Deep Vein ThrombosisNCT06871683
ClotTriever® Thrombectomy System Use-Result Survey in Japan
An observational study of Deep Vein Thrombosis, run by Inari Medical at 15 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- ClotTriever® Thrombectomy System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 15 sitesJapan
- Study dates
- 17 Feb 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
This is an all-comers survey of all patients treated with ClotTriever® Thrombectomy System in Japan.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Japan15 sites
Asahikawa Medical Hospital
Asahikawa, 078-8510
Asahi General Hospital
Chiba, 289-2511
Chiba University Hospital
Chuo, Chiba, 260-8677
Nozaki Tokushukai Hospital
Daitō, 574-0074
Shonan Kamakura
Kanagawa, 247-8533
St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511
Kyoto Katsura Hospital
Kyoto, 615-8256
Nara City Hospital
Nara, 630-8305
Osaka Police Hospital
Osaka, 543-0042
Ota Memorial Hospital
Ōta, Gunma, 373-8585
National Cerebral and Cardiovascular Center
Suita, Osaka, 564-8565
Mitsui Memorial Hospital
Tokyo, 101-8643
Keio University
Tokyo, 160-8582
Teikyo University
Tokyo, 173-8606
Mie University
Tsu, 514-0102
About this study
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.
- Conditions
- Deep Vein Thrombosis
- Being tested
- ClotTriever® Thrombectomy System
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClotTriever® Thrombectomy SystemDevice
ClotTriever® Thrombectomy System use for treatment of patients with deep vein thrombosis with acute severe symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Full Analysis Population | All subjects who the survey device entered their vasculature. Receives: Device: ClotTriever® Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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.
Measured: During the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start17 Feb 2025
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inari Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vorpal Technologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871683
- Sponsor's protocol ID
- 24-001
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ClotTriever® Thrombectomy System Use-Result Survey in Japan
- ClinicalTrials.gov ID
- NCT06871683
- Acronym / sponsor ID
- 24-001
- Conditions
- Deep Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Inari MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Vorpal Technologies
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full Analysis Population | – | Device: ClotTriever® Thrombectomy SystemAll subjects who the survey device entered their vasculature. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClotTriever® Thrombectomy SystemClotTriever® Thrombectomy System use for treatment of patients with deep vein thrombosis with acute severe symptoms. | Device | Full Analysis Population |
Primary outcome
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].
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
Related trials for Deep Vein Thrombosis
Not yet recruiting
SAFELY RULING OUT DEEP VEIN THROMBOSIS IN PREGNANCY WITH THE LEFt SCORE AND TRIMESTER-ADJUSTED D-DIMER CUTOFFS (the PREG-DVT Study): A PROSPECTIVE COHORT STUDY.
Pregnancy Related, Deep Vein Thrombosis
RecruitingObservational study
Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
Deep Vein Thrombosis (DVT), Thrombus in the Peripheral Venous Vasculature
Enrolling by invitation
Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines
Deep Vein Thrombosis
Recruiting
PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis
Deep Vein Thrombosis
RecruitingObservational study
TRiP-cast Score Validation and Evaluation of Adherence to Preventive Anticoagulant Treatment in Patients With Lower Limb Trauma Requiring Immobilization
Lower Extremity Injuries, Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis, run by Inari Medical at 15 sites in Japan.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major Adverse Events (time frame: Through 30 days post index procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.