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

Primary Purpose

Intracranial Aneurysm

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PIPELINE flow diverter stent
Coils, with or without expendable stent
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring endovascular procedure; flow diverter stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PIPELINE flow diverter stent

Coils, with or without expendable stent

Arm Description

flow diverter stent

Coils

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Occurrence of a death during or after endovascular procedure
Occurrence of a death whatever the cause
Occurrence of a death due to aneurysm rupture
Occurrence of an intracranial hemorrhagic from rupture of the aneurysm
Occurrence of an ischemic stroke due to thrombosis
Occurrence of a non-cerebral bleeding
Rate of patients with neurological deficits by mass effect
Retreatment of the aneurysm
Rate of technical complications
Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others
Rate of correct placement of flow diverter stents, according to the investigator
mean duration of irradiation related to angiography
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
Modified Rankin score
National Institute of Health Stroke Score (NIHSS)
Evolution of the Barthel index
Incremental cost-effectiveness ratio

Full Information

First Posted
November 20, 2012
Last Updated
April 28, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01811134
Brief Title
Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
Acronym
EVIDENCE
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
Keywords
endovascular procedure; flow diverter stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PIPELINE flow diverter stent
Arm Type
Experimental
Arm Description
flow diverter stent
Arm Title
Coils, with or without expendable stent
Arm Type
Active Comparator
Arm Description
Coils
Intervention Type
Device
Intervention Name(s)
PIPELINE flow diverter stent
Intervention Description
endovascular procedure using the medical device PIPELINE
Intervention Type
Device
Intervention Name(s)
Coils, with or without expendable stent
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Occurrence of a death during or after endovascular procedure
Time Frame
hospitalization for the endovascular procedure, up to 7 days
Title
Occurrence of a death whatever the cause
Time Frame
24 months
Title
Occurrence of a death due to aneurysm rupture
Time Frame
24 months
Title
Occurrence of an intracranial hemorrhagic from rupture of the aneurysm
Time Frame
24 months
Title
Occurrence of an ischemic stroke due to thrombosis
Time Frame
24 months
Title
Occurrence of a non-cerebral bleeding
Time Frame
24 months
Title
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
Title
Retreatment of the aneurysm
Time Frame
24 months
Title
Rate of technical complications
Time Frame
Endovascular procedure an expected average of 1 hour
Title
Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others
Time Frame
Endovascular procedure an expected average of 1 hour
Title
Rate of correct placement of flow diverter stents, according to the investigator
Time Frame
Endovascular procedure an expected average of 1 hour
Title
mean duration of irradiation related to angiography
Time Frame
Endovascular procedure an expected average of 1 hour
Title
Rate of patients for each class of occlusion
Description
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
Time Frame
Endovascular procedure , an expected average of 1 hour and 12 months
Title
Modified Rankin score
Time Frame
Inclusion, 3 months and 12 months
Title
National Institute of Health Stroke Score (NIHSS)
Time Frame
Inclusion, 3 months and 12 months
Title
Evolution of the Barthel index
Time Frame
: Inclusion and 12 months
Title
Incremental cost-effectiveness ratio
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis TURJMAN, PH
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
State/Province
Bron
Country
France

12. IPD Sharing Statement

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

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