NCT02281721

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
9 countries

19 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

March 18, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

4.7 years

First QC Date

October 30, 2014

Last Update Submit

July 8, 2021

Conditions

Cerebral Aneurysm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Technical success assessed by deployment of the device with complete coverage of the aneurysm neck

    Peri-procedural

Other Outcomes (1)

  • Safety outcomes assessed by neurological adverse events

    Up to 5 years

Study Arms (1)

Single Group; Surpass Flow Diverter(s)

Individuals using the Surpass Flow Diverter(s)

Device: Surpass Flow Diverter(s)

Interventions

Surpass Flow Diverter(s)DEVICE

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

Single Group; Surpass Flow Diverter(s)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

AZ groeninge

Kortrijk, 8500, Belgium

Location

Helsinki University Hospital

Helsinki, 00260, Finland

Location

Turun yliopistollinen keskussairaala

Turku, 20521, Finland

Location

Hopital Jean Minjoz

Besançon, 25030, France

Location

APHP - Kremlin Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Fondation Rothschild

Paris, 75020, France

Location

Hopital Bretonneau

Tours, 37 000, France

Location

Freiburg University Hospital

Freiburg im Breisgau, 79085, Germany

Location

Klinikum Kassel

Kassel, 34125, Germany

Location

Universitätsmedizin Mannheim

Mannheim, 68167, Germany

Location

San Martino Hospital

Genova, 16132, Italy

Location

Neuroradiologia Azienda ILSS9

Treviso, 31100, Italy

Location

Radboudumc

Nijmegen, 6500, Netherlands

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Karolinska University Hospital in Solna, Department of Neuroradiology

Stockholm, 171 16, Sweden

Location

Queen's Hospital of Romford, NHS Barking, Havering and Redbridge University Hospitals Trust

Romford, Essex, RM7 0AG, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

The Walton center

Liverpool, L9 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Patrick A Brouwer, MD

    Karolinska Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 3, 2014

Study Start

March 18, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 14, 2021

Record last verified: 2021-07

Locations

IT(2)BE(1)ES(2)GB(3)NL(1)FI(2)SE(1)FR(4)DE(3)