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PRET: Patients Prone to Recurrence After Endovascular Treatment

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

NCT00626912•Centre hospitalier de l'Université de Montréal (CHUM)

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (32)

Shands - University of Florida Hospital

Gainesville, Florida, United States

Borgess Medical Center

Kalamazoo, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

University of Mississipi Health Care

Jackson, Mississippi, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Washington University in St Louis

St Louis, Missouri, United States

University of Buffalo (SUNY)

Buffalo, New York, United States

Stony Brook University Medical Center (SUNY)

Stony Brook, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

June 1, 2007

Primary Completion Date

October 1, 2015

Completion Date

December 1, 2015

Last Updated

March 26, 2019

Enrollment

447

ACTUAL participants

Conditions

Intracranial AneurysmSubarachnoid Hemorrhage

Interventions

endovascular coil embolization

PROCEDURE

Targeting Real World Usage In Stroke Treatment

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Saccular and Fusiform AneurysmsPseudoaneurysm+7 more

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RECRUITING

Product Surveillance Registry

NCT01524276

Cardiac Rhythm DisordersUrological Disorders+14 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PRET: Patients Prone to Recurrence After Endovascular Treatment

Inclusion Criteria

Exclusion Criteria

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