Recruiting

Pipeline™ Vantage

Sponsor:

Medtronic Neurovascular Clinical Affairs

Code:

NCT06604884

Conditions

Intracranial Aneurysm

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Treatment of Intracranial Aneurysms

Study Details

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

Study ID

NCT06604884

Start date

Dec 12, 2025

Status verified date

Aug, 2026

Completion date

Sep, 2033

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

118 participants

Anticipated

Interventions and Outcome Measures

Interventions

Treatment of Intracranial Aneurysms

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

Primary outcome measure

  • Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure. [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Medtronic Neurovascular Clinical Affairs

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

Locations

Baptist Medical Center Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Principal Investigator:

Ricardo Hanel

Wellstar Research Institute

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Principal Investigator:

Ahmad Khaldi

Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine

Recruiting

Carmel, Indiana, United States, 46032-3318

Contacts

Principal Investigator:

Daniel Sahlein

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Principal Investigator:

Edgar Samaniego

McLaren Healthcare

Recruiting

Flint, Michigan, United States, 48532

Contacts

Principal Investigator:

Mahmoud Rayes

Washington University in Saint Louis

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Principal Investigator:

Arindam Chatterjee

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Mohammad Imran Chaudry

Semmes Murphey Clinic/Semmes Murphy Foundation

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Principal Investigator:

Violiza Inoa

More Information

Sponsor

Medtronic Neurovascular Clinical Affairs

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medtronic Neurovascular Clinical Affairs on 2026-08-12.