Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Coronary Arterial Disease (CAD)Coronary CalcificationCoronary Calcified NodulesOrbital AtherectomyIntravascular LithotripsyOptical Coherence Tomography (OCT)Percutaneous Coronary Intervention (PCI)Chronic Coronary SyndromeAcute Coronary Syndrome (ACS)
Interventions
DEVICE

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.

DEVICE

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.

DEVICE

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."

DEVICE

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.

Trial Locations (5)

27003

Hospital Universitario Lucus Augusti, Lugo

28034

Hospital Universitario Ramón y Cajal, Madrid

37007

Hospital Universitario de Salamanca, Salamanca

47003

Hospital Clínico Universitario de Valladolid, Valladolid

03010

Hospital Universitario General de Alicante, Alicante

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott

INDUSTRY

lead

Spanish Society of Cardiology

OTHER