International Subarachnoid Aneurysm Trial II
The purpose of this study is to compare the clinical outcome of surgical clipping and endovascular coiling for ruptured intracranial aneurysms not included in the original ISAT Study.
Conditions:
🦠 Intracranial Hemorrhage Ruptured Aneurysm
🗓️ Study Start (Actual) 12 November 2012
🗓️ Primary Completion (Estimated) December 2023
✅ Study Completion (Estimated) June 2024
👥 Enrollment (Estimated) 1724
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Bronx, New York, United States
📍 Calgary, Alberta, Canada
📍 Edmonton, Alberta, Canada
📍 Montreal, Quebec, Canada
📍 Barcelona, Spain
📍 Valladolid, Spain

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients at least 18 years of age
    • * At least one documented, intradural, intracranial aneurysm, ruptured within last 30 days
    • * SAH WFNS grade 4 or less
    • * The patient and aneurysm are considered appropriate for either surgical or endovascular treatment by the treating team

    Exclusion Criteria:

    • * Patients with absolute contraindications administration of contrast material (any type)
    • * Patients with AVM-associated aneurysms
    • * Aneurysm located at basilar apex
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 August 2012
  • First Submitted that Met QC Criteria 16 August 2012
  • First Posted 20 August 2012

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 July 2023
  • Last Update Posted 6 July 2023
  • Last Verified July 2023