ClotTriever® Thrombectomy System Use-Result Survey in Japan
1 other identifier
observational
100
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2025
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 17, 2025
CompletedFirst Submitted
Initial submission to the registry
March 6, 2025
CompletedFirst Posted
Study publicly available on registry
March 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
May 4, 2026
April 1, 2026
3 years
March 6, 2025
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of Major Adverse Events
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
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
Study Arms (1)
Full Analysis Population
All subjects who the survey device entered their vasculature.
Interventions
ClotTriever® Thrombectomy System use for treatment of patients with deep vein thrombosis with acute severe symptoms.
Eligibility Criteria
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.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Inari Medicallead
- Vorpal Technologiescollaborator
Study Sites (13)
Chiba University Hospital
Chūō, Chiba, 260-8677, Japan
Ota Memorial Hospital
Ōta, Gunma, 373-8585, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511, Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, 564-8565, Japan
Asahikawa Medical Hospital
Asahikawa, 078-8510, Japan
Asahi General Hospital
Chiba, 289-2511, Japan
Nozaki Tokushukai Hospital
Daitō, 574-0074, Japan
Shonan Kamakura
Kanagawa, 247-8533, Japan
Kyoto Katsura Hospital
Kyoto, 615-8256, Japan
Nara City Hospital
Nara, 630-8305, Japan
Osaka Police Hospital
Osaka, 543-0042, Japan
Mitsui Memorial Hospital
Tokyo, 101-8643, Japan
Mie University
Tsu, 514-0102, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2025
First Posted
March 12, 2025
Study Start
February 17, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
May 4, 2026
Record last verified: 2026-04