Neurovascular Product Surveillance Registry (INSPIRE) Pipeline™ Flex Embolization Device With Shield Technology™ Post Approval Study (PAS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 246
- Locations
- 16
- Primary Endpoint
- Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure.
Study Overview
Brief Summary
The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Flex Embolization Device with Shield Technology™ ("Pipeline™ Shield Device") in a real-world post approval setting within the United States.
Detailed Description
The INSPIRE Pipeline™ Shield Post Approval Study is an observational, prospective, multi-center, single-arm registry to collect on-label use data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™ according to the intended use.
The primary objective of this study is to evaluate the on-label use of the Pipeline™ Shield Device in patients undergoing treatment for intracranial aneurysms per institutional routine clinical care in a real-world post approval study setting in the U.S.
This study is conducted under the Product Surveillance Registry (NCT01524276) and is a sub-study to the therapy specific Neurovascular Product Surveillance Registry (NCT02988128).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
- •Patient is intended to receive or be treated with an eligible Medtronic product.
- •Patient is consented within the enrollment window of the therapy received, as applicable.
- •Patient or patient's legally authorized representative (LAR) has provided written informed consent using the IRB and Medtronic approved Informed Consent Form and agrees to comply with the study requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR).
- •Patient has already been selected for endovascular treatment of the target aneurysm with the Pipeline™ Shield Device as the appropriate treatment per the Pipeline™ Shield Device Instructions For Use (IFU).
Exclusion Criteria
- •Patient who is, or is expected to be, inaccessible for follow-up.
- •Participation is excluded by local law.
- •Patient is currently enrolled or plans to enroll in a concurrent drug/device study that may confound the PSR results (i.e. no required intervention that could affect interpretation of all-around product safety and/or effectiveness).
- •Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
- •Patient is contraindicated for the device or procedure per the Pipeline™ Shield Device IFU.
- •The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
- •Patient is enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval was obtained from Medtronic.
Outcomes
Primary Outcomes
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
Incidence at 1-year post-procedure of complete occlusion of the target aneurysm, significant parent artery stenosis ≤ 50%, and no retreatment of the target aneurysm.
Secondary Outcomes
No secondary outcomes reported