NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Medtronic Neurovascular Clinical Affairs
Study ID
NCT06604884
Status
Recruiting
Apply to this trial

Conditions

  • Intracranial Aneurysm

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Treatment of Intracranial Aneurysms — DEVICE
    Embolization of aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™

Study Details

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.

Key Dates

Start date
Dec 12, 2025
Status verified
May 2026
Primary completion
Aug 31, 2029
Completion
Sep 30, 2033

Study Design

Enrollment
118 participants (estimated)

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

Locations (6)

FacilityCityStateZIPSite coordinators
Baptist Medical Center JacksonvilleJacksonvilleFlorida32207
Teresa Nicol
[email protected]
904-202-7998
Ricardo Hanel (PRINCIPAL_INVESTIGATOR)
Wellstar Research InstituteMariettaGeorgia30060
Kiarra Thomas
[email protected]
470-793-5121
Shelita Kithcart
[email protected]
470-793-5121
Ahmad Khaldi (PRINCIPAL_INVESTIGATOR)
Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and SpineCarmelIndiana46032-3318
Luke Watkins
[email protected]
317-396-1300
Daniel Sahlein (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Heena Olalde
[email protected]
319-356-8326
Edgar Samaniego
[email protected]
Edgar Samaniego (PRINCIPAL_INVESTIGATOR)
McLaren HealthcareFlintMichigan48532
Marci Roberts
[email protected]
810-342-4071
Kiona Graham
[email protected]
810-342-4072
Mahmoud Rayes (PRINCIPAL_INVESTIGATOR)
Semmes Murphey Clinic/Semmes Murphy FoundationMemphisTennessee38120
Courtney Berryman
[email protected]
901-260-6111
Violiza Inoa (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By research site
Baptist Medical Center Jacksonville· Jacksonville, FLWellstar Research Institute· Marietta, GAAscension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine· Carmel, INUniversity of Iowa Hospitals and Clinics· Iowa City, IAMcLaren Healthcare· Flint, MISemmes Murphey Clinic/Semmes Murphy Foundation· Memphis, TN

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