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

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ClinicalTrials.gov Identifier: NCT02186561
Recruitment Status : Active, not recruiting
First Posted : July 10, 2014
Last Update Posted : November 19, 2018
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PREMIER PROSPECTIVE STUDY ON EMBOLIZATION OF INTRACRANIAL ANEURYSMS WITH PIPELINE™ EMBOLIZATION DEVICE
Study Start Date : July 2014
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : November 2019

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. Occurrence of major stroke or neurological death [ Time Frame: 1 year ]
  2. Complete aneurysm occlusion [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Occurrence of major stroke or neurological death [ Time Frame: 30 day ]

Other Outcome Measures:
  1. Device-related neurologic adverse event [ Time Frame: 1 year ]
  2. Aneurysm occlusion [ Time Frame: 3 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
  • Age 22-80 years.
  • Subject has a target intracranial aneurysm (IA) located in the anterior or posterior circulation.
  • Subject has a target IA with a wide aneurysm neck.

Exclusion Criteria:

  • Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks.
  • Major surgery in the last 30 days.
  • History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.
  • Any known contraindication to treatment with the Pipeline™ device.
  • Pregnant women.
  • Participating in another clinical trial.

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


  Show 23 Study Locations
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
Study Director: Manejeh Yaqub, MD Medtronic Neurovascular Clinical Affairs

Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02186561     History of Changes
Obsolete Identifiers: NCT02178007
Other Study ID Numbers: NV-PED-07
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

Keywords provided by Medtronic Neurovascular Clinical Affairs:
intracranial aneurysm
brain aneurysm

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases