Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062465) titled 'A Prospective Observational Study on the Association Between Extracellular Volume (ECV) Fraction and Aneurysm Sac Enlargement Using Photon-Counting CT in Patients After Endovascular Aneurysm Repair for Abdominal Aortic Aneurysm' on Oct. 1.
Study Type:
Observational
Primary Sponsor:
Institute - WAKAYAMA MEDICAL UNIVERSITY
Condition:
Condition - Abdominal Aortic Aneurysm
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate whether the extracellular volume (ECV) fraction of the aneurysm wall can predict future aneurysm sac enlargement after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA).
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - - Adult patients aged 20 years or older
- Patients whose renal function meets the criteria for contrast-enhanced CT examination
- Patients scheduled for routine contrast-enhanced CT between 1 month and 12 months after EVAR
- Patients who can provide written informed consent to participate in this study
Key exclusion criteria - - Patients with active infection
- Patients with inflammatory or dissecting aortic aneurysms
- Patients with connective tissue disease
- Patients who underwent emergency EVAR
- Cases of isolated iliac artery aneurysm
- Cases where consent is withdrawn by the patient at enrollment or during the follow-up period
- Cases with missing clinical laboratory data required for evaluation (e.g., hematocrit value) or long-term aneurysm diameter follow-up data
- Cases where accurate measurement or analysis of aneurysm wall ECV is impossible due to excessive motion artifacts, metallic artifacts, or other factors on imaging
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 03 Day
Date of IRB - 2026 Year 09 Month 24 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071468
Disclaimer: Curated by HT Syndication.