The rationale and design of the Giant Intracranial Aneurysm Registry

TY - JOUR

T1 - The rationale and design of the Giant Intracranial Aneurysm Registry

T2 - a retrospective and prospective study

AU - Dengler, Julius

AU - Heuschmann, Peter U

AU - Endres, Matthias

AU - Meyer, Bernhard

AU - Rohde, Veit

AU - Rufenacht, Daniel A

AU - Vajkoczy, Peter

AU - Giant Intracranial Aneurysm Registry Study Group

AU - Eicker, Sven-Oliver

N1 - © 2011 The Authors. International Journal of Stroke © 2011 World Stroke Organization.

PY - 2011/6

Y1 - 2011/6

N2 - AIMS AND HYPOTHESIS: Giant intracranial aneurysms have a poor prognosis mainly due to their high risk of rupture. Because their incidence is low, clinical trial evidence for adequate treatment is lacking. The Giant Intracranial Aneurysm Registry is designed to document current treatment strategies in giant aneurysm care and to monitor the course of the disease over five-years. It aims to evaluate the hypothesis that all three possible branches of therapy (conservative/endovascular/surgical) lead to equal rupture rates.DESIGN: The Giant Intracranial Aneurysm Registry is an interdisciplinary multicenter observational study. Each center recruits patients diagnosed with a giant intracranial aneurysm both prospectively and retrospectively. Primary outcome will be the aneurysm rupture rate at five-years of follow-up.STUDY OUTCOME: Patient enrollment has begun at 20 neurovascular centers throughout Germany, with 19 further centers applying for local ethics approval to take part in the study. The first nine months are designed as a pilot phase followed by the integration of study centers throughout the EU and the initiation of separate sub-studies.DISCUSSION: Giant intracranial aneurysms have often been ignored or marginalized due to their low incidence. The Giant Intracranial Aneurysm Registry aims to lead to a better understanding of these complex lesions and to serve as a basis for the development of future clinical studies.

AB - AIMS AND HYPOTHESIS: Giant intracranial aneurysms have a poor prognosis mainly due to their high risk of rupture. Because their incidence is low, clinical trial evidence for adequate treatment is lacking. The Giant Intracranial Aneurysm Registry is designed to document current treatment strategies in giant aneurysm care and to monitor the course of the disease over five-years. It aims to evaluate the hypothesis that all three possible branches of therapy (conservative/endovascular/surgical) lead to equal rupture rates.DESIGN: The Giant Intracranial Aneurysm Registry is an interdisciplinary multicenter observational study. Each center recruits patients diagnosed with a giant intracranial aneurysm both prospectively and retrospectively. Primary outcome will be the aneurysm rupture rate at five-years of follow-up.STUDY OUTCOME: Patient enrollment has begun at 20 neurovascular centers throughout Germany, with 19 further centers applying for local ethics approval to take part in the study. The first nine months are designed as a pilot phase followed by the integration of study centers throughout the EU and the initiation of separate sub-studies.DISCUSSION: Giant intracranial aneurysms have often been ignored or marginalized due to their low incidence. The Giant Intracranial Aneurysm Registry aims to lead to a better understanding of these complex lesions and to serve as a basis for the development of future clinical studies.

KW - Adolescent

KW - Adult

KW - Aged

KW - Aneurysm, Ruptured

KW - Female

KW - Follow-Up Studies

KW - Germany

KW - Humans

KW - Intracranial Aneurysm

KW - Male

KW - Middle Aged

KW - Patient Selection

KW - Prognosis

KW - Prospective Studies

KW - Registries

KW - Retrospective Studies

KW - Sample Size

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1111/j.1747-4949.2011.00588.x

DO - 10.1111/j.1747-4949.2011.00588.x

M3 - SCORING: Journal article

C2 - 21557815

VL - 6

SP - 266

EP - 270

JO - INT J STROKE

JF - INT J STROKE

SN - 1747-4930

IS - 3

ER -