NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment of Intracranial Aneurysms.
- Who it may be relevant to
- Registry conditions: Intracranial Aneurysm. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neurovascular Product Surveillance Registry (NV PSR INSPIRE) Pipeline™ Vantage Embolization Device With Shield Technology™ Post Approval Study (PAS)
Overview
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.
Detailed description
The INSPIRE Pipeline™ Vantage Post Approval Study is a, prospective, multi-center, single-arm clinical study to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™.
This study is a sub-study to the Neurovascular Product Surveillance Registry (NCT02988128).
Interventions
- Device Treatment of Intracranial Aneurysms
Embolization of aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™
Primary outcome measures
- Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure. [Time frame: 1 Year]
Eligibility criteria
Inclusion criteria
- 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.
- Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™.
- Patient is an adult per local law at time of consent.
Exclusion criteria
- Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU.
- Patient who may be unable to complete the study follow-up.
- The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
- Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
- Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- Baptist Medical Center Jacksonville — Jacksonville
- Wellstar Research Institute — Marietta
- Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine — Carmel
- University of Iowa Hospitals and Clinics — Iowa City
- McLaren Healthcare — Flint
- Prisma Health — Greenville
- Semmes Murphey Clinic/Semmes Murphy Foundation — Memphis
Identifiers
NCT: NCT06604884 · MDT24028