NCT01811134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

November 20, 2012

Last Update Submit

December 13, 2025

Conditions

Intracranial Aneurysm

Keywords

endovascular procedure; flow diverter stent

Outcome Measures

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.

    12 months

Secondary Outcomes (17)

  • Occurrence of a death during or after endovascular procedure

    hospitalization for the endovascular procedure, up to 7 days

  • Occurrence of a death whatever the cause

    24 months

  • Occurrence of a death due to aneurysm rupture

    24 months

  • Occurrence of an intracranial hemorrhagic from rupture of the aneurysm

    24 months

  • Occurrence of an ischemic stroke due to thrombosis

    24 months

  • +12 more secondary outcomes

Study Arms (2)

PIPELINE flow diverter stent

EXPERIMENTAL

flow diverter stent

Device: PIPELINE flow diverter stentDevice: Coils, with or without expendable stent

Coils, with or without expendable stent

ACTIVE COMPARATOR

Coils

Device: PIPELINE flow diverter stentDevice: Coils, with or without expendable stent

Interventions

Coils, with or without expendable stentDEVICE

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

Coils, with or without expendable stentPIPELINE flow diverter stent
PIPELINE flow diverter stentDEVICE

endovascular procedure using the medical device PIPELINE

Coils, with or without expendable stentPIPELINE flow diverter stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, BRON, France

Location

Related Publications (1)

  • Turjman F, Levrier O, Combaz X, Bonafe A, Biondi A, Desal H, Bracard S, Mounayer C, Riva R, Chapuis F, Huot L, Armoiry X, Gory B. EVIDENCE trial: design of a phase 2, randomized, controlled, multicenter study comparing flow diversion and traditional endovascular strategy in unruptured saccular wide-necked intracranial aneurysms. Neuroradiology. 2015 Jan;57(1):49-54. doi: 10.1007/s00234-014-1439-7. Epub 2014 Oct 4.

    PMID: 25280445RESULT

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Francis TURJMAN, PH

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2012

First Posted

March 14, 2013

Study Start

November 1, 2012

Primary Completion

November 1, 2015

Study Completion

March 1, 2020

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

FR(1)