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Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection

NCT ID: NCT02281721

Last Updated: 2021-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-18

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebral Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Group; Surpass Flow Diverter(s)

Individuals using the Surpass Flow Diverter(s)

Surpass Flow Diverter(s)

Intervention Type DEVICE

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

Interventions

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Surpass Flow Diverter(s)

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Neurovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick A Brouwer, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Hospital

Locations

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AZ groeninge

Kortrijk, , Belgium

Site Status

Helsinki University Hospital

Helsinki, , Finland

Site Status

Turun yliopistollinen keskussairaala

Turku, , Finland

Site Status

Hopital Jean Minjoz

Besançon, , France

Site Status

APHP - Kremlin Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Fondation Rothschild

Paris, , France

Site Status

Hopital Bretonneau

Tours, , France

Site Status

Freiburg University Hospital

Freiburg im Breisgau, , Germany

Site Status

Klinikum Kassel

Kassel, , Germany

Site Status

Universitätsmedizin Mannheim

Mannheim, , Germany

Site Status

San Martino Hospital

Genova, , Italy

Site Status

Neuroradiologia Azienda ILSS9

Treviso, , Italy

Site Status

Radboudumc

Nijmegen, , Netherlands

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Site Status

Karolinska University Hospital in Solna, Department of Neuroradiology

Stockholm, , Sweden

Site Status

Queen's Hospital of Romford, NHS Barking, Havering and Redbridge University Hospitals Trust

Romford, Essex, United Kingdom

Site Status

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status

The Walton center

Liverpool, , United Kingdom

Site Status

Countries

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Belgium Finland France Germany Italy Netherlands Spain Sweden United Kingdom

Other Identifiers

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T4029

Identifier Type: -

Identifier Source: org_study_id

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