PRET: Patients Prone to Recurrence After Endovascular Treatment

Completed · Phase 4

Conditions studied: Intracranial Aneurysm, Subarachnoid Hemorrhage

In brief

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.

Key facts

Study ID

NCT00626912

Run by

Centre hospitalier de l'Université de Montréal (CHUM)

People needed

447

Starts

2007-06-01

Expected to finish

2015-12-01

Last updated by the study team

2019-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shands - University of Florida Hospital — Gainesville, Florida, United States
• Borgess Medical Center — Kalamazoo, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• University of Mississipi Health Care — Jackson, Mississippi, United States
• Saint Francis Medical Center — Cape Girardeau, Missouri, United States
• Washington University in St Louis — St Louis, Missouri, United States
• University of Buffalo (SUNY) — Buffalo, New York, United States
• Stony Brook University Medical Center (SUNY) — Stony Brook, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• The Methodist Hospital — Houston, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• West Virginia University Hospital — Morgantown, West Virginia, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• University of Alberta Hospital — Edmonton, Alberta, Canada
• The Ottawa Hospital — Ottawa, Ontario, Canada
• Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital — Montreal, Quebec, Canada
• Instituto de Neurocirugía Dr. Asenjo — Santiago, Chile
• CHU Bordeaux - Hôpital Pellegrin — Bordeaux, France
• CHU Henri Mondor - Hôpital Henri Mondor — Créteil, France
• CHU de Montpellier - Hôpital Gui de Chauliac — Montpellier, France

Full record on ClinicalTrials.gov

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