Status:
UNKNOWN
Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms
Lead Sponsor:
Gold Coast Hospital and Health Service
Collaborating Sponsors:
Prince of Wales Hospital, Sydney
Liverpool Hospital, Sydney
Conditions:
Intracranial Aneurysm
Cerebral Aneurysm
Eligibility:
All Genders
18-100 years
Brief Summary
This observational, retrospective, single-arm, multi-centre cohort study will use real-world data (RWD) to develop real-world evidence (RWE) of the safety and clinical effectiveness of the Pipeline™ F...
Detailed Description
Methodology summary: Single-arm, longitudinal, retrospective, multi-centre cohort study. A collaboration of Australian Interventional Neuroradiologists will create a data bank of existing clinical and...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years of age
- Medical records from patients that have received a Pipeline™ Flex Embolization Device with Shield Technology™ inclusive of all indications such as an elective procedure, unscheduled procedure or emergency procedure for an unruptured or ruptured intracranial aneurysm(s) at each study site
- Medical records from patients that have received other neurovascular therapies such as coils, intracranial stents etc. with a Pipeline™ Flex Embolization Device with Shield Technology™ used as an adjunctive device during the index procedure
Exclusion
- Medical records from patients that have not received a Pipeline™ Flex Embolization Device with Shield Technology™ to treat an intracranial aneurysm
Key Trial Info
Start Date :
May 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03815149
Start Date
May 30 2019
End Date
September 30 2020
Last Update
December 10 2019
Active Locations (4)
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1
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2000
2
Liverpool Hospital
Sydney, New South Wales, Australia, 2170
3
Gold Coast University Hospital
Gold Coast, Queensland, Australia, 4215
4
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia, 6009