Treatment of Intracranial Aneurysms: Embolization of aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™
Study summary
The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Vantage PAS") is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Vantage Embolization Device with Shield Technology™ ("Pipeline™ Vantage Device") in a post approval setting.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patient or legally authorized representative (LAR) has provided written informed consent using the Ethics Board and Medtronic approved Informed Consent Form and agrees to comply with the protocol requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR) as applicable per local law.
2. Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™.
3. Patient is an adult per local law at time of consent.
Exclusion Criteria:
1. Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU.
2. Patient who may be unable to complete the study follow-up.
3. The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
4. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
5. Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.
Primary outcome measure(s)
Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure. — 1 Year Incidence of complete occlusion of the target intracranial aneurysm (Raymond-Roy I) without significant parent artery stenosis (≤ 50%) nor re-treatment of the target intracranial aneurysm at 1-year post-procedure.
Trial sites (8)
Facility
City
Region
Status
Baptist Medical Center Jacksonville
Jacksonville
Florida
Recruiting
Wellstar Research Institute
Marietta
Georgia
Recruiting
Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine
Carmel
Indiana
Recruiting
University of Iowa Hospitals and Clinics
Iowa City
Iowa
Recruiting
McLaren Healthcare
Flint
Michigan
Recruiting
Washington University in Saint Louis
St Louis
Missouri
Recruiting
Prisma Health
Greenville
South Carolina
Recruiting
Semmes Murphey Clinic/Semmes Murphy Foundation
Memphis
Tennessee
Recruiting
More Medtronic Neurovascular Clinical Affairs trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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