RevCore for In Stent Thrombosis
ConditionIn-stent Thrombosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInari Medical
About this trial
The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Up to 100 subjects with in-stent thrombosis will be enrolled. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be eligible to participate in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Thrombectomy
DeviceRevCore Thrombectomy to treat in-stent thrombosis
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Evidence of successful stent recanalization
Defined as patency ≥50% luminal diameter utilizing intravascular ultrasound (IVUS)
Time frame
Immediately after the RevCore thrombectomy procedure for in-stent thrombosisSponsors and contacts
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Source ClinicalTrials.gov