PRET: Patients Prone to Recurrence After Endovascular Treatment - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Brain Aneurysm

U.S. FDA Resources

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: Assia Bellblidia, MD	1-514-890-8000 ext 34369	assia.belblidia.chum@ssss.gouv.qc.ca

Locations

United States, Florida
Shands - University of Florida Hospital	Recruiting
Gainesville, Florida, United States
Contact: Adrienne Royster royster@neurosurgery.ufl.edu
Principal Investigator: J. Dufy Mocco, MD
United States, Michigan
Borgess Medical Center	Recruiting
Kalamazoo,, Michigan, United States
Contact: Sarah Walker SarahWalker@borgess.com
Principal Investigator: Firas Al-Ali, MD
United States, Minnesota
Mayo Clinic Rochester	Recruiting
Rochester, Minnesota, United States
Contact: Leigh Gray Gray.Leigh@mayo.edu
Principal Investigator: David Kallmes, MD
United States, New York
Stony Brook University Medical Center (SUNY)	Recruiting
Stony Brook, New York, United States
Contact: Susan Fiore sfiore@notes.cc.sunysb.edu
Principal Investigator: Henry Woo, Woo
Columbia University Medical Center	Recruiting
New York, New York, United States
Contact: Virginia Cox vc94@columbia.edu
Principal Investigator: Sean Lavine, MD
University of Buffalo (SUNY)	Recruiting
Buffalo, New York, United States
Contact: Annemarie Crumlish AMCrumlish@buffns.com
Principal Investigator: Elad Levy, MD
United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States
Contact: Doreen Andrews-Hinders ANDREWD@ccf.org
Principal Investigator: Thomas Masaryk, MD
United States, Oregon
Oregon Health and Science University	Recruiting
Portland, Oregon, United States
Contact: Sarah Ross rosssar@ohsu.edu
Principal Investigator: Stanley Barnwell, MD
United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States
Contact: Adrian Parker parkerad@musc.edu
Principal Investigator: Aquilla Turk, Dr
United States, Texas
The Methodist Hospital	Recruiting
Houston, Texas, United States
Contact: Marilyn Bautista mhbautista@tmhs.org
Principal Investigator: Richard Klucznick, Dr
United States, Virginia
University of Virginia Health System	Recruiting
Charlottesville,, Virginia, United States
Contact: Claire McKinley CW9NE@hscmail.mcc.virginia.edu
Principal Investigator: Avery Evans, MD
Canada, Ontario
The Ottawa Hospital	Recruiting
Ottawa, Ontario, Canada
Contact: Betty Anne Schwarz baschwarz@Ottawahospital.on.ca
Principal Investigator: Marlise Santos, MD
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
Chile
Instituto de Neurocirugía Dr. Asenjo	Recruiting
Santiago, Chile
Contact: Juan Gabriel Sordo Jara jgsordo@gmail.com
Principal Investigator: Eduardo Bravo, MD
Sub-Investigator: Juan Gabriel Sordo Jara, MD
France
CHU Nancy-Hôpital Central	Recruiting
Nancy, France
Contact: Serge Bracard s.bracard@chu-nancy.fr
Principal Investigator: Serge Bracard, MD
Japan
Kobe City Medical Center General Hospital	Recruiting
Kobe, Japan
Contact: Nobuyuki Sakai, MD n.sakai@siren.ocn.ne.jp
Principal Investigator: Nobuyuki Sakai, MD
United Kingdom
Leeds General Infirmary	Recruiting
Leeds, United Kingdom
Contact: Anthony Goddard Tony.Goddard@leedsth.nhs.uk
Principal Investigator: Anthony Goddard, 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

Additional Information:

Study website This link exits the ClinicalTrials.gov site

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00626912 History of Changes
Health Authority:	Canada: Ethics Review Committee

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

large aneurysm
recurrence
hydrocoil

Additional relevant MeSH terms:

Disease Attributes
Aneurysm
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Intracranial Hemorrhages
Hemorrhage
Brain Diseases

Intracranial Arterial Diseases
Cerebrovascular Disorders
Recurrence
Intracranial Aneurysm
Pathologic Processes
Subarachnoid Hemorrhage
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010