Intracranial AneurysmPREMIERNCT02186561

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

A study testing Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device in people with Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 22 to 80 years
Conditions the study is for: Intracranial Aneurysm
What is being tested?: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 197 participants
Where: 23 sitesin 2 countries
Study dates: 24 Jul 2014to 13 Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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:

Show all 14Show fewer

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.

Trial locations and contacts

23 sites in 2 countries.

Country

City, postcode or hospital

23 sites in 2 countries

United States22 sites

The Emory Clinic
Atlanta, Georgia, 30322
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Tufts University Medical Center
Boston, Massachusetts, 02111
Kaleida Health/University of Buffalo
Buffalo, New York, 14203
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
Geisinger Medical Center
Danville, Pennsylvania, 17822
Radiology Imaging Associates
Englewood, Colorado, 80112
St. Luke's Health Baylor College of Medicine
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
Baptist Medical Center Jacksonville
Jacksonville, Florida, 32207
Baptist Physicians Lexington
Lexington, Kentucky, 40503
University of Kentucky
Lexington, Kentucky, 40536
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84132
Stony Brook University
Stony Brook, New York, 11794
Tampa General Hospital
Tampa, Florida, 33606
Florida Hospital
Winter Park, Florida, 32789
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655

Other trials in United States

Canada1 site

Toronto Western Hospital
Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: Prospective Study on Embolization of Intracranial Aneurysms With the Pipeline™ Device (PREMIER)

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.

Conditions: Intracranial Aneurysm
Being tested: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device
Keywords: Intracranial aneurysm, brain aneurysm
Medical subject headings: Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pipeline™ Embolization Device/ Pipeline™Flex Embolization DeviceDevice

Study groups in NCT02186561
Study group	Role	What they receive
Pipeline™ Embolization Device	Experimental	treatment with Pipeline™ Embolization Device Receives: Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 12 Months Post Procedure
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.
Measured: Up to 12 Months Post Procedure

Secondary outcomes (3)

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.
Measured: Up to 30 days, Post Procedure
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.
Measured: > 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.
Measured: Index Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jul 201413 Dec 2018

First posted10 Jul 2014 (estimated)
Study start24 Jul 2014
Primary completion18 Nov 2016
Study completion13 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 197 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02186561
Sponsor's protocol ID: NV-PED-07
Acronym: PREMIER
Status last verified: Dec 2019
First submitted: 8 Jul 2014
Last updated: 27 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated device: Yes
Individual data sharing: No: No, there is not a plan to make IPD available.

Publications

Rodriguez-Erazu F, Cortez GM, Lopes DK, Gutierrez-Aguirre SF, De Toledo OF, Aghaebrahim A, Sauvageau E, Kallmes DF, Fiehler J, Hanel RA. Braids and beyond: a comprehensive study on pipeline device braid stability from PREMIER data. J Neurointerv Surg. 2025 Nov 18;17(12):1362-1367. doi: 10.1136/jnis-2024-022350.
PubMed 39357888
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.
PubMed 35292570
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.
PubMed 31308197

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intracranial Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Study on Embolization of Intracranial Aneurysms With the Pipeline™ Device (PREMIER)
ClinicalTrials.gov ID: NCT02186561
Acronym / sponsor ID: PREMIER / NV-PED-07
Conditions: Intracranial Aneurysm
Keywords: Intracranial aneurysm, brain aneurysm
Study type: Interventional
Recruitment status: Completed
Enrolment: 197 participants (actual)
Lead sponsor: Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
Study start: 24 Jul 2014 (actual)
Primary completion: 18 Nov 2016 (actual)
Study completion: 13 Dec 2018 (actual)
First posted: 10 Jul 2014 (estimated)
Results: Posted 21 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pipeline™ Embolization Device	Experimental	Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Devicetreatment with Pipeline™ Embolization Device

Who may qualify

Ages: 22 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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:
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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device	Device	Pipeline™ Embolization Device

Primary outcome

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.

3 secondary outcomes

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
The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure
Time frame: > 30 days, Post Procedure
The Number of Participants With Successfully Deployed Investigational Device
Time frame: Index Procedure

Results and safety

Results posted to the registry on 21 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PREMIER	197	141

Primary outcome: 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. Number. Unit: percentage of participants

Measure	PREMIER n = 141
Value	2.17

Population analysed: Participants enrolled and implanted with the Investigational Device (ITT)

Primary outcome: 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. Number. Unit: Percentage of Participants

Measure	PREMIER n = 141
Value	76.71

Population analysed: Participants Treated with Investigational Device that Completed the 12 Month Visit Imaging

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from the point of consent through year 3. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CEC Adjudicated Adverse Events Through 1-Year	39 of 141 (27.7%)	107 of 141 (75.9%)	1 of 141
CEC Adjudicated Adverse Events Through 2-Year	49 of 141 (34.8%)	112 of 141 (79.4%)	1 of 141
CEC Adjudicated Adverse Events Through 3-Year	60 of 141 (42.6%)	112 of 141 (79.4%)	2 of 141

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39357888Rodriguez-Erazu F, Cortez GM, Lopes DK, Gutierrez-Aguirre SF, De Toledo OF, Aghaebrahim A, Sauvageau E, Kallmes DF, Fiehler J, Hanel RA. Braids and beyond: a comprehensive study on pipeline device braid stability from PREMIER data. J Neurointerv Surg. 2025 Nov 18;17(12):1362-1367. doi: 10.1136/jnis-2024-022350.
Derived from this study: PubMed 35292570Hanel 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.
Derived from this study: PubMed 31308197Hanel 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.
Individual participant dataSharing planned: No. No, there is not a plan to make IPD available.

Related trials for Intracranial Aneurysm

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ricardo Hanel, M.D. principal investigator

Baptist Medical Center

23 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device in people with Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Up to 12 Months Post Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02186561, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019.