Trial document





This trial has been registered retrospectively.
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  DRKS00006103

Trial Description

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Title

Post Market Clinical Follow-Up Study of the Derivo® Embolisation Device

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Trial Acronym

Derivo

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Within the trial "Post Market Clinicl Follow-up of the Derivo Embolisation Device" the treatment of intracranial aneurysms (= diliatation of brain vessels) will be assessed. The treatment with the above mentioned Flow-Diverter will be performed within the intended use of the device.

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Brief Summary in Scientific Language

A recent metaanalysis published by Brinjikji including 29 studies and 1451 patients with 1654 aneurysms treated by FD reported a procedure-related morbidity and mortality of 5% and 4% respectively. The rate of post-operative subarachnoid and intraparenchymal hemorrhage were 3% each with significantly lower odds of perforator infarction among patients with anterior circulation aneurysms compared with those with posterior circulation aneurysms. The authors conclude that treatment of intracranial aneurysms with FD is feasible and effective with high complete occlusion rates. However they consider the risk of procedure-related morbidity and mortality non negligible (Brinjikji W1, Murad MH, Lanzino G, Cloft HJ, Kallmes DF. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke. 2013
Feb;44(2):442-7.). The study objective is to examine the safety and efficacy of aneurysm treatment with the Derivo flow-diverter with respect to the mid- and long-term clinical and angiographic outcomes.

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Organizational Data

  •   DRKS00006103
  •   2014/10/08
  •   [---]*
  •   yes
  •   Approved
  •   190/14 (§ 23b MPG), Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

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

  •   Treatment with Derivo Flow-Diverter
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Modified Rankin Score (mRS) at 18 months

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Secondary Outcome

1) Procedural result
• Number of flow-diverters successfully deployed over aneurysm neck in relation to the number of attempted flow-diverter treatments as determined by the core-lab.
• Wall apposition of the flow-diverter(s) per patient as determined by the core-lab:
1. correct wall apposition
2. gap between FD and vessel wall <25% of vessel diameter
3. gap between FD and vessel wall >25% of vessel diameter
• Time needed for Derivo deployment.
• Initial angiographic outcome: Core-lab evaluation of final controls with respect to the scale of Szikora
• In those patients were additional coils are being used for aneurysm treatment the Montreal classification will apply for determining the treatment result in addition to the Szikora classification.
• Procedural complication rate of aneurysm treatment

2) Post-procedural result
• Number of new neurological deficits immediately after flow-diverter implantation
• Initial clinical outcome: Comparison between initial Modified Ranking Scale (mRs) and mRs upon discharge. In those patient that had a procedural complication with subsequent stroke National Institutes of Health Stroke Scale (NIHSS) upon discharge.
• Midterm (3-6 months) clinical outcome: mRs
• Midterm (3-6 months) and longterm (12-18 months) angiographic outcome: Core-lab evaluation of mid-term angiographies with respect to the classification of Kamran Grading
• In those patients were additional coils are being used for aneurysm treatment the Montreal classification will apply for determining the treatment result in addition to the Kamran grading system.
• Quality of Life questionnaire SF-12 before treatment, after 3-6 and 12-18 months

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Countries of Recruitment

  •   Germany
  •   Poland
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/07/17
  •   100
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

1. Patients with intracranial aneurysms deemed treatable with the Derivo® flow-diverter
2. The target aneurysm cannot be treated with other endovascular techniques or there is a higher treatment risk with other endovascular or neurosurgical techniques. (= treatment within intended use)
3. The patients have read and understood the informations with respect to the study and have given their consent prior to aneurysm treatment with the Derivo® flow-diverter.
4. Modified Rankin score of 0 or 1

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Exclusion Criteria

1. Patients < 18 years of age
2. Patients with aneurysms related to arteriovenous malformations
3. Patients with known contraindications to antiplatelet therapy and/or anticoagulant therapy.
4. Pregnant or breast-feeding patients
5. Patients with confirmed subarachnoidal bleeding within the last two months
6. Patients likely to be unable to attend clinical and angiographic follow-up at 6 and 18 months
7. Patients with a contraindication according to the Instructions for use
- The size of the aneurysm and/or the size of the aneurysma forming vessel is not within the indicated area.
- An angiographically inappropriate vascular anatomy or vascular aberration for endovascular treatment.

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Klinik für Neuroradiologie
    • Mr.  Prof. Dr.  Christian  Taschner 
    • Breisacher Strasse 64
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Klinik für Neuroradiologie
    • Mr.  Prof. Dr.  Christian  Taschner 
    • Breisacher Strasse 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • ACANDIS GmbH
    • Theodor-Fahrner-Str. 6
    • 75177  Pforzheim
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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