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Stenting in the Treatment of Aneurysm Trial

NCT01340612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2023-07-06

No results posted yet for this study

Summary

The STAT trial aims at comparing coiling versus coiling plus stenting in patients with aneurysms prone to recurrence, that is large aneurysms or recurring aneurysms after previous coiling or wide-necked aneurysms. The primary hypothesis is that the use of stenting in addition to coiling decreases the recurrence rate from 33% to 20% at 12 months as compared to coiling alone.

Conditions

  • Intracranial Aneurysm

Interventions

DEVICE

endovascular coiling with any type of currently approved coil (first or second generation)

Standard procedure for endovascular coiling.Coils may be bare Platinum coils or any so-called second generation coils such as but not restricted to Hydrocoil or Cerecyte

DEVICE

endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.

Standard procedure for stenting. Addition of coils to the stent is left to the judgment of the treating physician

Sponsors & Collaborators

  • University Hospital, Brest

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Jean Raymond, MD · Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-25
Primary Completion
2023-01-31
Completion
2023-04-30

Countries

  • Canada
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01340612 on ClinicalTrials.gov