Clinical trial NCT02281721: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebral Aneurysm
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2014-11-02
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: Primary effectiveness based on the proportion of patients with 100% aneurysm occlusion
timeFrame: 12 months
Secondary outcomes:
measure: Technical success assessed by deployment of the device with complete coverage of the aneurysm neck
timeFrame: Peri-procedural
Other outcomes:
measure: Safety outcomes assessed by neurological adverse events
timeFrame: Up to 5 years
Locations:
city: Kortrijk
country: Belgium
facility: AZ groeninge
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala
city: Besançon
country: France
facility: Hopital Jean Minjoz
city: Le Kremlin-Bicêtre
country: France
facility: APHP - Kremlin Bicêtre
city: Paris
country: France
facility: Fondation Rothschild
city: Tours
country: France
facility: Hopital Bretonneau
city: Freiburg
country: Germany
facility: Freiburg University Hospital
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: Genova
country: Italy
facility: San Martino Hospital
city: Treviso
country: Italy
facility: Neuroradiologia Azienda ILSS9
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Stockholm
country: Sweden
facility: Karolinska University Hospital in Solna, Department of Neuroradiology
city: Romford
country: United Kingdom
facility: Queen's Hospital of Romford, NHS Barking, Havering and Redbridge University Hospitals Trust
state: Essex
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Liverpool
country: United Kingdom
facility: The Walton center
Study officials:
affiliation: Karolinska Hospital
name: Patrick A Brouwer, MD
role: PRINCIPAL_INVESTIGATOR
References: