis using…
- Trial name
- NCT05202977
- Testing
- SinocrownTM Transcatheter Aortic Valve Replacement System
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Stable Angina, Coronary Artery Disease
Impact of Rotational Atherectomy on Coronary Microcirculation
The purpose of this observational study is to compare the impact of rotational atherectomy to conventional stenting and to investigate how it may affect coronary microcirculation in patients with calcified coronary artery lesions…
- Trial name
- MICRO-ROTA (NCT05771961)
- Testing
- coronary pressure/temperature sensor-tipped guidewire, Angiography-derived index of microcirculatory resistance (IMRangio)
- Where
- Lithuania
- Volunteers
- 300 people
- Sponsor
- Lithuanian University of Health Sciences
Coronary Artery Disease, Myocardial Infarction
Disrupt CAD IV With the Shockwave Coronary IVL System
The study design is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries…
- Trial name
- NCT04151628
- Testing
- Lithotripsy
- Where
- 8 sites in Japan
- Volunteers
- 72 people
- Sponsor
- Shockwave Medical, Inc.
Cardiovascular Diseases, Heart Diseases
Coronary Artery Calcification in Type 1 Diabetes
To investigate the occurrence and associated risk factors for subclinical heart disease in persons with insulin-dependent diabetes mellitus (IDDM).
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Diabetes Mellitus
- Trial name
- NCT00005754
- Volunteers
- 1,420 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Atherosclerotic Cardiovascular Disease, Coronary Artery Disease
Incidental Coronary Calcification Quality Improvement Project
This is a multi-center, randomized quality improvement project. At least 200 statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental coronary artery calcium (CAC) on a prior non-gated…
- Trial name
- ICC QI (NCT04789278)
- Testing
- Notification
- Where
- United States
- Volunteers
- 173 people
- Sponsor
- Stanford University
Coronary Arterial Disease (CAD), Coronary Calcification
Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN)…
- Conditions
- Coronary Arterial Disease (CAD), Coronary Calcification, Coronary Calcified Nodules, Orbital Atherectomy
- Trial name
- ORBIT-SHOCK (NCT06736665)
- Testing
- Orbital atherectomy, Intravascular lithotripsy, Optical Coherence Tomography (OCT)
- Where
- 6 sites in Spain
- Volunteers
- 50 people
- Sponsor
- Spanish Society of Cardiology
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
Coronary Artery Disease
Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects.
- Trial name
- ORBIT II (NCT01092416)
- Testing
- Diamondback 360 Orbital Atherectomy System
- Where
- 51 sites in United States
- Volunteers
- 443 people
- Sponsor
- Abbott Medical Devices
Vascular Calcification
Comparison of RA-IVL and RA-SHP in Calcified Coronary Lesions
Study Design Prospective, multicenter, single-blind, randomized controlled trial Hypothesis In patients with severely calcified coronary lesions undergoing rotational atherectomy (Rota), post-rotational lesion optimization using…
- Trial name
- CRUSH-CALC (NCT07279987)
- Testing
- Super High-Pressure Non-Compliant Balloon, Intravascular Lithotripsy System
- Where
- China
- Volunteers
- 162 people
- Sponsor
- Lin Zhao
Coronary Artery Calcification, Coronary Artery Disease
TECTONIC CAD IVL IDE Study
A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites
- Conditions
- Coronary Artery Calcification, Coronary Artery Disease, Stenotic Coronary Lesion
- Trial name
- TECTONIC (NCT06885177)
- Testing
- Experimental
- Where
- 40 sites in United States
- Volunteers
- 335 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Intracoronary Lithotripsy
Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy
Calcified coronary artery disease is a frequently encountered problem that can lead to poorer outcomes for patients undergoing PCI.
- Conditions
- Coronary Artery Disease, Intracoronary Lithotripsy, Optical Coherence Tomography, Percutaneous Coronary Intervention
- Trial name
- NCT04698902
- Testing
- Intracoronary lithotripsy
- Where
- Spain
- Volunteers
- 96 people
- Sponsor
- Fundacion Investigacion Interhospitalaria Cardiovascular
Coronary Artery Calcification
Association Between Non-alcoholic Fatty Liver Disease (NAFLD) and Coronary Artery Calcification
Coronary artery disease are 8 times more prevalent in patients with NAFLD then the general population and are being considered the most common cause of death.
- Trial name
- NCT01158066
- Testing
- CT Cardiac
- Where
- Israel
- Volunteers
- 120 people
- Sponsor
- Ziv Hospital
Coronary Artery Disease, Carotid Artery Disease
Effects of VitamIN K2 and D3 supplementaTion on PET/MRI in Carotid Artery Disease
Atherosclerosis is a disease of the arteries and is the result of various factors such as high blood cholesterol or diabetes, which lead to accumulations of fats, cells, and calcium deposits (i.e. plaques).
- Trial name
- INTRICATE (NCT04010578)
- Testing
- MK-7 and vitamin D3
- Volunteers
- 52 people
- Sponsor
- Academisch Ziekenhuis Maastricht
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
Severe, Symptomatic
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
- Conditions
- Severe, Symptomatic, Calcific Aortic Stenosis
- Trial name
- PARTNERII B (NCT02184442)
- Testing
- TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN
- Where
- 53 sites in United States
- Volunteers
- 560 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Disease, Intravascular Lithotripsy
Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus
This is a prospective, multi-center, single-group target value clinical trial, which will be carried out in many clinical trial institutions in China.
- Trial name
- NCT05649488
- Testing
- Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus, Dragonfly Opstar Imaging Catheter
- Where
- 20 sites in China
- Volunteers
- 184 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
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
Coronary Arterial Disease
Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intravascular Lithotripsy Therapy Device
The FORWARD IVL trial is a Prospective, Multicenter Study conducted to assess the safety and effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter combined with the Intravascular Lithotripsy Therapy…
- Trial name
- FORWARD IVL (NCT07109479)
- Testing
- Intravascular Lithotripsy, Rotational Atherectomy
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Spectrumedics Medical Technology(Shanghai)Co.,Ltd
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