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

Intracranial Aneurysm Clinical Trial

— 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

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
• 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
• 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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

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