Recruiting NCT06394739
RevCore for In Stent Thrombosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thrombectomy.
- Who it may be relevant to
- Registry conditions: In-stent Thrombosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
RevCore for In Stent Thrombosis (REVIT)
Overview
The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.
Interventions
- Device Thrombectomy
RevCore Thrombectomy to treat in-stent thrombosis
Primary outcome measures
- Evidence of successful stent recanalization [Time frame: Immediately after the RevCore thrombectomy procedure for in-stent thrombosis]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 17 centers
- Yale University — New Haven
- Medstar Health Research Institute — Washington D.C.
- St. Luke's Hospital Boise — Boise
- University of Maryland — Baltimore
- New York University- Langone — New York
- Mission Health — Asheville
- UH Cleveland Medical Center — Cleveland
- Ohio State University — Columbus
- … and 9 more centers
Identifiers
NCT: NCT06394739 · 23-002 REVIT