NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
ConditionIntracranial Aneurysm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorMedtronic Neurovascular Clinical Affairs
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients requiring treatment for intracranial aneurysms with the market approved Pipeline™ Vantage Embolization Device with Shield Technology™ device are eligible for the registry
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Treatment of Intracranial Aneurysms
DeviceEmbolization of aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure.
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.
Time frame
1 YearSponsors and contacts
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Source ClinicalTrials.gov