NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

NCT06604884 | Recruiting FDA Device

• 1 other identifier: MDT24028
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 4

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.

Conditions

Intracranial Aneurysm

Outcome Measures

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.

  1 Year

Interventions

Treatment of Intracranial Aneurysms DEVICE

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

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead

Study Sites (4)

Wellstar Research Institute

Marietta, Georgia, 30060, United States

RECRUITING

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

McLaren Healthcare

Flint, Michigan, 48532, United States

RECRUITING

Semmes Murphey Clinic/Semmes Murphy Foundation

Memphis, Tennessee, 38120, United States

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Harsh Sancheti

  Medtronic

  STUDY DIRECTOR

Central Study Contacts

Medtronic Neurovascular Clinical Affairs

CONTACT

949-837-3700; rs.vantagepas@medtronic.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 20, 2024
• Study Start: December 12, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): September 1, 2033
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)