Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial (NEXT Trial)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCerus Endovascular, Inc.

About this trial

The goal of this clinical trial is to collect additional data to demonstrate if the Contour Neurovascular System (CNS) is a safe and effective treatment of wide-necked, saccular, intracranial aneurysms.

Participants will:

Undergo treatment with the Contour Neurovascular System Complete follow-up visits at 1month, 12months, and 24 months, following their procedure Report any adverse events to their study team

Eligibility criteria

Qualifiers

Patient is 18-75 years of age at the time of screening.

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 after the index procedure.

Saccular morphology

Located at a bifurcation in the anterior or posterior circulation

Disqualifiers

Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee

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

Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device.

Contraindication to anticoagulants or anti-platelet medications

Trial design

Treatments tested in this trial

  • Contour Neurovascular System Treatment Attempt

Treatment groups

250 Participants
are divided into 1 treatment group

Sponsors and collaborators