PRET: Patients Prone to Recurrence After Endovascular Treatment

Subarachnoid Hemorrhage Clinical Trial

— PRET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626912
• Other study ID #: ND07.001
• Status: Completed
• Phase: Phase 4
• Start date: June 2007
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Hemorrhage
• Intracranial Aneurysm
• Recurrence
• Subarachnoid Hemorrhage

Intervention

Procedure:
• endovascular coil embolization
standard endovascular coil embolization with or without adjunct techniques

Locations

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

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Canada,  Chile,  France,  Japan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality Rate	Number of participants dead - All causes	18 months
Secondary	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
Secondary	Number of Participants With Serious Adverse Events	Number of participants having experienced one or several Serious Adverse Events	18 months