Tokyo, March 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060755) titled 'Peripheral RotablatorPRO Post-Marketing Database Study' on March 2.
Study Type:
Observational
Primary Sponsor:
Institute - Boston Scientific Japan K.K.
Condition:
Condition - Chronic limb-threatening ischemia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To detect or confirm the occurrence rate of each type of device deficiencies as well as the information on quality, safety and efficacy under the clinical practice
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients intended to be treated with Peripheral RotablatorPRO
Key exclusion criteria - Not applicable
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 12 Day
Anticipated trial start date - 2026 Year 03 Month 03 Day
Last follow-up date - 2028 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069523
Disclaimer: Curated by HT Syndication.