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In-stent ThrombosisREVITNCT06394739

RevCore for In Stent Thrombosis

An observational study of In-stent Thrombosis, run by Inari Medical at 17 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
In-stent Thrombosis
What is being tested?
Thrombectomy
Type of treatment
Medical device
How many people
100 participants
Where
17 sitesUnited States
Study dates
9 Sep 2024to Apr 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jenifer Foss contact

(978)-587-6598

jenifer.foss@stryker.com

17 sites in 1 country

United States17 sites, 16 recruiting

  • Mission Health

    Asheville, North Carolina, 28801

    Trevor Downing, MD

    Trevor Downing, MD

    Recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Brajesh Lal, MD

    Brajesh Lal, MD

    Recruiting

  • St. Luke's Hospital Boise

    Boise, Idaho, 83712

    Tyler Harris, MD

    Tyler Harris, MD

    Recruiting

  • UH Cleveland Medical Center

    Cleveland, Ohio, 44106

    Karem Harth, MD

    Karem Harth, MD

    Recruiting

  • Ohio State University

    Columbus, Ohio, 23210

    Mina Makary, MD

    Mina Makary, MD

    Recruiting

  • El Paso Cardiology Associates

    El Paso, Texas, 79902

    Waseem Shami, MD

    Waseem Shami, MD

    Recruiting

  • West Virginia University- Ruby Memorial

    Morgantown, West Virginia, 26506

    Robert Grammer, MD

    Robert Grammer, MD

    Recruiting

  • Yale University

    New Haven, Connecticut, 06511

    Angelo Marino, OD

    Angelo Marino, OD

    Recruiting

  • New York University- Langone

    New York, New York, 10016

    Mikel Sadek, MD

    Mikel Sadek, MD

    Recruiting

  • Sentara

    Norfolk, Virginia, 23507

    David Dexter, MD

    David Dexter, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Ryan Cobb, MD

    Ryan Cobb, MD

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Withdrawn

  • Allegheny Health Network Research Institute

    Pittsburgh, Pennsylvania, 15212

    Abdullah Shaikh, MD

    Abdullah Shaikh, MD

    Recruiting

  • Baylor Scott & White Research Institute

    Plano, Texas, 75093

    Joseph Liechty, MD

    Recruiting

  • University of Washington

    Seattle, Washington, 98133

    Jake Hemingway, MD

    Jake Hemingway, MD

    Recruiting

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

    Brian Brown, MD

    Brian Brown, MD

    Recruiting

  • Medstar Health Research Institute

    Washington D.C., District of Columbia, 20010

    Kyle Reynolds, MD

    Steven Abramowitz

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Thrombectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThrombectomyDevice

    Also called RevCore Thrombectomy

    RevCore Thrombectomy to treat in-stent thrombosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evidence of successful stent recanalization

    Defined as patency ≥50% luminal diameter utilizing intravascular ultrasound (IVUS)

    Measured: Immediately after the RevCore thrombectomy procedure for in-stent thrombosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2024
  2. Study start9 Sep 2024
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06394739
Sponsor's protocol ID
23-002 REVIT
Acronym
REVIT
Status last verified
Oct 2026
First submitted
26 Apr 2024
Last updated
27 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of In-stent Thrombosis, run by Inari Medical at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jenifer Foss ((978)-587-6598, jenifer.foss@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evidence of successful stent recanalization (time frame: Immediately after the RevCore thrombectomy procedure for in-stent thrombosis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06394739.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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