Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial
Cerus Endovascular, Inc.
Summary
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 after 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 o…
Interventions
- DeviceContour Neurovascular System Treatment Attempt
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
Locations (9)
- Advocate Aurora HealthPark Ridge, Illinois
- University of Kansas Medical CenterKansas City, Kansas
- University at Buffalo NeurosurgeryBuffalo, New York
- Stony Brook UniversityStony Brook, New York
- NC Heart and Vascular Research LLCRaleigh, North Carolina
- University of PennsylvaniaPhiladelphia, Pennsylvania