Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device (PREMIER)
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|ClinicalTrials.gov Identifier: NCT02186561|
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : May 21, 2019
Last Update Posted : December 27, 2019
|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 :||197 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Pipeline™ Embolization Device
treatment with Pipeline™ Embolization Device
Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Principal Investigator:||Ricardo Hanel, M.D.||Baptist Medical Center|