| NCT ID | NCT06394739 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inari Medical |
| Condition | In-stent Thrombosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-09-09 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Patients with stent age \> 6 weeks 3. Location of thrombosed stents in proximal lower extremity deep vein segments including at least common femoral, external iliac, or common iliac vein 4. RevCore Thrombectomy Catheter must enter vasculature 5. Willing and able to provide informed consent Exclusion Criteria: 1. Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel 2. Stents not wall apposed 3. Stents compressed to \<10mm 4. Bilateral in-stent thrombosis 5. Congenital anatomic anomalies of the iliac veins 6. Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used 7. Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period 8. Chronic non-ambulatory status 9. Known hypercoagulable states (e.g. antiphospholipid syndrome) that, in the opinion of the Investigator, cannot be medically managed throughout the study period 10. Inability to secure venous access 11. Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject 12. Current participation in another investigational drug or device treatment study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06394739 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying In-stent Thrombosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06394739 currently recruiting?
Yes, NCT06394739 is actively recruiting participants. Contact the research team at jenifer.foss@stryker.com for enrollment information.
Where is the NCT06394739 trial being conducted?
This trial is being conducted at New Haven, United States, Washington D.C., United States, Boise, United States, Baltimore, United States and 11 additional locations.
Who is sponsoring the NCT06394739 clinical trial?
NCT06394739 is sponsored by Inari Medical. The trial plans to enroll 100 participants.