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Recruiting

NCT Number: NCT06394739

RevCore for In Stent Thrombosis

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

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Known hypercoagulable states (e.g. antiphospholipid syndrome) that, in the opinion of the Investigator, cannot be medically managed throughout the study period
  • Inability to secure venous access
  • Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
  • Current participation in another investigational drug or device treatment study

Treatment and study plan

Thrombectomy

Device

RevCore Thrombectomy to treat in-stent thrombosis

Other names: RevCore Thrombectomy

Primary outcomes

  1. Evidence of successful stent recanalization

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

    Defined as patency ≥50% luminal diameter utilizing intravascular ultrasound (IVUS)

Study contacts

Contact information is provided by the study sponsor or research team.

Jenifer Foss

CONTACT

[email protected]

(978)-587-6598

Sponsors and collaborators

Lead sponsor

Inari Medical

Industry

Registry information

Official study title

RevCore for In Stent Thrombosis (REVIT)

Acronym: REVIT

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 1, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.