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

Primary Purpose

Intracranial Aneurysm

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device
Sponsored by
Medtronic Neurovascular Clinical Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring Intracranial aneurysm, brain aneurysm

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Radiology Imaging Associates
  • Baptist Medical Center Jacksonville
  • Tampa General Hospital
  • Florida Hospital
  • The Emory Clinic
  • Rush University Medical Center
  • Baptist Physicians Lexington
  • University of Kentucky
  • The Johns Hopkins Hospital
  • Tufts University Medical Center
  • University of Massachusetts Memorial Medical Center
  • Mayo Clinic Rochester
  • Kaleida Health/University of Buffalo
  • Stony Brook University
  • Cleveland Clinic
  • Oregon Health and Science University
  • Geisinger Medical Center
  • Thomas Jefferson University Hospital
  • St. Luke's Health Baylor College of Medicine
  • The Methodist Hospital
  • University of Utah
  • University of Wisconsin Hospital and Clinics
  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pipeline™ Embolization Device

Arm Description

treatment with Pipeline™ Embolization Device

Outcomes

Primary Outcome Measures

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
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
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

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
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
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
The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.

Full Information

First Posted
July 8, 2014
Last Updated
December 17, 2019
Sponsor
Medtronic Neurovascular Clinical Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT02186561
Brief Title
Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device
Acronym
PREMIER
Official Title
Prospective Study on Embolization of Intracranial Aneurysms With the Pipeline™ Device (PREMIER)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 24, 2014 (Actual)
Primary Completion Date
November 18, 2016 (Actual)
Study Completion Date
December 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Neurovascular Clinical Affairs

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
Keywords
Intracranial aneurysm, brain aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pipeline™ Embolization Device
Arm Type
Experimental
Arm Description
treatment with Pipeline™ Embolization Device
Intervention Type
Device
Intervention Name(s)
Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 12 Months Post Procedure
Title
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
Description
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.
Time Frame
Up to 12 Months Post Procedure
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 30 days, Post Procedure
Title
The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure
Description
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.
Time Frame
> 30 days, Post Procedure
Title
The Number of Participants With Successfully Deployed Investigational Device
Description
The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.
Time Frame
Index Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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: Internal carotid artery (up to the carotid terminus) OR Vertebral artery segment up to and including the posterior inferior cerebellar artery Subject has a target IA that is ≤ 12 mm. Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA. Subject has a target IA with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.5. Subject has a pre-procedure PRU value between 60-200. Exclusion Criteria: Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks. Subarachnoid hemorrhage in the past 30 days. 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. 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, including: Stent is in place in the parent artery at the target IA location Contraindication to dual antiplatelet therapy Relative contraindication to angiography (e.g., serum creatinine >2.5 mg/dL, allergy to contrast that cannot be medically controlled). Known severe allergy to platinum or cobalt/chromium alloys. Evidence of active infection at the time of treatment (e.g., fever with temperature >38°C and/or WBC >1.5 109/L). 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. Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation. Participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Hanel, M.D.
Organizational Affiliation
Baptist Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiology Imaging Associates
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Baptist Medical Center Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Florida Hospital
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Baptist Physicians Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Tufts University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Kaleida Health/University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
St. Luke's Health Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No, there is not a plan to make IPD available.
Citations:
PubMed Identifier
35292570
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.
Results Reference
derived
PubMed Identifier
31308197
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.
Results Reference
derived

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Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device

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