RecruitingNot Applicable

RevCore for In Stent Thrombosis

United States100 participantsStarted 2024-09-09

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years
✓. Patients with stent age \> 6 weeks
✓. Location of thrombosed stents in proximal lower extremity deep vein segments including at least common femoral, external iliac, or common iliac vein
✓. RevCore Thrombectomy Catheter must enter vasculature
✓. Willing and able to provide informed consent

✕. Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel
✕. Stents not wall apposed
✕. Stents compressed to \<10mm
✕. Bilateral in-stent thrombosis
✕. Congenital anatomic anomalies of the iliac veins
✕. Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used
✕. Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
✕. Chronic non-ambulatory status

Evidence of successful stent recanalization

Timeframe: Immediately after the RevCore thrombectomy procedure for in-stent thrombosis

NCT IDNCT06394739

SponsorInari Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-04

Jenifer Foss