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Completed

NCT Number: NCT01811134

Flow Diverter Stent for 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.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Lyon, BRON, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PIPELINE flow diverter stent

Device

endovascular procedure using the medical device PIPELINE

Coils, with or without expendable stent

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Occurrence of a death during or after endovascular procedure

    Time frame: hospitalization for the endovascular procedure, up to 7 days

  2. Occurrence of a death whatever the cause

    Time frame: 24 months

  3. Occurrence of a death due to aneurysm rupture

    Time frame: 24 months

  4. Occurrence of an intracranial hemorrhagic from rupture of the aneurysm

    Time frame: 24 months

  5. Occurrence of an ischemic stroke due to thrombosis

    Time frame: 24 months

  6. Occurrence of a non-cerebral bleeding

    Time frame: 24 months

  7. 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

  8. Retreatment of the aneurysm

    Time frame: 24 months

  9. Rate of technical complications

    Time frame: Endovascular procedure an expected average of 1 hour

  10. Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others

    Time frame: Endovascular procedure an expected average of 1 hour

  11. Rate of correct placement of flow diverter stents, according to the investigator

    Time frame: Endovascular procedure an expected average of 1 hour

  12. mean duration of irradiation related to angiography

    Time frame: Endovascular procedure an expected average of 1 hour

  13. 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

  14. Modified Rankin score

    Time frame: Inclusion, 3 months and 12 months

  15. National Institute of Health Stroke Score (NIHSS)

    Time frame: Inclusion, 3 months and 12 months

  16. Evolution of the Barthel index

    Time frame: : Inclusion and 12 months

  17. Incremental cost-effectiveness ratio

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: EVIDENCE

Important dates

Study start
2012
Primary completion
2015
Study completion
2020
First posted
Mar 14, 2013
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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