Contour Neurovascular System for Brain Aneurysm
(NECC Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen byPascal M Jabbour, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Cerus Endovascular, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pascal M Jabbour, MD

Principal Investigator

Jefferson University Hospitals

Demetrius Lopes, MD

Principal Investigator

Advocate Medical Group - Brain and Spine Institute

Eligibility Criteria

This trial is for adults aged 18-75 with certain wide-necked brain aneurysms sized between 2 and 10.5 mm that require repair, who can follow the study schedule. Excluded are those on non-stop anticoagulants, with severe kidney issues not on dialysis, pregnant or breastfeeding women, participants in other conflicting studies, individuals allergic to device materials or contrast dye, and those with conditions affecting study compliance.

Inclusion Criteria

I am between 18 and 75 years old.

Patient or legally authorized representative has signed and dated an institutional review board (IRB)/Ethics Committee (EC)-approved written informed consent prior to initiation of any study procedures

If you have had a burst blood vessel in your brain, you must meet the guidelines from the American Heart Association and American Stroke Association for how it should be managed.

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Exclusion Criteria

Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device

I have had symptoms or conditions that increase my risk of a stroke in the last 2 months.

I am on blood thinners that I cannot stop taking.

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Treatment Details

Interventions

Contour NEurovasCular System™ (Procedure)

Trial OverviewThe Contour Neurovascular System™ is being tested for its safety and effectiveness in repairing wide-necked bifurcated saccular intracranial aneurysms. The data collected will support a premarket approval application to the FDA.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Attempted to TreatExperimental Treatment1 Intervention

Attempted to treat (ATT) with the investigational device