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

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.

Study Overview

• Status: Terminated
• Conditions: Cerebral Aneurysm
• Intervention / Treatment: Device: Surpass Flow Diverter(s)

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
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Belgium
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
• Finland
  • Helsinki, Finland, 00260
    • Helsinki University Hospital
  • Turku, Finland, 20521
    • Turun Yliopistollinen Keskussairaala
• France
  • Besançon, France, 25030
    • Hôpital Jean Minjoz
  • Le Kremlin-Bicêtre, France, 94270
    • APHP - Kremlin Bicêtre
  • Paris, France, 75020
    • Fondation Rothschild
  • Tours, France, 37 000
    • Hôpital Bretonneau
• Germany
  • Freiburg, Germany, 79085
    • Freiburg University Hospital
  • Kassel, Germany, 34125
    • Klinikum Kassel
  • Mannheim, Germany, 68167
    • Universitätsmedizin Mannheim
• Italy
  • Genova, Italy, 16132
    • San Martino Hospital
  • Treviso, Italy, 31100
    • Neuroradiologia Azienda ILSS9
• Netherlands
  • Nijmegen, Netherlands, 6500
    • Radboudumc
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Santander, Spain, 39008
    • Hospital Universitario Marques de Valdecilla
• Sweden
  • Stockholm, Sweden, 171 16
    • Karolinska University Hospital in Solna, Department of Neuroradiology
• United Kingdom
  • Birmingham, United Kingdom
    • Queen Elizabeth Hospital
  • Liverpool, United Kingdom, L9 7LJ
    • The Walton Center
  • Essex
    • Romford, Essex, United Kingdom, RM7 0AG
      • Queen's Hospital of Romford, NHS Barking, Havering and Redbridge University Hospitals Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

For the primary endpoint, the evaluable patient population will consist of all individuals treated with the Surpass Flow Diverter(s) who have provided consent, and who have completed their 12 month follow-up assessment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Group; Surpass Flow Diverter(s); Individuals using the Surpass Flow Diverter(s)	Device: Surpass Flow Diverter(s); Endovascular placement of a Surpass Flow Diverter(s) for the treatment of an intracranial aneurysm(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Peri-procedural

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stryker Neurovascular
• Investigators: Principal Investigator: Patrick A Brouwer, MD, Karolinska Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 2, 2014

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Calcium Carbonate
• Other Study ID Numbers: T4029