RevCore for In Stent Thrombosis (REVIT)

August 7, 2026 updated by: Inari Medical

RevCore for In Stent Thrombosis (REVIT)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale University
        • Contact:
          • Angelo Marino, OD
        • Principal Investigator:
          • Angelo Marino, OD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Health Research Institute
        • Principal Investigator:
          • Kyle Reynolds, MD
        • Sub-Investigator:
          • Steven Abramowitz
        • Contact:
          • Kyle Reynolds, MD
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • St. Luke's Hospital Boise
        • Contact:
          • Tyler Harris, MD
        • Principal Investigator:
          • Tyler Harris, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Principal Investigator:
          • Khanjan Nagarsheth, MD
        • Contact:
          • Khanjan Nagarsheth, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • New York University- Langone
        • Principal Investigator:
          • Mikel Sadek, MD
        • Contact:
          • Mikel Sadek, MD
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Recruiting
        • Mission Health
        • Principal Investigator:
          • Trevor Downing, MD
        • Contact:
          • Trevor Downing, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • UH Cleveland Medical Center
        • Principal Investigator:
          • Karem Harth, MD
        • Contact:
          • Karem Harth, MD
      • Columbus, Ohio, United States, 23210
        • Recruiting
        • Ohio State University
        • Principal Investigator:
          • Mina Makary, MD
        • Contact:
          • Mina Makary, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
          • Ryan Cobb, MD
        • Principal Investigator:
          • Ryan Cobb, MD
      • Philadelphia, Pennsylvania, United States, 19107
        • Withdrawn
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network Research Institute
        • Contact:
          • Abdullah Shaikh, MD
        • Principal Investigator:
          • Abdullah Shaikh, MD
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Principal Investigator:
          • Brian Brown, MD
        • Contact:
          • Brian Brown, MD
    • Texas
      • El Paso, Texas, United States, 79902
        • Recruiting
        • El Paso Cardiology Associates
        • Contact:
          • Waseem Shami, MD
        • Principal Investigator:
          • Waseem Shami, MD
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White Research Institute
        • Contact:
          • Joseph Liechty, MD
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara
        • Principal Investigator:
          • David Dexter, MD
        • Contact:
          • David Dexter, MD
    • Washington
      • Seattle, Washington, United States, 98133
        • Recruiting
        • University of Washington
        • Contact:
          • Jake Hemingway, MD
        • Principal Investigator:
          • Jake Hemingway, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University- Ruby Memorial
        • Contact:
          • Robert Grammer, MD
        • Principal Investigator:
          • Robert Grammer, MD

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Up to 100 subjects with in-stent thrombosis will be enrolled. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be eligible to participate in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evidence of successful stent recanalization
Time Frame: Immediately after the RevCore thrombectomy procedure for in-stent thrombosis
Defined as patency ≥50% luminal diameter utilizing intravascular ultrasound (IVUS)
Immediately after the RevCore thrombectomy procedure for in-stent thrombosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-002 REVIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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