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

NCT ID: NCT01811134

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2020-03-31

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 Description

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.

Conditions

Intracranial Aneurysm

Keywords

endovascular procedure; flow diverter stent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PIPELINE flow diverter stent

flow diverter stent

Group Type: EXPERIMENTAL

PIPELINE flow diverter stent

Intervention Type: DEVICE

endovascular procedure using the medical device PIPELINE

Coils, with or without expendable stent

Intervention Type: 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

Coils, with or without expendable stent

Coils

Group Type: ACTIVE_COMPARATOR

PIPELINE flow diverter stent

Intervention Type: DEVICE

endovascular procedure using the medical device PIPELINE

Coils, with or without expendable stent

Intervention Type: 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

Interventions

PIPELINE flow diverter stent

endovascular procedure using the medical device PIPELINE

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis TURJMAN, PH

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hospices Civils de Lyon

Lyon, BRON, France

Countries

France

References

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.

Reference Type: RESULT

PMID: 25280445 (View on PubMed)

Other Identifiers

2011-A01079-32

Identifier Type: OTHER

Identifier Source: secondary_id

2011.689

Identifier Type: -

Identifier Source: org_study_id