Trial document



drksid header

  DRKS00014644

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00014644
  •   2018/05/07
  •   [---]*
  •   yes
  •   Approved
  •   12/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I67.10 -  [generalization I67.1: Cerebral aneurysm, nonruptured]
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   IV
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2018/05/22
  •   100
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Neuroradiologie. Universitätsklinik Freiburg.
    • Mr.  Dr. med.  Samer  Elsheikh 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Neuroradiologie. Universitätsklinik Freiburg.
    • Mr.  Dr. med.  Samer  Elsheikh 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Forschungskommission der Albert-Ludwigs-Universität Freiburg
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.