Status:
COMPLETED
PRET: Patients Prone to Recurrence After Endovascular Treatment
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Intracranial Aneurysm
Subarachnoid Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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, refer...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT00626912
Start Date
June 1 2007
End Date
December 1 2015
Last Update
March 26 2019
Active Locations (32)
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1
Shands - University of Florida Hospital
Gainesville, Florida, United States
2
Borgess Medical Center
Kalamazoo, Michigan, United States
3
Mayo Clinic Rochester
Rochester, Minnesota, United States
4
University of Mississipi Health Care
Jackson, Mississippi, United States, 39216