Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection

Prospective, Observational, Multi-Center, Single-Arm, Consecutive Enrollment, Post-Marketing, International Registry of the Surpass™ Flow Diverter in Intracranial Arteries

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02281721

Enrollment

150

Registered

2014-11-03

Start date

2015-03-18

Completion date

2019-12-31

Last updated

2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Aneurysm

Brief summary

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.

Detailed 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.

Interventions

DEVICESurpass Flow Diverter(s)

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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).

Design outcomes

Primary

Measure	Time frame	Description
Primary effectiveness based on the proportion of patients with 100% aneurysm occlusion	12 months	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.

Secondary

Measure	Time frame	Description
Technical success assessed by deployment of the device with complete coverage of the aneurysm neck	Peri-procedural	Successful deployment of the device with complete coverage of the aneurysm neck.

Other

Measure	Time frame	Description
Safety outcomes assessed by neurological adverse events	Up to 5 years	Neurological adverse events

Countries

Belgium, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026