Trial document




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  DRKS00014644

Trial Description

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Title

Contrast enhancement following coiling of intracranial aneurysms in 3T MRI and its relationship to aneurysm recurrence following endovascular treatment

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

A recurrence following treatment of an intracranial aneurysm using coils is a well known phenomenon. For earl recognition of such recurrences regular follow-up examinations using magnetic resonance tomography are recommended. These examinations are usually carried out without using contrast media. Enhancement following application of contrast media is sometimes observed. In our study we want to examine such contrast enhancement more closely, especially its relation with the occurrence of aneurysm recurrence.

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Brief Summary in Scientific Language

The safety and efficacy of coiling both of ruptured and unruptured aneurysms was shown in many large studies. The main drawback of endovascular coiling is the recanalization of an initially occluded aneurysm. This occurs in about one-fourth to one-third of patients. In about 9% of patients a retreatment is required.
There has been extensive research in the factors statistically favoring Aneurysm recurrence. Known factors include the size of the aneurysm, rupture status and the degree of completeness of aneurysm occlusion. This is in turn associated with the packing density of the aneurysm and the use of adjunctive balloon remodeling or stent placement. Other factors possibly affecting the rate of recurrence include the location of the aneurysm.
Following coiling aneurysms undergo a prolonged healing process ideally ending in complete endothelialisation of the aneurysm neck. There are many mechanisms leading to aneurysm recurrence. Coil compaction may occur secondary to poor packing or to aneurysm growth. In ruptured aneurysms coil extrusion into the subarachnoid space may lead to recanalization of portions of the aneurysm. In Aneurysms with an intraluminal thrombus, coils can gradually penetrate into the thrombus resulting in aneurysm recurrence. This can be facilitated by poor thrombus organization due to the biologically inert platinum coil material, instability of the fresh, unorganized thrombus and degradation by thrombolysis, continued transmission of pulsations from the parent vessel into the aneurysm, incomplete neointimal coverage of the aneurysm neck and neovessel formation in the lumen of the aneurysm, exposing the aneurysmal cavity to continuous blood flow. Literature studying aneurysm healing in humans is limited while studies of animal models are of limited value because these models do not emulate the exact conditions in humans. Aneurysm healing involves a cascade of events occurring within the aneurysm and at its neck. After one year the coils are usually incorporated in the aneurysm wall and the inflammatory reaction could still be seen in the aneurysms.
Recently developed MRI-techniques allow the direct imaging of the vessel wall of intracranial vessels. These sequences have the advantage of suppression the signal of surrounding cerebrospinal fluid as well as the signal from intravascular blood, which may obscure the changes of the vessel wall.
We aim to examine the hypothesis that the contrast enhancement is associated with the healing process following aneurysm treatment, and as a corollary contrast enhancement is associated with the stability of the result following aneurysm treatment.

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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

  •   DRKS00014644
  •   2018/05/07
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  •   yes
  •   Approved
  •   12/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   I67.10 -  [generalization I67.1: Cerebral aneurysm, nonruptured]
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Interventions/Observational Groups

  •   Following Coiling a minimum of 4 MRI Follow-up examinations are recommended. In these follow-up examination the patients will receive gadolinium containing contrast medium in the usual dose. There will be no extra examinations following taking part in the study.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   IV
  •   N/A
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Primary Outcome

Contrast enhancement of treated intracranial aneurysms in serial MRI-examinations 6, 18, 36 and 60 months following treatment.

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Secondary Outcome

Recurrence following Coiling in serial MRI/ MR-angiographic examinations 6, 18, 36 and 60 months following treatment.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/05/22
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Clinically indicated follow-up MRI/MRA examination after coiling of a ruptured or unruptured cerebral aneurysm.

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Exclusion Criteria

Known Contraindication to Gadolinium contrast agents.
Patients, who for any reason are unable to personally give an informed consent to the study

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Klinik für Neuroradiologie. Universitätsklinik Freiburg.
    • Mr.  Dr. med.  Samer  Elsheikh 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
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    • Klinik für Neuroradiologie. Universitätsklinik Freiburg.
    • Mr.  Dr. med.  Samer  Elsheikh 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Forschungskommission der Albert-Ludwigs-Universität Freiburg
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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