Overview

This trial is active, not recruiting.

Conditions intracranial aneurysm, subarachnoid hemorrhage
Treatment endovascular coil embolization
Phase phase 4
Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Start date June 2007
End date October 2015
Trial size 500 participants
Trial identifier NCT00626912, ND07.001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
platinum coils
endovascular coil embolization platinum coil
standard endovascular coil embolization with or without adjunct techniques
(Active Comparator)
hydrogel coils
endovascular coil embolization platinum coil
standard endovascular coil embolization with or without adjunct techniques

Primary Outcomes

Measure
Recurrence rate of target aneurysm.
time frame: 18 months

Secondary Outcomes

Measure
safety data (mortality rate, number of adverse events, and severity of adverse events)
time frame: 18 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title PRET: Patients Prone to Recurrence After Endovascular Treatment. A Randomized Trial Comparing Platinum and Hydrogel-coated Coils
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM).