PRET: Patients Prone to Recurrence After Endovascular Treatment

This study is currently recruiting participants.

Verified by Centre hospitalier de l'Université de Montréal (CHUM), September 2008

Sponsored by:	Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by:	Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:	NCT00626912

Purpose

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.

Condition	Intervention	Phase
Intracranial Aneurysm Subarachnoid Hemorrhage	Procedure: endovascular coil embolization	Phase IV

MedlinePlus related topics: Aneurysms

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	PRET: Patients Prone to Recurrence After Endovascular Treatment. A Randomized Trial Comparing Platinum and Hydrogel-Coated Coils

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:

Recurrence rate of target aneurysm. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety data (mortality rate, number of adverse events, and severity of adverse events) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator platinum coils	Procedure: endovascular coil embolization standard endovascular coil embolization with or without adjunct techniques
2: Active Comparator hydrogel coils	Procedure: endovascular coil embolization standard endovascular coil embolization with or without adjunct techniques

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626912

Contacts

Contact: Ruby Klink, PhD	1-514-890-8000 ext 25245	ruby.klink@crchum.qc.ca
Contact: Marcia Loor	1-514-890-8000 ext 27206	marcia.loor.chum@ssss.gouv.qc.ca

Locations

Canada, Quebec
Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital	Recruiting
Montréal, Quebec, Canada, H2L 4M1
Contact: Ruby Klink, PhD 514-890-8000 ext 25245 ruby.klink@crchum.qc.ca
Principal Investigator: Daniel Roy, MD

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

Study Chair:	Jean RAYMOND, MD	Centre hospitalier de l'Université de Montréal
Study Director:	Daniel ROY, MD	Centre hospitalier de l'Université de Montréal

More Information

Study website This link exits the ClinicalTrials.gov site

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Centre hospitalier de l'Université de Montréal ( Jean Raymond, MD )
Study ID Numbers:	ND07.001
Study First Received:	February 21, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00626912
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):

large aneurysm
recurrence
hydrocoil

Study placed in the following topic categories:

Intracranial Aneurysm
Aneurysm
Vascular Diseases
Subarachnoid Hemorrhage
Central Nervous System Diseases
Intracranial Hemorrhages

Brain Diseases
Hemorrhage
Cerebrovascular Disorders
Intracranial Arterial Diseases
Recurrence

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009