Clinical trial NCT02186561: Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device
Official title: Prospective Study on Embolization of Intracranial Aneurysms With the Pipeline™ Device (PREMIER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: Intracranial aneurysm
brain aneurysm
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 197
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.


Eligibility criteria: Inclusion Criteria:

1. Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
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:

1. Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks.
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.

Primary outcomes:
measure: The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure
timeFrame: Up to 12 Months Post Procedure
measure: The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure
timeFrame: Up to 12 Months Post Procedure
Secondary outcomes:
measure: The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications
timeFrame: Up to 30 days, Post Procedure
measure: The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure
timeFrame: > 30 days, Post Procedure
measure: The Number of Participants With Successfully Deployed Investigational Device
timeFrame: Index Procedure
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Radiology Imaging Associates
state: Colorado
city: Jacksonville
country: United States
facility: Baptist Medical Center Jacksonville
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Winter Park
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Lexington
country: United States
facility: Baptist Physicians Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts University Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Buffalo
country: United States
facility: Kaleida Health/University of Buffalo
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Houston
country: United States
facility: St. Luke's Health Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Baptist Medical Center
name: Ricardo Hanel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.