Intracranial Aneurysm
Conditions
Brief 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.
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
Embolization of aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™
Sponsors
Medtronic Neurovascular Clinical Affairs
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTMedtronic Neurovascular Clinical Affairs
STUDY_DIRECTORHarsh Sancheti
Medtronic
Outcome results
None listed