Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003132

Trial Description

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Title

GREAT - a randomised aneurysm trial

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Trial Acronym

GREAT

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URL of the Trial

http://www.thegreatstudy.org

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Brief Summary in Lay Language

Treatment of aneurysms in the head may be performed via the vessels of the human body. Aneurysms are being filled with small coils made of platinum. The major disadvantage of this technique lies in the fact that about one fourth of all aneurysms treated this way, will re-open. Patients with re-opened aneurysms are not 100% protected of an aneurysmal bleed.
A new class of coils aim at reducing the recanalisation rate by improving the aneurysm packing [HydroSoft coils (Hydrocoil Embolic
System, MicroVention Inc.)]. The present trial aims to compare major aneurysm recurrence rate on follow-up angiography at 18
months between patients treated with HydroSoft coils and patients treaterd with coils made of platinum. Patients from different centres in France, Germany, and Austria will be included.

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Brief Summary in Scientific Language

Endovascular coiling treatment is now the preferred treatment option for many intracranial
aneurysms. However, aneurysm recurrences and rebleeds are more frequent after endovascular
treatment than neurosurgical clipping. Therefore follow-up is mandatory and important to the
ongoing patient management. Major recurrences following endovascular treatment are associated
with both a high retreatment rate and with a substantially increased risk of aneurysmal rebleed.
Major recurrences occur in 15% to 19% of cases by 3-6 months, rising to 21% at a mean of 16
months of follow-up. An endovascular treatment that substantially reduced the major recurrence
rate would be expected to reduce both the rebleed rate and the retreatment rate, which would be to
the benefit of patients and health care systems alike. The HydroSoft coils (Hydrocoil Embolic
System, MicroVention Inc.) offer the prospect of improved aneurysm packing and angiographic
outcomes.
The present trial aims to compare major aneurysm recurrence rate on follow-up angiography at 18
months between patients allocated HydroSoft versus patients allocated bare platinum coiling.
Secondary outcomes to be compared between the two groups include: packing density; coil length
deployed; clinical outcome at 6 and 18 months post-coiling (measured by the modified Rankin
scale); re-bleed and re-treatment rates. 306 patients will be required to demonstrate a reduction in
major recurrence rate from 15% with bare platinum to 5% with HydroSoft treatment. Angiographic
analysis will be done by a core lab blinded to patient allocation.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00003132
  •   2011/07/06
  •   [---]*
  •   yes
  •   Approved
  •   077/09, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I67.1 -  Cerebral aneurysm, nonruptured
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Interventions/Observational Groups

  •   Endovascular coil embolisation with Hydrosoft coils
  •   Endovascular coil embolisation with bare platinum coils
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Composite outcome of major aneurysm recurrence on follow-up angiography and clinical outcome within 18 months
(Formulation of endpoint amended for clarification; primary endpoint combining angiographic outcomes [major recurrence], re-treatment, and clinical outcomes in the absence of angiographic follow-up was specified before the trial started)

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Secondary Outcome

Packing density, Coil length deployed, Clinical outcome at 6 and 18 months post-coiling, as measured by modified Rankin scale

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Countries of Recruitment

  •   Germany
  •   France
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/10/01
  •   500
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Aneurysm from 4 – 12 mm in diameter
• Anatomy such that endovascular occlusion is deemed possible (not necessarily probable)
• The neurointerventionist is content to use either bare platinum or HydroSoft depending on
randomisation result
• The neurointerventionalist is content not to use any other type of coated coil
• The patient has not been previously randomised into this trial
• Aneurysm has not previously been treated (by coiling or clipping).

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Exclusion Criteria

If the patient has more than one aneurysm requiring treatment at the same treatment episode they
will not be eligible for the trial. If treatment will be staged in a patient with multiple aneurysms and
only one aneurysm will be treated at one sitting then the patient is eligible. However, a patient may
not be randomised into the study more than once.
From the moment of randomisation, the patient is in the trial whether they receive trial treatment or
not, and will be followed up and accounted for in the final analysis (intention-to-treat).
Death or procedural/disease related morbidity may result in some subjects not having check
angiography (or MRA if unit uses this as standard mode of follow-up). These patients will be
counted as poor outcomes in the primary analysis.
Retreatment of previously coiled or clipped aneurysm is an exclusion criterion.
Use of coil assist devices (stent, balloon, trispan etc) should be recorded but is not an exclusion
criterion. It must be recorded in order to ascertain if any difference in use between control &
HydroCoil groups acts as a potential confounding variable.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Neuroradiologie Neurozentrum Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.  Christian  Taschner 
    • Breisacher Strasse 64
    • 79102  FREIBURG
    • Germany
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    • Klinik für Neuroradiologie Neurozentrum Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.  Christian  Taschner 
    • Breisacher Strasse 64
    • 79102  FREIBURG
    • Germany
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    • Klinik für Neuroradiologie Neurozentrum Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.  Christian  Taschner 
    • Breisacher Strasse 64
    • 79102  FREIBURG
    • Germany
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Sources of Monetary or Material Support

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    • Microvention Deutschland GmbH
    • Mr.  Markus  Huber 
    • Berliner Allee 61
    • 40212   DÜSSELDORF
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/05/02
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.