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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01811134
Other study ID # 2011.689
Secondary ID 2011-A01079-32
Status Completed
Phase N/A
First received
Last updated
Start date November 2012
Est. completion date March 2020

Study information

Verified date April 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date March 2020
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
PIPELINE flow diverter stent
endovascular procedure using the medical device PIPELINE
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

Locations

Country Name City State
France Hospices Civils de Lyon Lyon Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Occurrence of a death during or after endovascular procedure hospitalization for the endovascular procedure, up to 7 days
Secondary Occurrence of a death whatever the cause 24 months
Secondary Occurrence of a death due to aneurysm rupture 24 months
Secondary Occurrence of an intracranial hemorrhagic from rupture of the aneurysm 24 months
Secondary Occurrence of an ischemic stroke due to thrombosis 24 months
Secondary Occurrence of a non-cerebral bleeding 24 months
Secondary 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
Secondary Retreatment of the aneurysm 24 months
Secondary Rate of technical complications Endovascular procedure an expected average of 1 hour
Secondary Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others Endovascular procedure an expected average of 1 hour
Secondary Rate of correct placement of flow diverter stents, according to the investigator Endovascular procedure an expected average of 1 hour
Secondary mean duration of irradiation related to angiography Endovascular procedure an expected average of 1 hour
Secondary 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
Secondary Modified Rankin score Inclusion, 3 months and 12 months
Secondary National Institute of Health Stroke Score (NIHSS) Inclusion, 3 months and 12 months
Secondary Evolution of the Barthel index : Inclusion and 12 months
Secondary Incremental cost-effectiveness ratio 12 months
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