Clinical trials: Coronary Calcified Disease
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
Mitral Annular Calcification, Mitral Stenosis
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥…
- Conditions
- Mitral Annular Calcification, Mitral Stenosis, Mitral Regurgitation, Mitral Valve Disease
- Trial name
- MITRAL-II (NCT04408430)
- Testing
- Transseptal ViMAC
- Where
- 17 sites in United States, Mexico
- Volunteers
- 210 people
- Sponsor
- Mayra Guerrero
Coronary Disease
Detection of Coronary Artery Calcification: Comparison of Volumetric and Electron Beam Computed Tomography
Electron beam computed tomography (EBCT) has been regarded as the state-of-the-art investigation for detecting and quantitating coronary artery calcification.
- Trial name
- NCT00001836
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Calcified Coronary Artery Disease (Grade 3)
A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions
The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC)…
- Trial name
- ISAR-CALC (NCT03487432)
- Testing
- Super High-Pressure NC PTCA Balloon (OPN NC), Scoring PTCA Balloon (NSE Alpha)
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 74 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Artery Disease, Calcification
Rotablation vs Intravascular Lithotripsy in Calcified Coronary Lesions
Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of Intravascular Lithotripsy (IVL) compared to Rotational Atherectomy (RA) treatment in calcified coronary lesions
- Trial name
- DECALCIFY (NCT04960319)
- Testing
- Intravascular Lithotripsy
- Volunteers
- 100 people
- Sponsor
- Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Permanent Atrial Fibrillation, Venous Thrombosis
Vascular CalcIfiCation and sTiffness Induced by ORal antIcoAgulation
The VICTORIA Study (Vascular CalcIfiCation and sTiffness induced by ORal antIcoAgulation) is a comparative, parallel, prospective, controlled and randomized study of the structural and functional impact of rivaroxaban versus…
- Conditions
- Permanent Atrial Fibrillation, Venous Thrombosis, Pulmonary Embolism, Anticoagulation Treatment at Least > or = to 12-month
- Trial name
- VICTORIA (NCT02161965)
- Testing
- Rivaroxaban, Fluindione, Warfarin
- Where
- France
- Volunteers
- 51 people
- Sponsor
- University Hospital, Angers
Aortic Valve Disease, Aortic Valve Stenosis
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for…
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT02221921
- Testing
- MicroPort's Transcatheter Aortic Valve and Delivery System
- Where
- China
- Volunteers
- 89 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Aortic Stenosis, Gastrointestinal Microbiome
Involvement of the Gut Microbiota in Calcified Aortic Stenosis
Calcific aortic stenosis (CAS) is a disease characterized by progressive calcification of the aortic valve, obstructing the passage of blood from the left ventricle into the general circulation.
- Conditions
- Aortic Stenosis, Gastrointestinal Microbiome, Metabolomics
- Trial name
- Gut-CAS (NCT06021535)
- Testing
- No intervention
- Volunteers
- 100 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Coronary Artery Calcification
Toe-brachial Index and Coronary Calcification in Type 1 and 2 Diabetes
Diabetes is not a coronary risk equivalent, despite cardiovascular disease is the most common cause of death in diabetes. So, to identify diabetic patients at high cardiovascular risk is necessary.
- Trial name
- ACCoDiab (NCT03920683)
- Testing
- Data collection
- Where
- France
- Volunteers
- 707 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Coronary Artery Disease, Coronary Disease
Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled.
- Trial name
- OraBil (NCT06736899)
- Testing
- Orbital Atherectomy System Treatment, Balloon System Treatment
- Where
- 9 sites in Spain
- Volunteers
- 200 people
- Sponsor
- Fundación EPIC
Degenerative Heart Valve Disease, Heart Valve Calcification
Calcium-Phosphorus Regulation Therapy on Heart Valve Disease
The goal of this clinical trial is to learn if calcium-phosphorus regulation therapy can slow the progression of heart valve calcification in patients with degenerative heart valve disease and chronic kidney disease (CKD).
- Conditions
- Degenerative Heart Valve Disease, Heart Valve Calcification, Chronic Kidney Disease(CKD), Calcium-Phosphorus Metabolism Disorders
- Trial name
- NCT06660524
- Testing
- Sevelamer, Calcium carbonate
- Where
- China
- Volunteers
- 196 people
- Sponsor
- China National Center for Cardiovascular Diseases
Calcific Aortic Valve Disease, AORTIC VALVE DISEASES
Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression
Calcific aortic valve stenosis (CAVS) is a condition in which the aortic valve progressively narrows and stiffens due to calcium deposition, eventually impairing blood flow from the heart to the body.
- Conditions
- Calcific Aortic Valve Disease, AORTIC VALVE DISEASES, Aortic Valve Stenosis
- Trial name
- VERIFICATION (NCT07715279)
- Testing
- Vericiguat (BAY1021189)
- Where
- China
- Volunteers
- 238 people
- Sponsor
- West China Hospital
Coronary Artery Disease
Feasibility of Orbital Atherectomy System in Calcified Bifurcation Lesion
ORBID-OA is a single-center, observational study in 30 patients with stable coronary artery disease. The aim of the study is to analyze the outcomes of main vessel stenting on side branch in calcified bifurcation lesion and…
- Trial name
- ORBID-OA (NCT03058510)
- Testing
- Frequency domain optical coherence tomography
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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
End-Stage Renal Disease, Hemodialysis
Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry
The high rate of cardiovascular complications in the dialysis population cannot be explained by traditional cardiovascular risk factors.
- Trial name
- NCT00297219
- Testing
- Low dialysate calcium, high dialysate calcium
- Where
- 3 sites in United States, Turkey (Türkiye)
- Volunteers
- 457 people
- Sponsor
- Ege University
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
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.
Coronary Arterial Disease, Calcified Coronary Artery Disease
ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions
Coronary artery disease is caused by narrowing of the artery lumen. Treatment with Percutaneous Coronary Intervention (PCI) may be needed.
- Trial name
- IVL (NCT07407738)
- Testing
- Shockwave IVL, Shockfast IVL
- Where
- 13 sites in France, Germany and 2 more
- Volunteers
- 120 people
- Sponsor
- Shunmei Medical