NCT07105930View on ClinicalTrials.gov

Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach

NANot yet recruitingINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

March 31, 2027

Conditions
Orbital Atherectomy
Interventions
DEVICE

Debulging approach using the orbital atherectomy system

A uniform approach using only the orbital atherectomy system (Diamondback 360®), which sands away the calcium with a rotating crown

PROCEDURE

Debulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapy

A tailored approach, where the operator chooses from various available methods based on the patient's specific type of calcium

All Listed Sponsors
lead

IHF GmbH - Institut für Herzinfarktforschung

OTHER

NCT07105930 - Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach | Biotech Hunter | Biotech Hunter