PRET: Patients Prone to Recurrence After Endovascular Treatment

Phase 4

Completed

Conditions: Subarachnoid Hemorrhage
Intracranial Aneurysm

Interventions: Procedure: endovascular coil embolization

Registration Number: NCT00626912

Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 447

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	endovascular coil embolization	platinum coils
2	endovascular coil embolization	hydrogel coils

Primary Outcome Measures

Name	Time	Method
Recurrence Rate of Target Aneurysm.	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Events	18 months	Number of participants having experienced one or several Serious Adverse Events
Number of Participants With Adverse Events	18 months	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.
Mortality Rate	18 months	Number of participants dead - All causes

Trial Locations

Locations (32): SUNY Upstate Medical University
🇺🇸
Syracuse, New York, United States
The Walton Centre NHS Foundation Trust
🇬🇧
Liverpool, United Kingdom
Borgess Medical Center
🇺🇸
Kalamazoo, Michigan, United States
CHU de Nantes - Hôpital Guillaume et René Laennec
🇫🇷
Nantes, France
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Queens Medical Centre
🇬🇧
Nottingham,, United Kingdom
CHU de Montpellier - Hôpital Gui de Chauliac
🇫🇷
Montpellier, France
The Ottawa Hospital
🇨🇦
Ottawa, Ontario, Canada
Leeds General Infirmary
🇬🇧
Leeds, United Kingdom
West Virginia University Hospital
🇺🇸
Morgantown, West Virginia, United States
CHU Bordeaux - Hôpital Pellegrin
🇫🇷
Bordeaux, France
University of Wisconsin Hospital and Clinics
🇺🇸
Madison, Wisconsin, United States
University of Cincinnati Medical Center
🇺🇸
Cincinnati, Ohio, United States
The Methodist Hospital
🇺🇸
Houston, Texas, United States
Saint Francis Medical Center
🇺🇸
Cape Girardeau, Missouri, United States
University of Mississipi Health Care
🇺🇸
Jackson, Mississippi, United States
University of Buffalo (SUNY)
🇺🇸
Buffalo, New York, United States
Washington University in St Louis
🇺🇸
Saint Louis, Missouri, United States
Stony Brook University Medical Center (SUNY)
🇺🇸
Stony Brook, New York, United States
University of Oklahoma Health Sciences Center
🇺🇸
Oklahoma City, Oklahoma, United States
CHU Henri Mondor - Hôpital Henri Mondor
🇫🇷
Creteil, France
CHU Nancy-Hôpital Central
🇫🇷
Nancy, France
Centre Hospitalier Sainte Anne
🇫🇷
Paris, France
University of Alberta Hospital
🇨🇦
Edmonton, Alberta, Canada
Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital
🇨🇦
Montréal, Quebec, Canada
Kobe City Medical Center General Hospital
🇯🇵
Kobe, Japan
Instituto de Neurocirugía Dr. Asenjo
🇨🇱
Santiago, Chile
Mayo Clinic Rochester
🇺🇸
Rochester, Minnesota, United States
Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
University of Virginia Health System
🇺🇸
Charlottesville, Virginia, United States
Shands - University of Florida Hospital
🇺🇸
Gainesville, Florida, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States