NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study | NCT06604884

Studies
NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

NCT06604884

Sponsor

Medtronic Neurovascular Clinical Affairs

Status

Recruiting

Last Update Posted

Jun 23, 2026Actual

Enrollment

118Estimated

Phase

Not provided

Conditions

Intracranial Aneurysm

Interventions

Treatment of Intracranial Aneurysms

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2025Actual

Primary Completion Date

Aug 2029Estimated

Completion Date

Sep 2033Estimated

First Submitted Date

Sep 17, 2024

First Submission Date that Met QC Criteria

Sep 17, 2024

First Posted Date

Sep 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2026

Last Update Posted Date

Jun 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

118Estimated

Name	Type	Description	Arm Group Labels	Other Names
Treatment of Intracranial Aneurysms	Device	Embolization of aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 Year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients requiring treatment for intracranial aneurysms with the market approved Pipeline™ Vantage Embolization Device with Shield Technology™ device are eligible for the registry

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Medtronic Neurovascular Clinical Affairs	Contact	949-837-3700		rs.vantagepas@medtronic.com

Overall Officials

Name	Affiliation	Role
Harsh Sancheti	Medtronic	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baptist Medical Center Jacksonville	Recruiting	Jacksonville	Florida	32207	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No individual participant data will be available

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002532	Intracranial Aneurysm

Ancestor Terms

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided