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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
447

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jean RAYMOND, MD, Centre hospitalier de l'Université de Montréal (CHUM)
  • Study Director: Daniel ROY, MD, Centre hospitalier de l'Université de Montréal (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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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