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

Primary Purpose

Intracranial Aneurysm, Subarachnoid Hemorrhage

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
endovascular coil embolization
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring large aneurysm, recurrence, hydrocoil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shands - University of Florida Hospital
  • Borgess Medical Center
  • Mayo Clinic Rochester
  • University of Mississipi Health Care
  • Saint Francis Medical Center
  • Washington University in St Louis
  • University of Buffalo (SUNY)
  • Stony Brook University Medical Center (SUNY)
  • SUNY Upstate Medical University
  • University of Cincinnati Medical Center
  • Cleveland Clinic
  • University of Oklahoma Health Sciences Center
  • Oregon Health and Science University
  • Medical University of South Carolina
  • The Methodist Hospital
  • University of Virginia Health System
  • West Virginia University Hospital
  • University of Wisconsin Hospital and Clinics
  • University of Alberta Hospital
  • The Ottawa Hospital
  • Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital
  • Instituto de Neurocirugía Dr. Asenjo
  • CHU Bordeaux - Hôpital Pellegrin
  • CHU Henri Mondor - Hôpital Henri Mondor
  • CHU de Montpellier - Hôpital Gui de Chauliac
  • CHU Nancy-Hôpital Central
  • CHU de Nantes - Hôpital Guillaume et René Laennec
  • Centre Hospitalier Sainte Anne
  • Kobe City Medical Center General Hospital
  • Leeds General Infirmary
  • The Walton Centre NHS Foundation Trust
  • Queens Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

platinum coils

hydrogel coils

Outcomes

Primary Outcome Measures

Recurrence Rate of Target Aneurysm.
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; retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period; 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.

Secondary Outcome Measures

Mortality Rate
Number of participants dead - All causes
Number of Participants With Adverse Events
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.
Number of Participants With Serious Adverse Events
Number of participants having experienced one or several Serious Adverse Events

Full Information

First Posted
February 21, 2008
Last Updated
March 12, 2019
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT00626912
Brief Title
PRET: Patients Prone to Recurrence After Endovascular Treatment
Acronym
PRET
Official Title
PRET: Patients Prone to Recurrence After Endovascular Treatment. A Randomized Trial Comparing Platinum and Hydrogel-coated Coils
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm, Subarachnoid Hemorrhage
Keywords
large aneurysm, recurrence, hydrocoil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
447 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
platinum coils
Arm Title
2
Arm Type
Active Comparator
Arm Description
hydrogel coils
Intervention Type
Procedure
Intervention Name(s)
endovascular coil embolization
Other Intervention Name(s)
platinum coil, hydrogel coil
Intervention Description
standard endovascular coil embolization with or without adjunct techniques
Primary Outcome Measure Information:
Title
Recurrence Rate of Target Aneurysm.
Description
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; retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period; 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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Mortality Rate
Description
Number of participants dead - All causes
Time Frame
18 months
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
18 months
Title
Number of Participants With Serious Adverse Events
Description
Number of participants having experienced one or several Serious Adverse Events
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean RAYMOND, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Daniel ROY, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Study Director
Facility Information:
Facility Name
Shands - University of Florida Hospital
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
University of Mississipi Health Care
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
Country
United States
Facility Name
Washington University in St Louis
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
University of Buffalo (SUNY)
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Stony Brook University Medical Center (SUNY)
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Instituto de Neurocirugía Dr. Asenjo
City
Santiago
Country
Chile
Facility Name
CHU Bordeaux - Hôpital Pellegrin
City
Bordeaux
Country
France
Facility Name
CHU Henri Mondor - Hôpital Henri Mondor
City
Creteil
Country
France
Facility Name
CHU de Montpellier - Hôpital Gui de Chauliac
City
Montpellier
Country
France
Facility Name
CHU Nancy-Hôpital Central
City
Nancy
Country
France
Facility Name
CHU de Nantes - Hôpital Guillaume et René Laennec
City
Nantes
Country
France
Facility Name
Centre Hospitalier Sainte Anne
City
Paris
Country
France
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
Country
Japan
Facility Name
Leeds General Infirmary
City
Leeds
Country
United Kingdom
Facility Name
The Walton Centre NHS Foundation Trust
City
Liverpool
Country
United Kingdom
Facility Name
Queens Medical Centre
City
Nottingham,
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24849854
Citation
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.
Results Reference
derived
Links:
URL
http://www.iconetwork.org
Description
Related Info

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