Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection

Stryker Neurovascular150 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Cerebral Aneurysm

Interventions

Surpass Flow Diverter(s)DEVICE

Endovascular placement of a Surpass Flow Diverter(s) for the treatment of an intracranial aneurysm(s)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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).

Locations (19)

AZ groeninge

Kortrijk, Belgium

Helsinki University Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

Primary effectiveness based on the proportion of patients with 100% aneurysm occlusion

The proportion of patients with 100% aneurysm occlusion, based on an assessment of each patient's imaging at 12 months (± 180 days) post-procedure, and stratified across four aneurysm categories.

Time frame: 12 months

Secondary Outcomes

Technical success assessed by deployment of the device with complete coverage of the aneurysm neck

Successful deployment of the device with complete coverage of the aneurysm neck.

Time frame: Peri-procedural

Data from ClinicalTrials.gov

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