Calcium Reduction by Orbital Atherectomy in Western Europe

UnknownOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

March 15, 2024

Primary Completion Date

April 1, 2025

Study Completion Date

April 1, 2025

Conditions
Vascular Calcification* / Diagnostic ImagingAtherectomies, CoronaryTomography, Optical CoherenceCoronary Intervention, PercutaneousCoronary AngiographyHumansTreatment OutcomeVascular Calcification* / TherapyVascular Calcification
Interventions
DEVICE

Orbital Atherectomy

The Diamondback 360° Coronary orbital atherectomy system (OAS) is a device dedicated to debulk severely calcified coronary lesions to facilitate stent delivery and enable stent expansion with optimal results. The OAS's main mechanism is the synergistic rotation of the crown around its axis and simultaneously its endoluminal orbital motion. This effect allows blood to flow continuously and it facilitates heat dispersion which results in reduced heat damage to the arterial walls and subsequently to less myocardial damage, at the same time it softens the plaques tissue. It also appears that the microparticles created from sanding the artery plaques do not create any agglomeration to the branching arteries

Trial Locations (1)

3015GE

RECRUITING

Erasmus Medical Center, Rotterdam

Sponsors
All Listed Sponsors
lead

Erasmus Medical Center

OTHER