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Using RevCore Catheter to Treat Stent Blockages

RevCore for In Stent Thrombosis (REVIT)

Observational Inari Medical · NCT06394739

This study is testing whether the RevCore Catheter can help people with blood clots in their stents in the legs feel better.

Quick facts

Study typeObservational
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorInari Medical Industry-sponsored
Locations16 sites (New Haven, Connecticut and 15 other locations)
Trial IDNCT06394739 on ClinicalTrials.gov

What this trial studies

This research aims to gather data on the effectiveness of the RevCore Thrombectomy Catheter in treating in-stent thrombosis, which occurs when blood clots form within stents. The study will observe patients who have experienced stent blockages in specific deep vein segments of the lower extremities. Participants will be monitored to assess the catheter's performance and outcomes related to the treatment of these blockages. The study is observational, meaning it will collect data without altering the standard treatment protocols.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with thrombosed stents located in specific deep vein segments of the lower extremities.

Not a fit: Patients with severely damaged stents, bilateral in-stent thrombosis, or certain medical contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options for patients suffering from stent blockages, potentially leading to better outcomes and reduced complications.

How similar studies have performed: While this approach is being evaluated in this specific context, similar thrombectomy techniques have shown promise in treating vascular blockages in other studies.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

New Haven, Connecticut and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions In-stent Thrombosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.