ClinicalTrials.gg
RecruitingNCT06604884Updated Oct 23, 2026

NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

An observational study in Intracranial Aneurysm, sponsored by Medtronic Neurovascular Clinical Affairs. Recruiting at 10 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Medtronic Neurovascular Clinical Affairs (part of Medtronic) · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Updated Oct 23, 20261 site addedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
118
Ages
22 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Intracranial Aneurysm

Browse trials for

03

In context

Intracranial Aneurysm

418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.

This study's planned enrollment of 118 is below the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

Medtronic Neurovascular Clinical Affairs is the lead sponsor of 32 studies on the registry; 4 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient or legally authorized representative (LAR) has provided written 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

Exclusion Criteria:

  1. Patient with any 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
118 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • DeviceTreatment of Intracranial Aneurysms

    Embolization of aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™

06

What researchers measure

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 Year

07

Study locations

10 of 10 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — No individual participant data will be available

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Aug 2029, 44 months after the start.

Of 104 observational studies under Intracranial Aneurysm, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 145. This study's planned 44 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2024
First posted
Sep 20, 2024
StartActual
Dec 12, 2025
Primary completionEst.
Aug 2029
CompletionEst.
Sep 2033
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added
Show site
  • Buffalo Medical Center · Buffalo, United States
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    1 site added
    Show site
    • Buffalo Medical Center · Buffalo, United States
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06604884
Responsible party
Sponsor
First posted
Sep 20, 2024
Start date
Dec 12, 2025
Primary completion
Aug 2029 (estimated)
Completion
Sep 2033 (estimated)
Last update
Oct 23, 2026

Study contacts

Medtronic Neurovascular Clinical Affairs
Contact
rs.vantagepas@medtronic.com
949-837-3700
Harsh Sancheti
study director · Medtronic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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