International Subarachnoid Aneurysm Trial II

NCT01668563 | Active Not Recruiting DMC

• 1 other identifier: CE 12.136
• Study Type: interventional
• Target: 1,724
• Locations: 3 countries
• Sites: 6

Brief Summary

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

Keywords

Aneurysm; Intracranial Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• poor clinical outcome(mRS>2)

  Number of patients experiencing a poor clinical outcome at one year post-treatment, defined as a modified Rankin Scale (mRS) score of \>2.

  12 months

Secondary Outcomes (6)

• Occurrence of an intracranial hemorrhage following treatment

  one year

• Failure of aneurysm occlusion using the intended treatment modality

  within 48 hours after attempted treatment

• Overall mortality and morbidity

  one year and five years

• Occurence of a "major" (saccular) aneurysm recurrence

  12 months (+/- 2 months)

• Peri-treatment hospitalization lasting more than 20 days and/or discharge to a location other than home

  within a month or at discharge if earlier

Study Arms (2)

Endovascular management

ACTIVE COMPARATOR

Endovascular treatment will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling, stents or flow-diverters, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.

Procedure: Endovascular management

Surgical management

ACTIVE COMPARATOR

Surgical clipping will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, construction of a surgical bypass, or other flow-redirecting treatments that do not directly clip the aneurysm will not be excluded; these non-ISAT aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.

Procedure: surgical management

Interventions

surgical management PROCEDURE

Surgical clipping will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, construction of a surgical bypass, or other flow-redirecting treatments that do not directly clip the aneurysm will not be excluded; these non-ISAT aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.

Surgical management

Endovascular management PROCEDURE

Endovascular treatment will also be performed as soon as possible following randomization,according to standards of practice, and under general anesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling, stents or flow-diverters, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.

Endovascular management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with absolute contraindications administration of contrast material (any type)
• Patients with AVM-associated aneurysms
• Aneurysm located at basilar apex

Sponsors & Collaborators

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

Study Sites (6)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

Montreal, Quebec, H2X 0C1, Canada

Location

Vall d'Hebron Hospital

Barcelona, Spain

Location

University of Valladolid

Valladolid, Spain

Location

Related Publications (5)

• Molyneux A, Kerr R, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. Lancet. 2002 Oct 26;360(9342):1267-74. doi: 10.1016/s0140-6736(02)11314-6.

  PMID: 12414200 BACKGROUND

• Gnanalingham KK, Apostolopoulos V, Barazi S, O'Neill K. The impact of the international subarachnoid aneurysm trial (ISAT) on the management of aneurysmal subarachnoid haemorrhage in a neurosurgical unit in the UK. Clin Neurol Neurosurg. 2006 Feb;108(2):117-23. doi: 10.1016/j.clineuro.2005.11.001. Epub 2005 Dec 20.

  PMID: 16364540 BACKGROUND

• McDougall CG, Spetzler RF, Zabramski JM, Partovi S, Hills NK, Nakaji P, Albuquerque FC. The Barrow Ruptured Aneurysm Trial. J Neurosurg. 2012 Jan;116(1):135-44. doi: 10.3171/2011.8.JNS101767. Epub 2011 Nov 4.

  PMID: 22054213 BACKGROUND

• Raymond J, Kotowski M, Darsaut TE, Molyneux AJ, Kerr RS. Ruptured aneurysms and the International Subarachnoid Aneurysm Trial (ISAT): What is known and what remains to be questioned. Neurochirurgie. 2012 Apr-Jun;58(2-3):103-14. doi: 10.1016/j.neuchi.2012.02.020. Epub 2012 Apr 4. English, French.

  PMID: 22481029 BACKGROUND

• Darsaut TE, Jack AS, Kerr RS, Raymond J. International Subarachnoid Aneurysm Trial - ISAT part II: study protocol for a randomized controlled trial. Trials. 2013 May 29;14:156. doi: 10.1186/1745-6215-14-156.

  PMID: 23714335 DERIVED

MeSH Terms

Conditions

Aneurysm; Intracranial Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tim Darsaut, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Max Findlay, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 20, 2012
• Study Start: November 12, 2012
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

US (1); ES (2); CA (3)