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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038983

Enrollment

264

Registered

2019-12-25

Start date

2019-12-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Angiographic or IVUS findings showed heavily calcified lesions requiring rotational atherectomy between Jan 2011 and February 2014 (2) Second-generation drug-eluting stent was implanted (3) PCI was performed with IVUS guidance

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
(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.	—

Countries

Japan

Contacts

Public ContactShoichi Kuramitsu

Kokura Memorial Hospital Cardiology

kuramitsu@circulation.jp0935112000

Outcome results