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Clinical Trials/NCT06394739
NCT06394739
Recruiting
Not Applicable

RevCore for In Stent Thrombosis (REVIT)

Inari Medical28 sites in 1 country100 target enrollmentSeptember 9, 2024
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ConditionsIn-stent Thrombosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
In-stent Thrombosis
Sponsor
Inari Medical
Enrollment
100
Locations
28
Primary Endpoint
Evidence of successful stent recanalization
Status
Recruiting
Last Updated
2 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
September 9, 2024
End Date
April 1, 2028
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Sites (28)

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