Clinical trials: Coronary Calcified Disease
Coronary Artery Disease, Myocardial Infarction
Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)
This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo…
- Trial name
- NCT05966662
- Testing
- IVL with Shockwave C2+ 2Hz Coronary IVL Catheter
- Where
- 18 sites in United States
- Volunteers
- 145 people
- Sponsor
- Shockwave Medical, Inc.
Hypertension, Aortic Stenosis, Calcific
Pressure Assessment to Improve Outcomes After TAVR: a Registry
At the Malcom Randall Veterans Affairs Medical Center (MRVAMC), invasive cardiac pressures are routinely recorded after transcatheter aortic valve replacement (TAVR) procedures.
- Conditions
- Hypertension, Aortic Stenosis, Calcific, Quality of Life, Heart Failure With Preserved Ejection Fraction
- Trial name
- NCT03923530
- Testing
- Eplerenone
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- North Florida Foundation for Research and Education
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.
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Disease
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.
- Trial name
- EMPOWER CAD (NCT05755711)
- Testing
- Shockwave Medical Coronary IVL System
- Where
- 49 sites in United States, France and 3 more
- Volunteers
- 399 people
- Sponsor
- Shockwave Medical, Inc.
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, 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.
Chronic Kidney Disease, Vitamin D Deficiency
Vitamin D and Coronary Calcification Study
Patients with chronic kidney disease (CKD) have a higher mortality rate than the general population, with cardiovascular disease (CVD) accounting for approximately 50% of deaths.
- Conditions
- Chronic Kidney Disease, Vitamin D Deficiency, Coronary Calcification, Disorders of Calcium and Bone Metabolism
- Trial name
- VCOR (NCT00752102)
- Testing
- Calcitriol (Rocaltrol®), Paricalcitol
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Joslin Diabetes Center
Coronary Artery Disease, Myocardial Infarction
Disrupt CAD III With the Shockwave Coronary IVL System
The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic…
- Trial name
- NCT03595176
- Testing
- Lithotripsy
- Where
- 48 sites in United States, France and 2 more
- Volunteers
- 431 people
- Sponsor
- Shockwave Medical, Inc.
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
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
Atrial Fibrillation
Apixaban Versus Warfarin in the Evaluation of Progression of Atherosclerotic Calcification and Vulnerable Plaque
Vitamin K-antagonists (VKA) such as warfarin are the most widely used blood thinners for irregular heart beats like atrial fibrillation.
- Trial name
- NCT02090075
- Testing
- apixaban, warfarin
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Aortic Valve Stenosis
A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification
The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows progression of valve calcification in patients with moderate calcific aortic valve stenosis.
- Trial name
- CAVS (NCT02481258)
- Testing
- Ataciguat (HMR1766)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Mayo Clinic
Chronic Kidney Disease, End Stage Renal Disease
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the…
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease, Coronary Artery Calcification, Vascular Calcification
- Trial name
- NCT00379899
- Testing
- cinacalcet
- Volunteers
- 360 people
- Sponsor
- Amgen
Coronary Atherosclerosis, Coronary Artery Calcification
Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)
1. Statement of Problem According to the National Fire Protection Association (NFPA), 43.7% of all firefighters that died on the job experienced sudden cardiac death. The job also affords an incredible amount of stress.
- Conditions
- Coronary Atherosclerosis, Coronary Artery Calcification, Coronary Stenosis
- Trial name
- NCT00860847
- Testing
- Aged garlic extract and Coenzyme Q10
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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
Aortic Valve Stenosis
The Effect of Lipitor on Aortic Stenosis
The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic…
- Trial name
- NCT00590135
- Testing
- atorvastatin (Lipitor)
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- The Cleveland Clinic
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Mitral Insufficiency
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular…
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Annular Calcification, Mitral Annulus Calcification
- Trial name
- NCT03539458
- Testing
- Tendyne Mitral Valve System
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- Abbott Medical Devices
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Cerebral Protection in Transcatheter Aortic Valve Replacement
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior…
- Trial name
- NCT02214277
- Testing
- Cerebral Protection System-The SENTINEL System with TAVR, TAVR
- Where
- 15 sites in United States, Germany
- Volunteers
- 363 people
- Sponsor
- Claret Medical