Clinical trial NCT00626912: PRET: Patients Prone to Recurrence After Endovascular Treatment
Official title: PRET: Patients Prone to Recurrence After Endovascular Treatment. A Randomized Trial Comparing Platinum and Hydrogel-coated Coils
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intracranial Aneurysm
Subarachnoid Hemorrhage
Keywords: large aneurysm
recurrence
hydrocoil
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence Rate of Target Aneurysm.
timeFrame: 18 months
Secondary outcomes:
measure: Mortality Rate
timeFrame: 18 months
measure: Number of Participants With Adverse Events
timeFrame: 18 months
measure: Number of Participants With Serious Adverse Events
timeFrame: 18 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands - University of Florida Hospital
state: Florida
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Jackson
country: United States
facility: University of Mississipi Health Care
state: Mississippi
city: Cape Girardeau
country: United States
facility: Saint Francis Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St Louis
state: Missouri
city: Buffalo
country: United States
facility: University of Buffalo (SUNY)
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center (SUNY)
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital
state: Quebec
city: Santiago
country: Chile
facility: Instituto de Neurocirugía Dr. Asenjo
city: Bordeaux
country: France
facility: CHU Bordeaux - Hôpital Pellegrin
city: Creteil
country: France
facility: CHU Henri Mondor - Hôpital Henri Mondor
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Gui de Chauliac
city: Nancy
country: France
facility: CHU Nancy-Hôpital Central
city: Nantes
country: France
facility: CHU de Nantes - Hôpital Guillaume et René Laennec
city: Paris
country: France
facility: Centre Hospitalier Sainte Anne
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Liverpool
country: United Kingdom
facility: The Walton Centre NHS Foundation Trust
city: Nottingham,
country: United Kingdom
facility: Queens Medical Centre
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Jean RAYMOND, MD
role: STUDY_CHAIR
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Daniel ROY, MD
role: STUDY_DIRECTOR
References:
citation: Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2. No abstract available.