RevCore for In Stent Thrombosis (REVIT)

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: Recruiting
• Conditions: In-stent Thrombosis
• Intervention / Treatment: Device: Thrombectomy

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jenifer Foss; Phone Number: (978)-587-6598; Email: jenifer.foss@stryker.com

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      • Withdrawn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
  • 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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of successful stent recanalization	Defined as patency ≥50% luminal diameter utilizing intravascular ultrasound (IVUS)	Immediately after the RevCore thrombectomy procedure for in-stent thrombosis

Collaborators and Investigators

• Sponsor: Inari Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Surgical Procedures, Operative; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Thrombectomy
• Other Study ID 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