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NCT00626912 · ClinicalTrials.gov registry record · Phase 4
PRET: Patients Prone to Recurrence After Endovascular Treatment
A Phase 4 study of Subarachnoid Hemorrhage and Intracranial Aneurysm, sponsored by Centre hospitalier de l'Université de Montréal (CHUM).
- Completed
- Registry status
- Phase 4
- Development phase
- 447
- Enrollment target
- 20
- Study locations
NCT00626912: Completed Phase 4 study of Subarachnoid Hemorrhage and Intracranial Aneurysm, sponsored by Centre hospitalier de l'Université de Montréal (CHUM).
NCT00626912 is a Phase 4 study of Subarachnoid Hemorrhage and Intracranial Aneurysm that has completed, run by Centre hospitalier de l'Université de Montréal (CHUM). The registered enrollment target is 447 participants, below the 3,567-participant average among 21 other Subarachnoid Hemorrhage trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00626912, a Phase 4 study of Subarachnoid Hemorrhage and Intracranial Aneurysm, has completed, sponsored by Centre hospitalier de l'Université de Montréal (CHUM).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 447 participants
- Enrollment target
- 20
- Study locations
Study 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, 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.
Primary Outcome
1. major angiographic recurrence of the lesion or the presence of a residual aneurysm at last angiographic follow-up, as determined by the core laboratory, blinded to treatment allocation; 2. retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period; 3. an intracranial bleeding episode, or the occurrence or progression of a mass effect in relation to the treated aneurysm during the follow-up period, as determined by the blinded Adverse Event Committe
Conditions Studied
Interventions
- PROCEDURE endovascular coil embolization
Study Locations (20)
New York
- University of Buffalo (SUNY) - Buffalo
- Stony Brook University Medical Center (SUNY) - Stony Brook
- SUNY Upstate Medical University - Syracuse
Missouri
- Saint Francis Medical Center - Cape Girardeau
- Washington University in St Louis - St Louis
Ohio
- University of Cincinnati Medical Center - Cincinnati
- Cleveland Clinic - Cleveland
Florida
- Shands - University of Florida Hospital - Gainesville
Michigan
- Borgess Medical Center - Kalamazoo
Minnesota
- Mayo Clinic Rochester - Rochester
Mississippi
- University of Mississipi Health Care - Jackson
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2007-06 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
What the finished NCT00626912 record still lists
NCT00626912 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, below the 3,567-participant average among 21 other Subarachnoid Hemorrhage trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Subarachnoid Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which endovascular coil embolization is the first listed.
NCT00626912 names 20 study sites across 16 states, led by New York, Missouri, Ohio.
Frequently Asked Questions
What is clinical trial NCT00626912 about?
NCT00626912 is a clinical study titled "PRET: Patients Prone to Recurrence After Endovascular Treatment". 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...
What is the current status of trial NCT00626912?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 447 participants. The study started on 2007-06. Estimated completion is 2015-12.
What conditions does trial NCT00626912 study?
This clinical trial studies the following conditions: Subarachnoid Hemorrhage, Intracranial Aneurysm.
What interventions are being tested in trial NCT00626912?
The interventions under investigation include: endovascular coil embolization (PROCEDURE).
Who is sponsoring clinical trial NCT00626912?
This trial is sponsored by Centre hospitalier de l'Université de Montréal (CHUM), which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00626912 being conducted?
This trial has 20 study locations across Florida, Michigan, Minnesota, Mississippi, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00626912's enrollment target sits among peer trials
447 4th of 21 higher than 18 of 21 other Subarachnoid Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Subarachnoid Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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