NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

NCT ID: NCT06604884

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2033-09-30

Brief Summary

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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

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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).

Conditions

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Intracranial Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Treatment of Intracranial Aneurysms

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Neurovascular Clinical Affairs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harsh Sancheti

Role: STUDY_DIRECTOR

Medtronic

Locations

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McLaren Healthcare

Flint, Michigan, United States

Site Status

Countries

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United States

Central Contacts

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Medtronic Neurovascular Clinical Affairs

Role: CONTACT

949-837-3700

Facility Contacts

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Marci Roberts

Role: primary

810-342-4071

Kiona Graham

Role: backup

810-342-4072

Other Identifiers

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MDT24028

Identifier Type: -

Identifier Source: org_study_id