IVUS-guided DES Implantation in Coronary Calcification

Coronary calcified lesion is associated with a poor clinical outcome. Intravascular ultrasound (IVUS) provides anatomic information in detail about reference vessel dimensions and lesion characteristics including severity of diameter stenosis, lesion length, and morphology. Both randomized and observational studies have reported the clinical benefits of IVUS guidance for patients with chronic total occlusion (CTO), long lesions, acute coronary syndrome (ACS) with complex bifurcation lesions. Our previous ULTIMATE trial has demonstrated that IVUS-guided drug-eluting stent (DES) implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance. However, the benefit of IVUS guidance in coronary severe calcification still remains unknown in the modern DES era.

NCT Number	NCT05800002
Lead Sponsor	Nanjing First Hospital, Nanjing Medical University
Conditions	Coronary Artery Disease
Enrollment	864 participants
Start Date	2023-04-07
Primary Completion	2026-03-30 (estimated)
Study Completion	2033-03-30 (estimated)
Updated on ClinicalTrials.gov	2024-11-15