Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection

Stryker

Status: Terminated

Conditions: Cerebral Aneurysm

Treatments: Device: Surpass Flow Diverter(s)

Study type: Observational

Funder types: Industry

Identifiers

NCT02281721

T4029

Details and patient eligibility

About

The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed.

Full description

This will be a prospective, observational, multi-center, single-arm, post-marketing, international registry with consecutive enrollment of a minimum of 150 patients treated with the Surpass Flow Diverter in accordance with the standard of care at up to 30 registry sites.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are to be treated with a Surpass Flow Diverter(s) will be eligible to participate in this registry. Patients will be enrolled on a consecutive basis.

Exclusion criteria

• This is a standard of care registry. Patients should be excluded if standard of care at a given site is such that they are not eligible for treatment with a Surpass Flow Diverter(s).

Trial design

150 participants in 1 patient group

Single Group; Surpass Flow Diverter(s)

Description:

Individuals using the Surpass Flow Diverter(s)

Treatment:

Device: Surpass Flow Diverter(s)