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RECRUITING
NCT05800002
NA

IVUS-guided DES Implantation in Coronary Calcification

Sponsor: Nanjing First Hospital, Nanjing Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: Intravascular Ultrasound Versus Angiography Guided Drug-eluting Stent Implantation for Patients With Coronary Severe Calcification: a Prospective, Multicenter, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

864

Start Date

2023-04-07

Completion Date

2033-03-30

Last Updated

2024-11-15

Healthy Volunteers

No

Interventions

PROCEDURE

Intravascular ultrasound

Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on intravascular ultrasound.

PROCEDURE

Angiography

Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on angiography.

Locations (1)

Nanjing First Hospital

Nanjing, Jiangsu, China