Clinical Trial: Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Multicenter Randomized Study for Medico-economic Evaluation of Embolization With Flow Diverter Stent in the Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial

Brief Summary: Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique has recently been developed, using flow diverter stents without associated coils. Clinical results already published are encouraging but have to be confirmed. Furthermore, these medical devices are expensive in comparison to the coiling strategy. The purpose of this study is to compare the clinical efficacy, safety, and cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted saccular intracranial aneurysms.

Detailed Summary: Main Outcome Measure: Percentage of patients with an aneurysm with complete occlusion, defined as the absence of visible blood flow to the consideration of angiography performed 12 months post-endovascular intervention.
Sponsor: Hospices Civils de Lyon

Current Primary Outcome: Percentage of patients with complete occlusion of the treated aneurysm, defined as the absence of visible blood flow on angiography performed 12 months after endovascular procedure. [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Occurrence of a death during or after endovascular procedure [ Time Frame: hospitalization for the endovascular procedure, up to 7 days ]
  • Occurrence of a death whatever the cause [ Time Frame: 24 months ]
  • Occurrence of a death due to aneurysm rupture [ Time Frame: 24 months ]
  • Occurrence of an intracranial hemorrhagic from rupture of the aneurysm [ Time Frame: 24 months ]
  • Occurrence of an ischemic stroke due to thrombosis [ Time Frame: 24 months ]
  • Occurrence of a non-cerebral bleeding [ Time Frame: 24 months ]
  • Rate of patients with neurological deficits by mass effect [ Time Frame: hospitalization for the endovascular procedure, an expected average of 1 hour; 3 months, 6 months and 12 months post-intervention ]
  • Retreatment of the aneurysm [ Time Frame: 24 months ]
  • Rate of technical complications [ Time Frame: Endovascular procedure an expected average of 1 hour ]
  • Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others [ Time Frame: Endovascular procedure an expected average of 1 hour ]
  • Rate of correct placement of flow diverter stents, according to the investigator [ Time Frame: Endovascular procedure an expected average of 1 hour ]
  • mean duration of irradiation related to angiography [ Time Frame: Endovascular procedure an expected average of 1 hour ]
  • Rate of patients for each class of occlusion [ Time Frame: Endovascular procedure , an expected average of 1 hour and 12 months ]
    The classes of occlusion are defined as : complete occlusion, residual neck, residual aneurysm, for the group treated with coiling procedure; grades 0 to 4 according to the scale of Kamran, for the group treated with flow diversion
  • Modified Rankin score [ Time Frame: Inclusion, 3 months and 12 months ]
  • National Institute of Health Stroke Score (NIHSS) [ Time Frame: Inclusion, 3 months and 12 months ]
  • Evolution of the Barthel index [ Time Frame: : Inclusion and 12 months ]
  • Incremental cost-effectiveness ratio [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: November 20, 2012
Date Started: November 2012
Date Completion: November 2017
Last Updated: December 10, 2013
Last Verified: December 2013