Clinical Trial: A multicenter, prospective registry study on the efficacy and safety of mechanical thrombectomy using pRESET and Esperance for acute cerebral artery occlusion (Japan)

Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062504) titled 'A multicenter, prospective registry study on the efficacy and safety of mechanical thrombectomy using pRESET and Esperance for acute cerebral artery occlusion' on Aug. 7.

Study Type: Observational

Primary Sponsor: Institute - Hyogo Medical University

Condition: Condition - (acute ischemic stroke) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To prospectively evaluate, in a multicenter real-world setting, the efficacy (e.g., successful reperfusion defined as mTICI 2b or higher) and safety of mechanical thrombectomy using pRESET and/or Esperance as first-line devices in patients with acute cerebral artery occlusion, by first-line treatment strategy (combined use / Esperance alone) and by occlusion site. Exploratory objectives include describing procedural strategy transitions after an unsuccessful first pass and the association between procedural step times and outcomes. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria: (1) Aged 20 years or older. (2) Patients who underwent acute recanalization therapy (mechanical thrombectomy) for cerebral artery occlusion in which pRESET/pRESET Delta or Esperance 3+/5F/6F/pHLO was used as the first-line (first-pass) device; specifically, the first pass was performed with Esperance 3+/5F/6F/pHLO alone, or with the combination of pRESET/pRESET Delta and Esperance 3+/5F/6F/pHLO (first-line use of pRESET alone or of other thrombectomy devices is not eligible; PTA balloons are not regarded as thrombectomy devices, and patients in whom pRESET or Esperance was used after PTA are eligible). (3) Written informed consent obtained from the patient or a legally acceptable representative. (4) Patients expected to be evaluable throughout the 90-day observation period after the procedure. Key exclusion criteria - Patients who meet any of the following criteria are excluded: (1) Patients in whom a medical device not approved in Japan was used. (2) Patients judged by the site principal investigator to be unsuitable for participation due to serious comorbidities or other reasons. Target Size - 1250

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 28 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2028 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071548

Disclaimer: Curated by HT Syndication.