50
Participants
Start Date
March 31, 2025
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2026
Orbital atherectomy
The Diamondback-360 (OAS) (Abbott) device is used to perform this technique, consisting of a bidirectional, diamond-coated orbital crown that utilizes a combination of centrifugal force (creating elliptical orbits) and surface abrasion to modify the calcified plaque and increase distensibility. Additionally, the pulsatile impact of the crown at high speed can create microfractures in deep calcium. As a result, a single 1.25 mm crown can treat vessels ranging from 2.5 to 4 mm in diameter.
Intravascular lithotripsy
The Shockwave Medical Intravascular Lithotripsy System (Shockwave Medical) is a balloon that emits pulsatile sonic waves capable of fracturing intracoronary calcium. This therapy is administered by advancing a catheter and inflating the balloon at low pressure to deliver sonic pulses.
Optical Coherence Tomography (OCT)
"Optical Coherence Tomography (OCT) is an intravascular imaging modality that uses near-infrared light to provide high-definition, cross-sectional and three-dimensional images of the vessel microstructure.~These images provide additional information on the degree and characteristics of coronary artery disease compared to angiography which doesn't delineate the composition of the coronary artery. With automated, highly accurate measurements, OCT can guide stent selection, placement, and deployment."
Percutaneous coronary intervention with stent implantation
All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.
Hospital Universitario Lucus Augusti, Lugo
Hospital Universitario Ramón y Cajal, Madrid
Hospital Universitario de Salamanca, Salamanca
Hospital Clínico Universitario de Valladolid, Valladolid
Hospital Universitario General de Alicante, Alicante
Collaborators (1)
Abbott
INDUSTRY
Spanish Society of Cardiology
OTHER