PRET: Patients Prone to Recurrence After Endovascular Treatment

NCT ID: NCT00626912

Last Updated: 2019-03-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

447 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intracranial Aneurysm Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

platinum coils

Group Type ACTIVE_COMPARATOR

endovascular coil embolization

Intervention Type PROCEDURE

standard endovascular coil embolization with or without adjunct techniques

2

hydrogel coils

Group Type ACTIVE_COMPARATOR

endovascular coil embolization

Intervention Type PROCEDURE

standard endovascular coil embolization with or without adjunct techniques

Interventions

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endovascular coil embolization

standard endovascular coil embolization with or without adjunct techniques

Intervention Type PROCEDURE

Other Intervention Names

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platinum coil hydrogel coil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean RAYMOND, MD

Role: STUDY_CHAIR

Centre hospitalier de l'Université de Montréal (CHUM)

Daniel ROY, MD

Role: STUDY_DIRECTOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

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Shands - University of Florida Hospital

Gainesville, Florida, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

University of Mississipi Health Care

Jackson, Mississippi, United States

Site Status

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status

Washington University in St Louis

St Louis, Missouri, United States

Site Status

University of Buffalo (SUNY)

Buffalo, New York, United States

Site Status

Stony Brook University Medical Center (SUNY)

Stony Brook, New York, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

The Methodist Hospital

Houston, Texas, United States

Site Status

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

West Virginia University Hospital

Morgantown, West Virginia, United States

Site Status

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital

Montreal, Quebec, Canada

Site Status

Instituto de Neurocirugía Dr. Asenjo

Santiago, , Chile

Site Status

CHU Bordeaux - Hôpital Pellegrin

Bordeaux, , France

Site Status

CHU Henri Mondor - Hôpital Henri Mondor

Créteil, , France

Site Status

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, , France

Site Status

CHU Nancy-Hôpital Central

Nancy, , France

Site Status

CHU de Nantes - Hôpital Guillaume et René Laennec

Nantes, , France

Site Status

Centre Hospitalier Sainte Anne

Paris, , France

Site Status

Kobe City Medical Center General Hospital

Kobe, , Japan

Site Status

Leeds General Infirmary

Leeds, , United Kingdom

Site Status

The Walton Centre NHS Foundation Trust

Liverpool, , United Kingdom

Site Status

Queens Medical Centre

Nottingham, , United Kingdom

Site Status

Countries

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United States Canada Chile France Japan United Kingdom

References

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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.

Reference Type DERIVED
PMID: 24849854 (View on PubMed)

Other Identifiers

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ND07.001

Identifier Type: -

Identifier Source: org_study_id

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