Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection

Cerebral Aneurysm Clinical Trial

Official title:

Prospective, Observational, Multi-Center, Single-Arm, Consecutive Enrollment, Post-Marketing, International Registry of the Surpass™ Flow Diverter in Intracranial Arteries

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02281721
• Other study ID #: T4029
• Status: Terminated
• 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
• 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).

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm

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