PRET: Patients Prone to Recurrence After Endovascular Treatment
This study is currently recruiting participants.
Verified February 2013 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT00626912
First received: February 21, 2008
Last updated: February 26, 2013
Last verified: February 2013
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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: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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:
|
|
Active Comparator: 2
hydrogel coils
|
Procedure: endovascular coil embolization
standard endovascular coil embolization with or without adjunct techniques
Other Names:
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626912
Show 32 Study Locations
Contacts
| Contact: Ruby Klink, PhD | 1-514-890-8000 ext 25245 | ruby.klink@crchum.qc.ca |
| Contact: Assia Bellblidia, MD | 1-514-890-8000 ext 34369 | assia.belblidia.chum@ssss.gouv.qc.ca |
Show 32 Study LocationsSponsors 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
| 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: | February 26, 2013 |
| 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 May 16, 2013