Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection

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Brief Title

Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection

Official Title

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

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.
    


Study Type

Observational [Patient Registry]


Primary Outcome

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

Secondary Outcome

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

Condition

Cerebral Aneurysm

Intervention

Surpass Flow Diverter(s)

Study Arms / Comparison Groups

 Single Group; Surpass Flow Diverter(s)
Description:  Individuals using the Surpass Flow Diverter(s)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

150

Start Date

March 18, 2015

Completion Date

March 2021

Primary Completion Date

December 2019

Eligibility Criteria

        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).
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Patrick A Brouwer, MD, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT02281721

Organization ID

T4029


Responsible Party

Sponsor

Study Sponsor

Stryker Neurovascular


Study Sponsor

Patrick A Brouwer, MD, Principal Investigator, Karolinska Hospital


Verification Date

May 2020