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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00626912
First Posted: February 29, 2008
Last Update Posted: August 5, 2016
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.
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
  Purpose
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 Intervention Phase
Intracranial Aneurysm Subarachnoid Hemorrhage Procedure: endovascular coil embolization Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Recurrence rate of target aneurysm. [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • safety data (mortality rate, number of adverse events, and severity of adverse events) [ Time Frame: 18 months ]

Enrollment: 447
Study Start Date: June 2007
Study Completion Date: December 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


  Show 32 Study Locations
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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)
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT00626912     History of Changes
Other Study ID Numbers: ND07.001
First Submitted: February 21, 2008
First Posted: February 29, 2008
Last Update Posted: August 5, 2016
Last Verified: July 2016

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
large aneurysm
recurrence
hydrocoil

Additional relevant MeSH terms:
Hemorrhage
Aneurysm
Recurrence
Subarachnoid Hemorrhage
Intracranial Aneurysm
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases