The PRET study aims at comparing two types of coils used in the endovascular treatment of intracranial aneurysms. The first type made of platinum has been used for more than 15 years. The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET study is that the newer hydrocoil will be more effective and yet as safe as the older platinum coil.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
447
standard endovascular coil embolization with or without adjunct techniques
Recurrence Rate of Target Aneurysm.
1. major angiographic recurrence of the lesion or the presence of a residual aneurysm at last angiographic follow-up, as determined by the core laboratory, blinded to treatment allocation; 2. retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period; 3. an intracranial bleeding episode, or the occurrence or progression of a mass effect in relation to the treated aneurysm during the follow-up period, as determined by the blinded Adverse Event Committee.
Time frame: 18 months
Mortality Rate
Number of participants dead - All causes
Time frame: 18 months
Number of Participants With Adverse Events
Number of participants having experienced one or several Adverse Events. This measure is the number of participants having experienced Serious Adverse Events plus those having experienced other (not including Serious) Adverse Events.
Time frame: 18 months
Number of Participants With Serious Adverse Events
Number of participants having experienced one or several Serious Adverse Events
Time frame: 18 months
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