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

Conditions

• Cerebral Aneurysms

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Contour Neurovascular System Treatment Attempt — DEVICE
  The subject is brought into the procedure room, an angiogram on the day of the procedure indicates that the subject is anatomically eligible for the trial and any part of the investigational device comes in contact with the patient

Study Details

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

Key Dates

Start date

Jun 10, 2025

Status verified

Mar 2026

Primary completion

Oct 31, 2028

Completion

Jan 31, 2030

Study Design

Enrollment

250 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Attempt with the Contour Neurovascular System
  Subjects for which the index procedure (implant of the Contour Neurovascular System) was attempted.

Primary Outcome Measure

Incidence of death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year. [ Time Frame: From enrollment to 1 year ]

Central Contacts

• Amelia Saliba
  408-582-4552
  [email protected]
• Vanessa Sarge
  510-329-2048
  [email protected]

Locations (9)

Find similar trials in Park Ridge, IL