Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062510) titled 'Embolization of Persistent Endoleaks after EVAR with High Concentration Glucose Solution: A Pilot Study' on Oct. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Other

Condition: Condition - Abdominal Aortic Aneurysm Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Pilot Study on the Safety of High Concentration Glucose Solution Embolization for Type II Endoleaks after EVAR Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Embolization of Endoleaks after EVAR with High Concentration Glucose Solution

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - 1)Written informed consent obtained from the patient or legal guardian. 2)Expected survival of at least 18 months from the date of enrollment. 3)Prior EVAR for abdominal aortic aneurysm, with dynamic CT or MRI demonstrating contrast enhancement within the aneurysm sac suggestive of an endoleak. 4)Aneurysm sac enlargement, even if contrast enhancement is not clearly observed. 5)Suspected Type 2 or Type 5 endoleak. 6)Open surgical repair is contraindicated or the patient refuses open surgery. 7)Preserved major organ function, defined as: 1. WBC over 2500/mm3 2. Platelets over 50000/mm3 3. Hemoglobin over 6.0 g/dL 4. Serum creatinine less than 3.0 mg/dL 5. Total bilirubin less than 3.0 mg/dL Key exclusion criteria - 1)Age over 90 years. 2)Presence of severe comorbidities, including: 1. Uncontrolled malignancy 2. Severe pulmonary disease 3. Severe cardiac disease 4. Severe hepatic or renal dysfunction 5. Severe active inflammation or infection 6. Poorly controlled diabetes mellitus 7. Immunosuppressed state such as ongoing steroid therapy 8. Any other condition judged by the investigator to significantly interfere with study procedures 3)Inability to maintain prone or lateral decubitus position. 4)Inability to undergo MRI examination. 5)Inability to safely puncture the abdominal aortic aneurysm sac. 6)Clinically significant bleeding tendency (PT INR over 2.0). 7)Ongoing use of antiplatelet, thrombolytic, or anticoagulant agents that cannot be temporarily discontinued. 8)Patients undergoing dialysis. 9)Type 1,3,4 endoleaks. Because these types may be diagnosed only after angiography performed post registration, exclusion after enrollment is permitted. Excluded cases will not be counted toward the total enrollment number. 10)Pregnancy or possibility of pregnancy. 11)Determination by the attending physician that the patient is unsuitable for participation in this study. Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 07 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2026 Year 10 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071547

Disclaimer: Curated by HT Syndication.