RevCore for In Stent Thrombosis

RevCore for In Stent Thrombosis (REVIT)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06394739

Acronym

REVIT

Enrollment

100

Registered

2024-05-01

Start date

2024-09-09

Completion date

2028-04-01

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In-stent Thrombosis

Brief summary

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

Interventions

DEVICEThrombectomy

RevCore Thrombectomy to treat in-stent thrombosis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evidence of successful stent recanalization	Immediately after the RevCore thrombectomy procedure for in-stent thrombosis	Defined as patency ≥50% luminal diameter utilizing intravascular ultrasound (IVUS)

Countries

United States

Contacts

CONTACTJenifer Foss

jenifer.foss@stryker.com(978)-587-6598

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026