Trial document




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  DRKS00000643

Trial Description

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Title

Clinical Observation of the Acandis® Neuroclosed Stent System

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Trial Acronym

Acandis® Neuroclosed Study

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URL of the Trial

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Brief Summary in Lay Language

The Acandis® Neuroclosed Stent (lattice-like vessel bracket) is used for the treatment of patients with brain aneurysm (bulge of a blood vessel). Goal of the study is to show that the Acandis® Neuroclosed Stent, which is similar to other legally marketed stents, fulfills the expectations concerning exact placement and delivery, appostion to the vessel wall, successful coiling (filling of the aneurysm with platinium coils) and low product related complication rate.

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Brief Summary in Scientific Language

Proof that the Acandis® Neuroclosed Stent, which is similar to other selfexpanding stents used for assistance of endovascular treatment of intracranial aneurysms, fulfills the expectations of the improved stent design concerning exact placement and delivery, appostion to the vessel wall, successful coiling and low periprocedural complication rate.

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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

  •   DRKS00000643
  •   2011/01/11
  •   [---]*
  •   no
  •   Approved
  •   320/09, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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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

  •   Observation group:
    Patients with intracranial Aneurysms scheduled for endovascular treatment and need for stent reconstruction of the parent vessel for coiling
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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

Technical Feasibility:
• Successful access to the site of the aneurysm with the Acandis® Neuroclosed delivery catheter system
• Exact stent placement across the neck of the aneurysm
• Successful microcatheter access to the aneurysm through the stent filaments and coiling of the aneurysm

Safety:
• Rate of procedure or device related adverse events with new neurologic deficits during the first 30 days and after 6 months
• Procedure related stroke, intracranial hemorrhage and death

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Secondary Outcome

Angiographic Results
• Patency of the parent vessel after the procedure and after 6 months.
• Stent apposition to the vessel wall
• Occlusion of the aneurysm according to Raymond classification after the procedure and after 6 months
• Rate of in-stent-stenosis after 6 months

Technical and Clinical Results
• Rate of clinically silent complications
• Stent misplacement or dislodgement
• Coil protrusion into stent
• Proc. related thrombembolic complications
• Clinical silent perforations
• Clinical outcome according to mRS after 30 days and 6 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/01/10
  •   25
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Candidates for this Study must meet all of the following criteria to be enrolled in the Study. The information will be recorded on the Inclusion/Exclusion Criteria Case Report Form (CRF).

• Subjects with unruptured saccular intracranial aneurysms.
• Wide neck or other indication justifying stent reconstruction of parent vessel for coiling.
• Maximal aneurysm diameter between 2 and 20 mm
• Normal arterial diameter adjacent to the aneurysm diameter < 4.0 mm
• Final inclusion time-point after angiographic planning of the procedure
• Subject age > 18 years and < 80 years
• Has been informed of the nature of the study, agrees to its provisions and provided written (or witnessed verbal) informed consent; which was approved by the appropriate Ethics Committee (EC) of the respective clinical site

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Exclusion Criteria

Candidates will be ineligible for enrollment in the study if any of the following conditions apply. The information will be recorded on the Inclusion/Exclusion Criteria CRF.

• Subjects with giant aneurysms > 20 mm in size
• Fusiform aneurysms without any unilateral sac.
• Acute dissections or peripheral aneurysms beyond second order intracranial arteries.
• Subjects with subarachnoid hemorrhage
• Subjects with major disability (mRS > 2)
• Subjects who are unable to give informed consent without legal assistance
• Subjects with contraindications for placement and delivery of selfexpanding stents (e.g., extreme tortuosity, other access problems)
• Subjects with contraindications or intolerance of double antiplatelet therapy with Clopidogrel and Aspirin.
• Known allergic reaction against nitinol alloys
• Hemoglobin level < 10 g/dL
• Platelet count < 100,000
• Un-correctable bleeding diathesis
• Subjects with progressive or unstable neurological deficits
• Subjects with indications for oral anticoagulation
• Co-morbidity (f. e. malignant tumors, major strokes, renal insufficiency) with reduced life expectancy of less than one year or significantly increased risk during stent-assisted coiling
• Protocol non-compliance or logistics that would limit follow-up (e.g., Subject lives far from site, substance abuse, psychosocial issues, etc.)
• Women who are pregnant or plan to become pregnant during the study
• Subjects enrolled in any concurrent study, without written approval from Acandis that may confound the results of this Study
• Previous endovascular stents at the same aneurysm
• Embolization of the aneurysm with liquid embolic agents or other materials different from bare or coated platinum coils.
• High–grade stenosis or vessel deformity in the vessel territory planed to be treated

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Acandis GmbH & Co. KG
    • Mr.  Dr.  Karl  Beck 
    • Theodor-Fahrner-Straße 6
    • 75177  Pforzheim
    • Germany
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    • Acandis GmbH & Co. KG
    • Mr.  Dr.  Karl  Beck 
    • Theodor-Fahrner-Straße 6
    • 75177  Pforzheim
    • Germany
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    • Acandis GmbH & Co. KG
    • Mr.  Dr.  Karl  Beck 
    • Theodor-Fahrner-Straße 6
    • 75177  Pforzheim
    • Germany
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Sources of Monetary or Material Support

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    • Acandis GmbH & Co. KG
    • Mr.  Dr.  Karl  Beck 
    • Theodor-Fahrner-Straße 6
    • 75177  Pforzheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/02/01
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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.