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RevCore for In Stent Thrombosis

RevCore for In Stent Thrombosis

Recruiting
18 years and older
All
Phase N/A

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Overview

The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.

Eligibility

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

Study details
    In-stent Thrombosis

NCT06394739

Inari Medical

18 August 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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