RevCore for In Stent Thrombosis

Recruiting now

Conditions studied: In-stent Thrombosis

In brief

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

Key facts

Study ID

NCT06394739

Run by

Inari Medical

People needed

100

Starts

2024-09-09

Expected to finish

2028-04-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• West Virginia University- Ruby Memorial — Morgantown, West Virginia, United States (enrolling)
• Medstar Health Research Institute — Washington D.C., District of Columbia, United States (enrolling)
• St. Luke's Hospital Boise — Boise, Idaho, United States (enrolling)
• University of Maryland — Baltimore, Maryland, United States (enrolling)
• New York University- Langone — New York, New York, United States (enrolling)
• Mission Health — Asheville, North Carolina, United States (enrolling)
• UH Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Allegheny Health Network Research Institute — Pittsburgh, Pennsylvania, United States (enrolling)
• Spartanburg Medical Center — Spartanburg, South Carolina, United States (enrolling)
• El Paso Cardiology Associates — El Paso, Texas, United States (enrolling)
• Baylor Scott & White Research Institute — Plano, Texas, United States (enrolling)
• Sentara — Norfolk, Virginia, United States (enrolling)
• University of Washington — Seattle, Washington, United States (enrolling)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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