ClotTriever® Thrombectomy System Use-Result Survey in Japan

August 25, 2026 updated by: Inari Medical

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Asahikawa, Japan, 078-8510
        • Asahikawa Medical Hospital
      • Chiba, Japan, 289-2511
        • Asahi General Hospital
      • Daitō, Japan, 574-0074
        • Nozaki Tokushukai Hospital
      • Kanagawa, Japan, 247-8533
        • Shonan Kamakura
      • Kyoto, Japan, 615-8256
        • Kyoto Katsura Hospital
      • Nara, Japan, 630-8305
        • Nara City Hospital
      • Osaka, Japan, 543-0042
        • Osaka Police Hospital
      • Tokyo, Japan, 173-8606
        • Teikyo University
      • Tokyo, Japan, 101-8643
        • Mitsui Memorial Hospital
      • Tokyo, Japan, 160-8582
        • Keio University
      • Tsu, Japan, 514-0102
        • Mie University
    • Chiba
      • Chuo, Chiba, Japan, 260-8677
        • Chiba University Hospital
    • Gunma
      • Ōta, Gunma, Japan, 373-8585
        • Ota Memorial Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna University Hospital
    • Osaka
      • Suita, Osaka, Japan, 564-8565
        • National cerebral and cardiovascular center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with deep vein thrombosis with acute severe symptoms (excluding postthrombotic syndrome) for whom the ClotTriever® Thrombectomy System was used. Patients will be enrolled until at least 100 subjects complete the follow-up period through 6 months.

Description

This is an all-comers survey of all patients treated with ClotTriever® Thrombectomy System in Japan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Full Analysis Population
All subjects who the survey device entered their vasculature.
Device: ClotTriever® Thrombectomy System
ClotTriever® Thrombectomy System use for treatment of patients with deep vein thrombosis with acute severe symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Major Adverse Events
Time Frame: 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].
Through 30 days post index procedure.
Technical Success
Time Frame: 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.
During the index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inari Medical

Collaborators

Vorpal Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 12, 2025

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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