Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms (EVIDENCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01811134
First received: November 20, 2012
Last updated: December 10, 2013
Last verified: December 2013

November 20, 2012
December 10, 2013
November 2012
November 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01811134 on ClinicalTrials.gov Archive Site
  • Occurrence of a death during or after endovascular procedure [ Time Frame: hospitalization for the endovascular procedure, up to 7 days ] [ Designated as safety issue: Yes ]
  • Occurrence of a death whatever the cause [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Occurrence of a death due to aneurysm rupture [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Occurrence of an intracranial hemorrhagic from rupture of the aneurysm [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Occurrence of an ischemic stroke due to thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Occurrence of a non-cerebral bleeding [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Retreatment of the aneurysm [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Rate of technical complications [ Time Frame: Endovascular procedure an expected average of 1 hour ] [ Designated as safety issue: Yes ]
  • Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others [ Time Frame: Endovascular procedure an expected average of 1 hour ] [ Designated as safety issue: Yes ]
  • Rate of correct placement of flow diverter stents, according to the investigator [ Time Frame: Endovascular procedure an expected average of 1 hour ] [ Designated as safety issue: No ]
  • mean duration of irradiation related to angiography [ Time Frame: Endovascular procedure an expected average of 1 hour ] [ Designated as safety issue: No ]
  • Rate of patients for each class of occlusion [ Time Frame: Endovascular procedure , an expected average of 1 hour and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • National Institute of Health Stroke Score (NIHSS) [ Time Frame: Inclusion, 3 months and 12 months ] [ Designated as safety issue: No ]
  • Evolution of the Barthel index [ Time Frame: : Inclusion and 12 months ] [ Designated as safety issue: No ]
  • Incremental cost-effectiveness ratio [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
Multicenter Randomized Study for Medico-economic Evaluation of Embolization With Flow Diverter Stent in the Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Intracranial Aneurysm
  • Device: PIPELINE flow diverter stent
    endovascular procedure using the medical device PIPELINE
  • Device: Coils, with or without expendable stent
    endovascular embolization procedure using microspires, with the possibility of using a balloon temporary and / or implantation of a stent complementary intracranial before implementation of microspires
  • Experimental: PIPELINE flow diverter stent
    flow diverter stent
    Interventions:
    • Device: PIPELINE flow diverter stent
    • Device: Coils, with or without expendable stent
  • Active Comparator: Coils, with or without expendable stent
    Coils
    Interventions:
    • Device: PIPELINE flow diverter stent
    • Device: Coils, with or without expendable stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
November 2017
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient's age ≥ 18 years old
  • Unruptured saccular intracranial aneurysm diagnosed by angiography or CT angiography or MR angiography, located in the intra-dural area, with a neck diameter between 4 and 10 mm, with a sac diameter between 7 mm and 20 mm, with a ratio "dome/nek" greater than 1, and with a diameter of the parent artery between 2 and 5 mm.
  • No prior treatment of the aneurysm
  • Agreement for participating in the study and informed consent signed by the patient
  • Patient affiliated to a social security scheme

Exclusion Criteria:

  • Patient's age < 18 years old
  • Adult patient protected by law
  • Contraindications to the endovascular procedure
  • Contraindications to antiplatelet or anticoagulant treatment
  • Prior treatment of the aneurysm
  • Presence of an arteriovenous malformation
  • Extradural location of the aneurysm
  • Fusiform aneurysm
  • Active bacterial infection (clinical signs)
  • Intracranial hemorrhage from aneurysm in the previous month
  • Pregnant or breastfeeding woman
Both
18 Years and older
No
Contact: Francis Turjman, PH 33 4.72.35.74.05 francis.turjman@chu-lyon.fr
Contact: Erica Gaspak 33 4.72.11.54.38 erica.gaspak@chu-lyon.fr
France
 
NCT01811134
2011.689
Yes
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: Francis TURJMAN, PH Hospices Civils de Lyon
Hospices Civils de Lyon
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP