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RevCore for In Stent Thrombosis

RecruitingN/A

Sponsor: Inari Medical

Conditions: In-stent Thrombosis

Interventions: Thrombectomy

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (17)

New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Boise, Idaho, United States
Baltimore, Maryland, United States
New York, New York, United States
Asheville, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Spartanburg, South Carolina, United States
El Paso, Texas, United States
Plano, Texas, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States