PRET: Patients Prone to Recurrence After Endovascular Treatment

Study Overview
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Brief Summary
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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.

Official Title
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PRET: Patients Prone to Recurrence After Endovascular Treatment. A Randomized Trial Comparing Platinum and Hydrogel-coated Coils

Conditions
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Intracranial Aneurysm, Subarachnoid Hemorrhage

Intervention / Treatment
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* Procedure: endovascular coil embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients presenting at least one aneurysm 'prone to recurrence after endovascular treatment' (PRET), defined for the sake of this study as: PRET-1: One ruptured or unruptured aneurysm, never treated, with a dimension ≥10mm (longest axis, including thrombosed portions of large or giant aneurysms); for ruptured lesions, patients should be in WFNS grade I, II or III. PRET-2: an Aneurysm presenting a major recurrence after previous coiling; and judged by the neurovascular team to require elective treatment. The anatomy of the lesion is such that endovascular treatment is possible with both types of coils (not necessarily certain or probable) The endovascular physician is content to use either type of coils (platinum or hydrogel-coated coils) but no other type of coils Patient is 18 or older Life expectancy is more than 2 years Exclusion Criteria: Presence of other aneurysms requiring treatment during the same session Patients with associated cerebral arteriovenous malformations When parent vessel occlusion, without simultaneous endosaccular coiling of the aneurysm, is the primary intent of the procedure Any absolute contraindication to endovascular treatment, angiography, or anaesthesia such as severe allergies to contrast or medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>platinum coils | Procedure: endovascular coil embolization<br>* standard endovascular coil embolization with or without adjunct techniques<br>* Other names: hydrogel coil;|
| Active Comparator: 2<br>hydrogel coils | Procedure: endovascular coil embolization<br>* standard endovascular coil embolization with or without adjunct techniques<br>* Other names: hydrogel coil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Rate of Target Aneurysm. | 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; retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period; 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate | Number of participants dead - All causes | 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. | 18 months | 
| Number of Participants With Serious Adverse Events | Number of participants having experienced one or several Serious Adverse Events | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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large aneurysm, recurrence, hydrocoil