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US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair | Clinical Trials | Clareo Health

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

NCT04852783•Cerus Endovascular, Inc.

Summary

Detailed Description

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. This trial is a prospective, multicenter single-arm study. Up to 220 subjects will be enrolled at up to 20 participating investigational sites.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient is 18-75 years of age at the time of screening.
•2. Patient has a single ruptured or unruptured IA requiring treatment. If the patient has an additional IA requiring treatment, the additional IA must not require treatment within 60 days of the index procedure.
•3. The target IA must have the following characteristics:
•* Saccular morphology
•* Located at a bifurcation in the anterior or posterior circulation
•* Aneurysm neck diameter between 2 and 10 mm and aneurysm equatorial diameter between 2 and 10.5 mm
•* Wide-necked, defined as neck size ≥ 4 mm or a dome/neck ratio \< 2
•4. Patient may be treated with Contour without the use of additional implanted devices.
•5. Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
•6. 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.
+4 more criteria

Exclusion Criteria

•1. Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee
•2. Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device
•3. Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device.
•4. Contraindication to anticoagulants or anti-platelet medications
•5. Stenosis of the target IA's parent vessel is \>50%
•6. Anticoagulation medications (e.g., warfarin) that cannot be discontinued
•7. Acute / chronic renal failure (unless on dialysis) and/or creatinine \> 2.00 mg/dl or \> 182 μmol/L
•8. Vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
•9. Clinical, angiographic or CT evidence of vasospasm, vasculitis, an intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation.
•10. Conditions placing them at high risk for ischemic stroke or had exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 60-days.
+7 more criteria

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

Key Dates

Start Date

August 6, 2021

Primary Completion Date

February 1, 2026

Completion Date

February 1, 2030

Last Updated

January 22, 2026

Enrollment

250

ACTUAL participants

Conditions

Aneurysm, Intracranial

Interventions

Contour Neurovascular System

DEVICE

An EFS Assessing the Electrolytic eCLIPs System for Treatment of Intracranial Aneurysms

NCT04886505

Aneurysm, Intracranial

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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