Clinical Impact of Calcified Nodule in Patients with Heavily Calcified Lesions Requiring Rotational Atherectomy

Not Applicable

• Conditions: Coronary artery disease

• Registration Number: JPRN-UMIN000038983
• Lead Sponsor: Kokura Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-25
• Study Completion: 2020-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Cardiac arrest or cardiogenic shock at the index PCI (2) Stent implantation except for second-generation drug-eluting stent (3) A case that IVUS data was unanalyzable

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint was the cumulative 5-year incidence of major adverse cardiac events (MACE), defined as a composite of cardiac death,clinically driven target lesion revascularization, stent thrombosis. We sought to compare 5-year MACE between calcified nodule (CN) and non-CN groups.

Secondary Outcome Measures

Name	Time	Method
(1) The prevalence of calcified nodule in lesions with heavily calcified lesions requiring rotational atherectomy. (2) Assessment of IVUS findings when in-stent restenosis occurred after stent implantation in lesions with calcified nodule.