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NCT05409989 · ClinicalTrials.gov registry record · NA

MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study

A NA study of Intracranial Aneurysm, sponsored by Microvention-Terumo.

Active
Registry status
NA
Development phase
154
Enrollment target
20
Study locations

NCT05409989 is a NA study of Intracranial Aneurysm that is active but no longer recruiting, run by Microvention-Terumo. The registered enrollment target is 154 participants, below the 9,185-participant average among 14 other Intracranial Aneurysm trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT05409989, a NA study of Intracranial Aneurysm, is active but no longer recruiting, sponsored by Microvention-Terumo.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
154 participants
Enrollment target
20
Study locations

Study Summary

The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study.

Conditions Studied

Intracranial Aneurysm

Interventions

  • DEVICE FRED™ X™

Study Locations (20)

New York

  • Albany Medical Center - Albany
  • University at Buffalo - Buffalo
  • Northwell Health - Manhasset
  • Mount Sinai - New York
  • Stony Brook University - Stony Brook
  • Montefiore Medical Center - The Bronx

Florida

  • Memorial Healthcare Systems - Hollywood
  • Orlando Health - Orlando

Kentucky

  • Baptist Healthcare System - Louisville
  • Norton Healthcare - Louisville

Massachusetts

  • Massachusetts General Brigham Incorporated - Boston
  • UMass Memorial Health - Worcester

Ohio

  • Ohio State University - Columbus
  • ProMedica Toledo Hospital - Toledo

Hawaii

  • Queen's Medical Center - Honolulu

Iowa

  • University of Iowa - Iowa City

Kansas

  • University of Kansas - Kansas City

Trial Details

FieldValue
Enrollment Target 154 participants
Start Date 2022-09-20
Est. Completion 2029-11
Phase NA

Sponsor

Microvention-Terumo

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05409989

The ClinicalTrials.gov registry entry for NCT05409989 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 9,185-participant average among 14 other Intracranial Aneurysm trials with a reported enrollment target (98% lower). The listed sponsor is Microvention-Terumo, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Intracranial Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which FRED™ X™ is the first listed.

NCT05409989 reports 20 study locations spanning 11 distinct geographic areas - top geographies include New York, Florida, Kentucky.

Frequently Asked Questions

What is clinical trial NCT05409989 about?

NCT05409989 is a clinical study titled "MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study". The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device b...

What is the current status of trial NCT05409989?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 154 participants. The study started on 2022-09-20. Estimated completion is 2029-11.

What conditions does trial NCT05409989 study?

This clinical trial studies the following conditions: Intracranial Aneurysm.

What interventions are being tested in trial NCT05409989?

The interventions under investigation include: FRED™ X™ (DEVICE).

Who is sponsoring clinical trial NCT05409989?

This trial is sponsored by Microvention-Terumo, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05409989 being conducted?

This trial has 20 study locations across Florida, Hawaii, Iowa, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.