ClotTriever® Thrombectomy System Use-Result Survey in Japan

• Conditions: Deep Vein Thrombosis

• Registration Number: NCT06871683
• Lead Sponsor: Inari Medical

Brief Summary

The objective of this survey is to determine the safety and efficacy of the ClotTriever Thrombectomy System under daily clinical practice after marketing approval in Japan.

This device was designated as a subject of use results evaluation at the time of application for manufacturing and marketing approval.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-17
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-06
• Study First Posted: 2025-03-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-16
• Primary Completion: 2028-03
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Major Adverse Events	Through 30 days post index procedure.	Rate of Major Adverse Events \[All-cause mortality, Major bleeding, New symptomatic Pulmonary Embolism (PE) documented by Computed Tomography Pulmonary Angiography (CTPA), Rethrombosis of a Target Venous Segment\].
Technical Success	During the index procedure	Thrombus residual volume assessed by the the treating physician using pre- and post-procedure venography to evaluate the success of thrombus removal.

Trial Locations

Locations (4)

St. Marianna University Hospital; 🇯🇵 Kawasaki, Kanagawa, Japan

Chiba University Hospital; 🇯🇵 Chuo, Chiba, Japan

Ota Memorial Hospital; 🇯🇵 Ota, Gunma, Japan

National Cerebral and Cardiovascular Center; 🇯🇵 Suita, Osaka, Japan