PRET: Patients Prone to Recurrence After Endovascular Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT00626912
First received: February 21, 2008
Last updated: May 27, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 500
Study Start Date: June 2007
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study Director: Daniel ROY, MD Centre Hospitalier de l'Université de Montréal
  More Information

Additional Information:
No publications provided by Centre hospitalier de l'Université de Montréal (CHUM)

Additional 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
Study First Received: February 21, 2008
Last Updated: May 27, 2014
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on July 28, 2014