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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00626912
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : March 1, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Subarachnoid Hemorrhage Procedure: endovascular coil embolization Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 447 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRET: Patients Prone to Recurrence After Endovascular Treatment. A Randomized Trial Comparing Platinum and Hydrogel-coated Coils
Study Start Date : June 2007
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mortality Rate [ Time Frame: 18 months ]
    Number of participants dead - All causes

  2. 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.

  3. Number of Participants With Serious Adverse Events [ Time Frame: 18 months ]
    Number of participants having experienced one or several Serious Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626912


Locations
Show Show 32 study locations
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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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)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT00626912    
Other Study ID Numbers: ND07.001
First Posted: February 29, 2008    Key Record Dates
Results First Posted: March 1, 2019
Last Update Posted: March 26, 2019
Last Verified: July 2016
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
large aneurysm
recurrence
hydrocoil
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Intracranial Aneurysm
Aneurysm
Hemorrhage
Recurrence
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases