PRET: Patients Prone to Recurrence After Endovascular Treatment (PRET)

March 12, 2019 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

447

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • Ontario
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital
    • Quebec
      • Montréal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital
  • Chile
      • Santiago, Chile
        • Instituto de Neurocirugía Dr. Asenjo
  • France
      • Bordeaux, France
        • CHU bordeaux - Hopital Pellegrin
      • Creteil, France
        • CHU Henri Mondor - Hôpital Henri Mondor
      • Montpellier, France
        • CHU de Montpellier - Hôpital Gui de Chauliac
      • Nancy, France
        • CHU Nancy-Hôpital Central
      • Nantes, France
        • CHU de Nantes - Hôpital Guillaume et René Laennec
      • Paris, France
        • Centre Hospitalier Sainte Anne
  • Japan
      • Kobe, Japan
        • Kobe City Medical Center General Hospital
  • United Kingdom
      • Leeds, United Kingdom
        • Leeds General Infirmary
      • Liverpool, United Kingdom
        • The Walton Centre NHS Foundation Trust
      • Nottingham,, United Kingdom
        • Queens Medical Centre
  • United States
    • Florida
      • Gainesville, Florida, United States
        • Shands - University of Florida Hospital
    • Michigan
      • Kalamazoo, Michigan, United States
        • Borgess Medical Center
    • Minnesota
      • Rochester, Minnesota, United States
        • Mayo Clinic Rochester
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississipi Health Care
    • Missouri
      • Cape Girardeau, Missouri, United States
        • Saint Francis Medical Center
      • Saint Louis, Missouri, United States
        • Washington University in St Louis
    • New York
      • Buffalo, New York, United States
        • University of Buffalo (SUNY)
      • Stony Brook, New York, United States
        • Stony Brook University Medical Center (SUNY)
      • Syracuse, New York, United States
        • SUNY Upstate Medical University
    • Ohio
      • Cincinnati, Ohio, United States
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States
        • Cleveland Clinic
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health and Science University
    • South Carolina
      • Charleston, South Carolina, United States
        • Medical University of South Carolina
    • Texas
      • Houston, Texas, United States
        • The Methodist Hospital
    • Virginia
      • Charlottesville, Virginia, United States
        • University of Virginia Health System
    • West Virginia
      • Morgantown, West Virginia, United States
        • West Virginia University Hospital
    • Wisconsin
      • Madison, Wisconsin, United States
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
platinum coils
Procedure: endovascular coil embolization
standard endovascular coil embolization with or without adjunct techniques
Other Names:
  • platinum coil
  • hydrogel coil
Active Comparator: 2
hydrogel coils
Procedure: endovascular coil embolization
standard endovascular coil embolization with or without adjunct techniques
Other Names:
  • platinum coil
  • hydrogel coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Rate of Target Aneurysm.
Time Frame: 18 months
  1. 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;
  2. retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period;
  3. 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality Rate
Time Frame: 18 months
Number of participants dead - All causes
18 months
Number of Participants With Adverse Events
Time Frame: 18 months
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
Number of Participants With Serious Adverse Events
Time Frame: 18 months
Number of participants having experienced one or several Serious Adverse Events
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Study Chair: Jean RAYMOND, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)
  • Study Director: Daniel ROY, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 21, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ND07.001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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