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

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: PIPELINE flow diverter stent; Device: Coils, with or without expendable stent

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.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • BRON
    • Lyon, BRON, France
      • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PIPELINE flow diverter stent; flow diverter stent	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
Active Comparator: Coils, with or without expendable stent; Coils	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Occurrence of a non-cerebral bleeding		24 months
Rate of patients with neurological deficits by mass effect		hospitalization for the endovascular procedure, an expected average of 1 hour; 3 months, 6 months and 12 months post-intervention
Retreatment of the aneurysm		24 months
Rate of technical complications		Endovascular procedure an expected average of 1 hour
Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others		Endovascular procedure an expected average of 1 hour
Rate of correct placement of flow diverter stents, according to the investigator		Endovascular procedure an expected average of 1 hour
mean duration of irradiation related to angiography		Endovascular procedure an expected average of 1 hour
Rate of patients for each class of occlusion	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	Endovascular procedure , an expected average of 1 hour and 12 months
Modified Rankin score		Inclusion, 3 months and 12 months
National Institute of Health Stroke Score (NIHSS)		Inclusion, 3 months and 12 months
Evolution of the Barthel index		: Inclusion and 12 months
Incremental cost-effectiveness ratio		12 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Francis TURJMAN, PH, Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (Estimated): March 14, 2013

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: endovascular procedure; flow diverter stent
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 2011.689; 2011-A01079-32 (Other Identifier: IDRCB)