The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).

Part of paid clinical trials in Englewood, Colorado.

Sponsor
Medtronic Neurovascular Clinical Affairs
Study ID
NCT02998229
Status
Recruiting
Apply to this trial

Conditions

  • Intracranial Aneurysm

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Artisse™ Intrasaccular Device — DEVICE
    Intrasaccular Device

Study Details

The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.

Key Dates

Start date
Apr 16, 2024
Status verified
Feb 2026
Primary completion
Aug 31, 2027
Completion
Feb 29, 2032

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Artisse™ Intrasaccular Device
    Study subjects with an unruptured or ruptured wide-neck bifurcating intracranial aneurysm will be treated by endovascular implantation of the Artisse™ Intrasaccular Device.

Primary Outcome Measure

Effectiveness: Incidence of complete aneurysm occlusion [ Time Frame: 1 year post procedure ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Swedish Medical CenterEnglewoodColorado80113-2764
Ashley Thompson
[email protected]
(303) 907-5634
Ian Kaminsky, MD (PRINCIPAL_INVESTIGATOR)
Yale New Haven HospitalNew HavenConnecticut06519
Lindsey Fraczkiewicz
[email protected]
Charles Matouk, MD (PRINCIPAL_INVESTIGATOR)
Baptist Medical Center JacksonvilleJacksonvilleFlorida32207
Smitha Gubbi, MD
904-202-7069
Eric Sauvageau, MD (PRINCIPAL_INVESTIGATOR)
Tampa General HospitalTampaFlorida33606
Muni Sai Bachalakuri
[email protected]
813-844-8498
Maxim Mokin, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60673
Tareq Kass-Hout, MD (PRINCIPAL_INVESTIGATOR)
Advocate Lutheran General HospitalPark RidgeIllinois60068
Victor Arroyo
[email protected]
847-723-7950
Demitrius Lopes, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Heena Olalde
[email protected]
319-356-8326
Edgar Samaniego, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Shayna Hollander
[email protected]
(617) 643-5547
Aman B. Patel, MD (PRINCIPAL_INVESTIGATOR)
Cooper University HealthCamdenNew Jersey08103
Thuy Van Cao
[email protected]
(856) 342-2362
Daniel Tonetti, MD (PRINCIPAL_INVESTIGATOR)
Albany Medical CenterAlbanyNew York12208
Alexandra Paul, MD
Buffalo General Medical CenterBuffaloNew York14203
Adnan Siddiqui, MD
The Mount Sinai HospitalNew YorkNew York10029
Johanna Fifi, MD
Stony Brook University HospitalStony BrookNew York11794
Marlene Baumeister
[email protected]
631-444-1610
David Fiorella, MD (PRINCIPAL_INVESTIGATOR)
Novant Health Brain and Spine SurgeryCharlotteNorth Carolina28211
Ziad Hage, MD
Cleveland Clinic FoundationClevelandOhio44195
Heidi Poppendeck
[email protected]
Ashutosh Mahapatra, MD (PRINCIPAL_INVESTIGATOR)
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Christopher Boivin
[email protected]
Jan-Karl Burkhardt, MD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Pascal Jabbour, MD (PRINCIPAL_INVESTIGATOR)
UPMC PresbyterianPittsburghPennsylvania15213-2536
Lauren Puccio
[email protected]
Bradley Gross, MD (PRINCIPAL_INVESTIGATOR)
Prisma HealthGreenvilleSouth Carolina29605
Mohammad Chaudry, MD
Semmes Murphy ClinicMemphisTennessee38120
Wendell Barnett
[email protected]
901-260-6124
Violiza Inoa, MD (PRINCIPAL_INVESTIGATOR)
University of Utah HospitalSalt Lake CityUtah84132
Ramesh Grandhi, MD
West Virginia UniversityMorgantownWest Virginia26506-9260
Jennifer Domico
[email protected]
(304) 598-6930
Ansaar Rai, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Englewood, CO

By research site
Swedish Medical Center· Englewood, COYale New Haven Hospital· New Haven, CTBaptist Medical Center Jacksonville· Jacksonville, FLTampa General Hospital· Tampa, FLUniversity of Chicago· Chicago, ILAdvocate Lutheran General Hospital· Park Ridge, IL

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