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NCT04852783 · ClinicalTrials.gov registry record · Phase 4

US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair

A Phase 4 study of Aneurysm, Intracranial, sponsored by Cerus Endovascular.

Active
Registry status
Phase 4
Development phase
250
Enrollment target
20
Study locations

NCT04852783: Active Phase 4 study of Aneurysm, Intracranial, sponsored by Cerus Endovascular.

NCT04852783 is a Phase 4 study of Aneurysm, Intracranial that is active but no longer recruiting, run by Cerus Endovascular. The registered enrollment target is 250 participants, above the 215-participant average among 3 other Aneurysm, Intracranial trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04852783, a Phase 4 study of Aneurysm, Intracranial, is active but no longer recruiting, sponsored by Cerus Endovascular.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
250 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device.

Primary Outcome

Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.

Conditions Studied

Interventions

  • DEVICE Contour Neurovascular System

Study Locations (20)

New York

  • University at Buffalo Neurosurgery - Buffalo
  • NYU Langone Health - New York
  • Stony Brook Medicine - Stony Brook
  • Montefiore Medical Center - The Bronx
  • Westchester Medical Center - Valhalla

Pennsylvania

  • The Hospital of the University of Pennsylvania - Philadelphia
  • Thomas Jefferson University - Philadelphia
  • University of Pittsburgh Medical Center - Pittsburgh

Illinois

  • University of Chicago - Chicago
  • Advocate Aurora Health - Park Ridge

Massachusetts

  • Massachusetts General Hospital - Boston
  • UMASS Medical Center - Worcester

Colorado

  • Swedish Medical Center - Englewood

Florida

  • Baptist Health - Jacksonville

Kansas

  • University of Kansas Medical Center - Kansas City

North Carolina

  • NC Heart and Vascular Research LLC - Raleigh

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2021-08-06
Est. Completion 2030-02
Phase Phase 4
Cerus Endovascular

2 total trials

What the registry record for NCT04852783 still lists

NCT04852783 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 215-participant average among 3 other Aneurysm, Intracranial trials with a reported enrollment target (16% higher).

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

NCT04852783 names 20 study sites across 12 states, led by New York, Pennsylvania, Illinois.

Frequently Asked Questions

What is clinical trial NCT04852783 about?

NCT04852783 is a clinical study titled "US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair". The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device.

What is the current status of trial NCT04852783?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 250 participants. The study started on 2021-08-06. Estimated completion is 2030-02.

What conditions does trial NCT04852783 study?

This clinical trial studies the following conditions: Aneurysm, Intracranial.

What interventions are being tested in trial NCT04852783?

The interventions under investigation include: Contour Neurovascular System (DEVICE).

Who is sponsoring clinical trial NCT04852783?

This trial is sponsored by Cerus Endovascular, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04852783 being conducted?

This trial has 20 study locations across Colorado, Florida, Illinois, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04852783, the US trial registry maintained by the National Library of Medicine. NCT04852783 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.