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ACTIVE NOT RECRUITING
NCT04852783
PHASE4

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

Sponsor: Cerus Endovascular, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2021-08-06

Completion Date

2030-02

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DEVICE

Contour Neurovascular System

Endovascular embolization of wide-necked, bifurcated saccular intracranial aneurysms.

Locations (20)

Swedish Medical Center

Englewood, Colorado, United States

Baptist Health

Jacksonville, Florida, United States

University of Chicago

Chicago, Illinois, United States

Advocate Aurora Health

Park Ridge, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

UMASS Medical Center

Worcester, Massachusetts, United States

University at Buffalo Neurosurgery

Buffalo, New York, United States

NYU Langone Health

New York, New York, United States

Stony Brook Medicine

Stony Brook, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Westchester Medical Center

Valhalla, New York, United States

NC Heart and Vascular Research LLC

Raleigh, North Carolina, United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Alejandro Spiotta

Charelston, South Carolina, United States

Semmes-Murphy Clinic

Memphis, Tennessee, United States

Medical City Plano

Plano, Texas, United States

Swedish Neuroscience Institute

Seattle, Washington, United States