Tokyo, July 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062251) titled 'An observational study using optical coherence tomography to analyze the mechanisms of expansion in intravascular lithotripsy for calcified coronary artery lesions' on July 16.

Study Type: Observational

Primary Sponsor: Institute - Juntendo University

Condition: Condition - Coronary artery disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To elucidate the mechanism of vessel expansion following intravascular lithotripsy (IVL) in severely calcified coronary lesions, particularly those with calcified nodules Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients aged 20 years or older. 2. Patients who underwent percutaneous coronary intervention (PCI) using IVL for calcified coronary lesions. 3. Patients in whom optical coherence tomography (OCT) was used as the intravascular imaging modality during PCI. Key exclusion criteria - 1. Patients with acute myocardial infarction. 2. Patients with in-stent restenosis lesions. 3. Patients with chronic total occlusion lesions. 4. Patients who underwent balloon dilation with a balloon above 2.0 mm in diameter or debulking devices (rotational atherectomy or orbital atherectomy) before IVL. 5. Patients in whom a coronary stent was not implanted. 6. Patients with OCT images of insufficient quality for analysis. 7. Patients who are deemed inappropriate for inclusion in the study by the principal investigator. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 06 Day Date of IRB - 2026 Year 06 Month 03 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071231

Disclaimer: Curated by HT Syndication.