Intracranial AneurysmNCT06604884
NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
An observational study of Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 10 sites in United States.
Trial 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™… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Treatment of Intracranial Aneurysms
- Type of treatment
- Medical device
- How many people
- 118 participants
- Where
- 10 sitesUnited States
- Study dates
- 12 Dec 2025to Sep 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Buffalo Medical Center
Buffalo, New York, 14203
Ellen Carl, 716-218-1000 ext. 7260, ecarl@ubns.com
Adnan Siddiqui
- Recruiting
Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine
Carmel, Indiana, 46032-3318
Luke Watkins, (317) 396-1300, lwatkins@goodmancampbell.com
Daniel Sahlein
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Maria Budz, 847-570-1037, maria.budz@endeavorhealth.org
William Ares
- Recruiting
McLaren Healthcare
Flint, Michigan, 48532
Marci Roberts, 810-342-4071, Marci.Roberts@mclaren.org
Kiona Graham, 810-342-4072, Kiona.Graham@mclaren.org
- Recruiting
Prisma Health
Greenville, South Carolina, 29605
Shawn Manos, 864-455-1889, shawn.manos@prismahealth.org
Mohammad Imran Chaudry
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Heena Olalde, 319-356-8326, heena-olalde@uiowa.edu
Edgar Samaniego, edgar-samaniego@uiowa.edu
- Recruiting
Baptist Medical Center Jacksonville
Jacksonville, Florida, 32207
Teresa Nicol, 904-202-7998, Teresa.nicol@bmcjax.com
Ricardo Hanel
- Recruiting
Wellstar Research Institute
Marietta, Georgia, 30060
Shelita Kithcart, 470-793-5121, Shelita.Kithcart@wellstar.org
Ahmad Khaldi
- Recruiting
Semmes Murphey Clinic/Semmes Murphy Foundation
Memphis, Tennessee, 38120
Courtney Berryman, 901-260-6111, cberryman@semmes-murphey.com
Violiza Inoa
- Recruiting
Washington University in Saint Louis
St Louis, Missouri, 63130
Rachel Reed, 314-747-3027, Rachel.Reed@wustl.edu
Arindam Chatterjee
About this study
Official title: Neurovascular Product Surveillance Registry (NV PSR INSPIRE) Pipeline™ Vantage Embolization Device With Shield Technology™ Post Approval Study (PAS)
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).
- Conditions
- Intracranial Aneurysm
- Being tested
- Treatment of Intracranial Aneurysms
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of Intracranial AneurysmsDevice
Embolization of aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start12 Dec 2025
- Primary completionAug 2029 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harsh Sancheti, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604884
- Sponsor's protocol ID
- MDT24028
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be available
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurovascular Product Surveillance Registry (NV PSR INSPIRE) Pipeline™ Vantage Embolization Device With Shield Technology™ Post Approval Study (PAS)
- ClinicalTrials.gov ID
- NCT06604884
- Acronym / sponsor ID
- MDT24028
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of Intracranial AneurysmsEmbolization of aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™ | Device | – |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. No individual participant data will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harsh Sancheti study director
Medtronic
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medtronic Neurovascular Clinical Affairs (949-837-3700, rs.vantagepas@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.