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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02281721
Other study ID # T4029
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 18, 2015
Est. completion date December 2019

Study information

Verified date July 2021
Source Stryker Neurovascular
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 150
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium AZ groeninge Kortrijk
Finland Helsinki University Hospital Helsinki
Finland Turun yliopistollinen keskussairaala Turku
France Hopital Jean Minjoz Besançon
France APHP - Kremlin Bicêtre Le Kremlin-Bicêtre
France Fondation Rothschild Paris
France Hopital Bretonneau Tours
Germany Freiburg University Hospital Freiburg
Germany Klinikum Kassel Kassel
Germany Universitätsmedizin Mannheim Mannheim
Italy San Martino Hospital Genova
Italy Neuroradiologia Azienda ILSS9 Treviso
Netherlands Radboudumc Nijmegen
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitario Marques de Valdecilla Santander
Sweden Karolinska University Hospital in Solna, Department of Neuroradiology Stockholm
United Kingdom Queen Elizabeth Hospital Birmingham
United Kingdom The Walton center Liverpool
United Kingdom Queen's Hospital of Romford, NHS Barking, Havering and Redbridge University Hospitals Trust Romford Essex

Sponsors (1)

Lead Sponsor Collaborator
Stryker Neurovascular

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety outcomes assessed by neurological adverse events Neurological adverse events Up to 5 years
Primary 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 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
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