NCT06394739

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
23mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Sep 2024Apr 2028

First Submitted

Initial submission to the registry

April 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 9, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

April 26, 2024

Last Update Submit

March 25, 2026

Conditions

In-stent Thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

ThrombectomyDEVICE

RevCore Thrombectomy to treat in-stent thrombosis

Also known as: RevCore Thrombectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Yale University

New Haven, Connecticut, 06511, United States

RECRUITING

Medstar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

New York University- Langone

New York, New York, 10016, United States

RECRUITING

Mission Health

Asheville, North Carolina, 28801, United States

RECRUITING

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Ohio State University

Columbus, Ohio, 23210, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

WITHDRAWN

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

RECRUITING

El Paso Cardiology Associates

El Paso, Texas, 79902, United States

RECRUITING

Sentara

Norfolk, Virginia, 23507, United States

RECRUITING

University of Washington

Seattle, Washington, 98133, United States

RECRUITING

West Virginia University- Ruby Memorial

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Interventions

Thrombectomy

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Jenifer Foss

CONTACT

(978)-587-6598jenifer.foss@stryker.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2024

First Posted

May 1, 2024

Study Start

September 9, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

US(15)