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Endovascular Treatment of Intracranial Aneurysms with Surpass Flow Diverter. A retrospective multicenter study with respect to clinical and angiographic outcome

Organizational Data

DRKS-ID:
DRKS00006881
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2015-04-10
Last update in DRKS:
2017-02-08
Registration type:
Retrospective

Acronym/abbreviation of the study

SUR-POST

URL of the study

http://Nicht vorgesehen

Brief summary in lay language

Aneurysms of the brain are standardly treated by clipping or endovascular coiling. A new approach is the usage of so called Flow Diverters. These are a special kind of stents with tight mashes. They divert the blood-flow along the aneurysm reducing the intraaneurysmal flow. This leads to subsequent thombosis and shrinkage of the aneurysm afterwards. The use of flow diverters is currently restricted to large and complex-formed aneurysms. The aim of the study is to evaluate the efficacy of this new treatment option in aneurysms of the posterior circulation. This is done by continual documentation of the clinical state of the patients which have received that treatment.

Brief summary in scientific language

A great number of prospective studies were able to prove the clinical effectiveness of the endovascular treatment of intracranial aneurysms with coils. However the classic coil-embolization finds its limit when it comes to large aneurysms or aneurysms with a wide neck. Here methods like remodelling-balloons or stents gained acceptance. Another approach consists of the so called Flow Diverters (FD). FD are stents with a very high density which lead to aneurysm occlusion by reducing the flow into the aneurysm. The effectiveness of FD has been shown in a variety of register studies. The placement of FD in the posterior circulation is a matter of on-going debate. The major risk seems occlusion of perforating arteries deriving from the distal segments of the vertebral arteries, as well as the basilar artery, and the posterior cerebral arteries. The Surpass FD has CE markage for intracranial aneurysm treatment. The Surpass FD is a FD with a particularly mesh density, when compared to the other FD available on the market. The aim of this retrospective multicentre study is to analyze the effectiveness of the Surpass Flow Diverter for the treatment of aneurysms located within the posterior circulation with a special focus on the clinical outcome.

Health condition or problem studied

Free text:
intracranial aneurysm, posterior circulation
ICD10:
I67.1 - Cerebral aneurysm, nonruptured
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Any male or female patient between 16 and 79 years of age that received FD treatment with Surpass for aneurysmatic disease within the posterior circulation between 07/2010 and 03/2015.

Endpoints

Primary outcome:
Mortality in patients with intracranial aneurysms of the posterior circulation after flow-diverter treatment with the Surpass flow diverter (after 12 months) and complete occlusion in angiographic follow up (after 12 months).
Secondary outcome:
Technical success rate, complication rate of aneurysm treatment with the Surpass flow-diverter, new neurological deficits after 24 hours, modified Rankin Scale (mRS) at discharge and morbidity (mRS 3 till 5) at follow-up.

Study Design

Purpose:
Treatment
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Argentina
  • Denmark
  • France
  • Germany
  • Hungary
  • Japan
  • Netherlands
  • United States
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Kassel
  • Medical center Budapest
  • University medical center Neuroradiologie Freiburg im Breisgau
  • Medical center Neuroradiologie Besancon
  • University medical center Neurochirurgie Nijmegen
  • Medical center Magdeburg
  • Medical center Kobe
  • Medical center Odense
  • Medical center Hamburg Barmbek
  • Medical center Rotterdam
  • Medical center Hamburg Altona
  • Medical center Buenos Aires
  • Medical center Montpellier
  • Medical center Paris
  • Medical center Tampa

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2014-10-15
Planned study completion date:
No Entry
Actual Study Completion Date:
2015-06-15
Target Sample Size:
53
Final Sample Size:
52

Inclusion Criteria

Sex:
All
Minimum Age:
16 Years
Maximum Age:
80 Years
Additional Inclusion Criteria:
Any patient that received FD treatment with Surpass for aneurysmatic disease within the posterior circulation.

Exclusion Criteria

Patients < 16 years of age

Addresses

Primary Sponsor

Universitätsklinikum Freiburg Abteilung der Neuroradiologie
Prof. Dr. Christian Taschner
Breisacher Straße 64
79106 Freiburg
Germany
Telephone:
+49 761 270-50010
Fax:
+49 761 270-51950
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum Freiburg Abteilung der Neuroradiologie
Prof. Dr. Christian Taschner
Breisacher Straße 64
79106 Freiburg
Germany
Telephone:
+49 761 270-50010
Fax:
+49 761 270-51950
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de

Contact for Public Queries

Universitätsklinikum Freiburg Abteilung der Neuroradiologie
Prof. Dr. Christian Taschner
Breisacher Straße 64
79106 Freiburg
Germany
Telephone:
+49 761 270-50010
Fax:
+49 761 270-51950
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de

Principal Investigator

Universitätsklinikum Freiburg Abteilung der Neuroradiologie
Prof. Dr. Christian Taschner
Breisacher Straße 64
79106 Freiburg
Germany
Telephone:
+49 761 270-50010
Fax:
+49 761 270-51950
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Universitätsklinikum Freiburg Abteilung der Neuroradiologie
Breisacher Straße 64
79106 Freiburg
Germany
Telephone:
+49 761 270-50010
Fax:
+49 761 270-51950
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2014-08-06
Ethics committee number:
376/14
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-10-09

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Abstract
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry