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

Civil Hospices of Lyon

Status: Completed

Conditions: Intracranial Aneurysm

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01811134

2011.689

2011-A01079-32 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

PIPELINE flow diverter stent

Experimental group

Description:

flow diverter stent

Treatment:

Device: PIPELINE flow diverter stent

Device: Coils, with or without expendable stent

Coils, with or without expendable stent

Active Comparator group

Description:

Coils

Treatment:

Device: PIPELINE flow diverter stent

Device: Coils, with or without expendable stent