Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device (PREMIER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02186561
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : May 21, 2019
Last Update Posted : December 27, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study on Embolization of Intracranial Aneurysms With the Pipeline™ Device (PREMIER)
Actual Study Start Date : July 24, 2014
Actual Primary Completion Date : November 18, 2016
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pipeline™ Embolization Device
treatment with Pipeline™ Embolization Device
Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device



Primary Outcome Measures :
  1. 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 [ Time Frame: Up to 12 Months Post Procedure ]
    The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.

  2. 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 [ Time Frame: Up to 12 Months Post Procedure ]

    The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac.

    Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.



Secondary Outcome Measures :
  1. 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 [ Time Frame: Up to 30 days, Post Procedure ]
    Major Stroke is defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Neurological death is any subject death due to neurologic reasons.

  2. The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure [ Time Frame: > 30 days, Post Procedure ]
    For the purpose of this protocol, delayed intracerebral hemorrhage was defined as hemorrhage within the fixed vault of the cranium (skull) occurring greater than 30 days post-procedure.

  3. The Number of Participants With Successfully Deployed Investigational Device [ Time Frame: Index Procedure ]
    The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186561


Locations
Show Show 23 study locations
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
Layout table for investigator information
Principal Investigator: Ricardo Hanel, M.D. Baptist Medical Center
  Study Documents (Full-Text)

Documents provided by Medtronic Neurovascular Clinical Affairs:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02186561    
Obsolete Identifiers: NCT02178007
Other Study ID Numbers: NV-PED-07
First Posted: July 10, 2014    Key Record Dates
Results First Posted: May 21, 2019
Last Update Posted: December 27, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No, there is not a plan to make IPD available.

Layout table for additional information
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Medtronic Neurovascular Clinical Affairs:
Intracranial aneurysm
brain aneurysm
Additional relevant MeSH terms:
Layout table for MeSH terms
Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases