RECRUITING

RevCore for In Stent Thrombosis

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Conditions

In-stent Thrombosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

RevCore for In Stent Thrombosis (REVIT)

Quick Facts

Study Start:2024-09-09
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06394739

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years
  2. 2. Patients with stent age \> 6 weeks
  3. 3. Location of thrombosed stents in proximal lower extremity deep vein segments including at least common femoral, external iliac, or common iliac vein
  4. 4. RevCore Thrombectomy Catheter must enter vasculature
  5. 5. Willing and able to provide informed consent
  1. 1. Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel
  2. 2. Stents not wall apposed
  3. 3. Stents compressed to \<10mm
  4. 4. Bilateral in-stent thrombosis
  5. 5. Congenital anatomic anomalies of the iliac veins
  6. 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. 7. Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
  8. 8. Chronic non-ambulatory status
  9. 9. Known hypercoagulable states (e.g. antiphospholipid syndrome) that, in the opinion of the Investigator, cannot be medically managed throughout the study period
  10. 10. Inability to secure venous access
  11. 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. 12. Current participation in another investigational drug or device treatment study

Contacts and Locations

Study Contact

Jenifer Foss
CONTACT
(978)-587-6598
jenifer.foss@inarimedical.com

Study Locations (Sites)

Yale University
New Haven, Connecticut, 06511
United States
Medstar Health Research Institute
Washington, District of Columbia, 20010
United States
Mission Health Hospital
Asheville, North Carolina, 28801
United States
UH Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, 15212
United States
El Paso Cardiology Associates
El Paso, Texas, 79902
United States

Collaborators and Investigators

Sponsor: Inari Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-09
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-09-09
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • In-stent Thrombosis