Peripheral RotablatorPRO Post-Marketing Database Study

Peripheral RotablatorPRO Post-Marketing Database Study - Peripheral RotablatorPRO Post-Marketing Database Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060755

Enrollment

Registered

2026-03-02

Start date

2026-04-20

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic limb-threatening ischemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients intended to be treated with Peripheral RotablatorPRO

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
The incidence of adverse events related to the use of the device and angiographic events, including vascular dissection, vessel perforation, and distal embolization, will be evaluated. In addition, the incidence of device malfunction events, including guidewire fracture, retained guidewire, difficulty in guidewire removal, and difficulty in burr removal, will be evaluated.	—

Countries

Japan

Contacts

Public ContactHiroshi Sakamoto

Boston Scientific Japan K.K. Clinical Affairs

Hiroshi.Sakamoto@bsci.com03-6853-7500

Outcome results