EVIDENCEMulticenter Randomized Study for Medico-economic Evaluation of Embolization With Flow Diverter Stent in the Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
PIPELINE flow diverter stent
+ Coils, with or without expendable stent
+ PIPELINE flow diverter stent
Aneurysm+6
+ Brain Diseases
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: November 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.91 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location