Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device
NCT ID: NCT02186561
Last Updated: 2019-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
197 participants
INTERVENTIONAL
2014-07-24
2018-12-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pipeline™ Embolization Device
treatment with Pipeline™ Embolization Device
Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device
Interventions
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Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device
Eligibility Criteria
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Inclusion Criteria
2. Age 22-80 years.
3. Subject has a target intracranial aneurysm (IA) located in the:
1. Internal carotid artery (up to the carotid terminus) OR
2. Vertebral artery segment up to and including the posterior inferior cerebellar artery
4. Subject has a target IA that is ≤ 12 mm.
5. Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA.
6. Subject has a target IA with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.5.
7. Subject has a pre-procedure PRU value between 60-200.
Exclusion Criteria
2. Subarachnoid hemorrhage in the past 30 days.
3. Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy.
4. Major surgery in the last 30 days.
5. History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.
6. Any known contraindication to treatment with the Pipeline™ device, including:
1. Stent is in place in the parent artery at the target IA location
2. Contraindication to dual antiplatelet therapy
3. Relative contraindication to angiography (e.g., serum creatinine \>2.5 mg/dL, allergy to contrast that cannot be medically controlled).
4. Known severe allergy to platinum or cobalt/chromium alloys.
5. Evidence of active infection at the time of treatment (e.g., fever with temperature \>38°C and/or WBC \>1.5 109/L).
7. The Investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment.
8. Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.
9. Participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation.
22 Years
80 Years
ALL
No
Sponsors
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Medtronic Neurovascular Clinical Affairs
INDUSTRY
Responsible Party
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Principal Investigators
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Ricardo Hanel, M.D.
Role: PRINCIPAL_INVESTIGATOR
Baptist Medical Center
Locations
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Radiology Imaging Associates
Englewood, Colorado, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Florida Hospital
Winter Park, Florida, United States
The Emory Clinic
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Baptist Physicians Lexington
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Tufts University Medical Center
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Kaleida Health/University of Buffalo
Buffalo, New York, United States
Stony Brook University
Stony Brook, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
St. Luke's Health Baylor College of Medicine
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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References
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Rodriguez-Erazu F, Cortez GM, Lopes DK, Gutierrez-Aguirre SF, De Toledo OF, Aghaebrahim A, Sauvageau E, Kallmes DF, Fiehler J, Hanel RA. Braids and beyond: a comprehensive study on pipeline device braid stability from PREMIER data. J Neurointerv Surg. 2025 Jan 27:jnis-2024-022350. doi: 10.1136/jnis-2024-022350. Online ahead of print.
Hanel RA, Cortez GM, Lopes DK, Nelson PK, Siddiqui AH, Jabbour P, Mendes Pereira V, Istvan IS, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer CM, Hellinger FR, Given C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS, Kallmes DF. Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification. J Neurointerv Surg. 2023 Mar;15(3):248-254. doi: 10.1136/neurintsurg-2021-018501. Epub 2022 Mar 15.
Hanel RA, Kallmes DF, Lopes DK, Nelson PK, Siddiqui A, Jabbour P, Pereira VM, Szikora Istvan I, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer C, Hellinger FR, Given Ii C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS. Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results. J Neurointerv Surg. 2020 Jan;12(1):62-66. doi: 10.1136/neurintsurg-2019-015091. Epub 2019 Jul 15.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NV-PED-07
Identifier Type: -
Identifier Source: org_study_id
NCT02178007
Identifier Type: -
Identifier Source: nct_alias