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NCT06604884Recruiting

NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

Medtronic Neurovascular Clinical Affairs

Start Date

12/12/2025

Completion Date

9/1/2033

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).

Eligibility Criteria

Age Range: 22 years to No maximum

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.

Interventions

DEVICE

Treatment of Intracranial Aneurysms

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Conditions

Intracranial Aneurysm

Locations

Baptist Medical Center Jacksonville

Jacksonville, Florida 32207

United States

Wellstar Research Institute

Marietta, Georgia 30060

United States

Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine

Carmel, Indiana 46032-3318

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242

United States

McLaren Healthcare

Flint, Michigan 48532

United States

Prisma Health

Greenville, South Carolina 29605

United States

Semmes Murphey Clinic/Semmes Murphy Foundation

Memphis, Tennessee 38120

United States