Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection

Terminated

• Conditions: Cerebral Aneurysm
• Interventions: Device: Surpass Flow Diverter(s)

• Registration Number: NCT02281721
• Lead Sponsor: Stryker Neurovascular

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 Timeline

• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-02
• Study Start: 2015-03-18
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (19)

Queen Elizabeth Hospital; 🇬🇧 Birmingham, United Kingdom

Hopital Bretonneau; 🇫🇷 Tours, France

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Neuroradiologia Azienda ILSS9; 🇮🇹 Treviso, Italy

Fondation Rothschild; 🇫🇷 Paris, France

Hopital Jean Minjoz; 🇫🇷 Besançon, France

Freiburg University Hospital; 🇩🇪 Freiburg, Germany

Klinikum Kassel; 🇩🇪 Kassel, Germany

Universitätsmedizin Mannheim; 🇩🇪 Mannheim, Germany

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Spain

The Walton center; 🇬🇧 Liverpool, United Kingdom

Radboudumc; 🇳🇱 Nijmegen, Netherlands

Queen's Hospital of Romford, NHS Barking, Havering and Redbridge University Hospitals Trust; 🇬🇧 Romford, Essex, United Kingdom

San Martino Hospital; 🇮🇹 Genova, Italy

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Turun yliopistollinen keskussairaala; 🇫🇮 Turku, Finland

Karolinska University Hospital in Solna, Department of Neuroradiology; 🇸🇪 Stockholm, Sweden

APHP - Kremlin Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

AZ groeninge; 🇧🇪 Kortrijk, Belgium