Intracranial AneurysmPUFSNCT00777088

Pipeline for Uncoilable or Failed Aneurysms

A study testing Pipeline Embolization Device (PED) in people with Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 10 sites in 3 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

To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms (IA). Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Intracranial Aneurysm
What is being tested?: Pipeline Embolization Device (PED)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 10 sitesin 3 countries
Study dates: Oct 2008to 22 Sep 2014
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 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 21 to 75 years, inclusive
Patient has a single target IA in the anterior or posterior circulation that:
Is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous
Has a neck >4 mm or no discernible neck AND a size (maximum fundus diameter) >10 mm
Has a parent vessel with diameter 2.5 - 5.0 mm distal/proximal to the target IA
Subject has provided written informed consent using the Institutional Review Board (IRB)-approved consent form
Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements

Who cannot join

More than one IA requires treatment in the next 6 months
Subarachnoid hemorrhage from target IA in the past 60 days
Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
Irreversible bleeding disorder
Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
Inability to tolerate, documented evidence of adverse reaction or contraindication to study medications

Show all 17Show fewer

Stent in place at the target IA
Contraindication to CT scan or MRI
Allergy to contrast used in angiography that cannot be medically controlled
Known severe allergy to platinum or cobalt/chromium alloys
Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)
Woman of child-bearing potential who cannot provide a negative pregnancy test
Evidence of active infection at the time of treatment
Other conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known carotid stenosis)
Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
Extracranial stenosis greater than 50% in the carotid artery for anterior circulation aneurysms
Intracranial stenosis greater than 50% in the treated vessel

Trial locations and contacts

10 sites in 3 countries.

Country

City, postcode or hospital

10 sites in 3 countries

United States8 sites

University of Buffalo
Buffalo, New York
Rush University
Chicago, Illinois
New York University
New York, New York
Barrow Neurological Institute
Phoenix, Arizona, 85013
Mayo Clinic
Rochester, Minnesota
Washington University St. Louis
St Louis, Missouri
Stony Brook University
Stony Brook, New York
Central Du Page Hospital
Winfield, Illinois

Other trials in United States

Hungary1 site

National Institute of Neurosurgery
Budapest

Other trials in Hungary

Turkey (Türkiye)1 site

Hacettepe University
Ankara

Other trials in Turkey (Türkiye)

About this study

To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms (IA).

Read the detailed description

Patients with large or giant aneurysms of the internal carotid artery treated with PED. Angiographic follow-up occurs at 3 and 5 years.

Conditions: Intracranial Aneurysm
Being tested: Pipeline Embolization Device (PED)
Keywords: neurovascular embolization, therapeutic embolization
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 (PED)Device
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach

Study groups in NCT00777088
Study group	Role	What they receive
Pipeline	Experimental	Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Receives: Device: Pipeline Embolization Device (PED)

What is being measured

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

Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.
The number of participants with occurrence of major ipsilateral stroke or neurologic death after PED placement at 180-days and the occurrence of ipsilateral stroke or neurologic death after Pipeline Embolization Devices (PED) placement at 5-years.
Measured: 180-days and 5-years
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.
The count of Intracranial Aneurysms (IA) evaluated as completely occluded (defined as Raymond Grade 1) without major parent artery stenosis at 180 days. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows:
Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac
Measured: 180 days

Secondary outcomes (7)

Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year
The count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) (defined as Raymond-Roy grade 1) 1 year follow-up visit. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows:
Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac
Measured: 1 Year
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up
The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 3 year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows:
Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac
Measured: 3 years
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years
The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 5-year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows:
Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac
Measured: 5 years
Stenosis of the Parent Artery in PED at 3 Years
Parent artery stenosis (narrowing of the artery from which the aneurysm arises) at 3-year follow-up
Measured: 3-years
Stenosis of the Parent Artery in PED at 5 Years
Parent artery stenosis at 5-year follow-up
Measured: 5-years
Number of Participants With Device-Related Adverse Events at 3 Years
Number of participants with incidence of device-related adverse events at 3 year follow-up
Measured: 3 years
Number of Participants With Device-related Adverse Events at 5 Years
Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement
Measured: 5 years

Timeline

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

Oct 200822 Sep 2014

First posted22 Oct 2008 (estimated)
Study startOct 2008
Primary completion22 Sep 2014
Study completion22 Sep 2014

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 (2)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: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00777088
Sponsor's protocol ID: COVPUFS0398
Acronym: PUFS
Status last verified: Oct 2018
First submitted: 20 Oct 2008
Last updated: 20 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Becske T, Potts MB, Shapiro M, Kallmes DF, Brinjikji W, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg. 2017 Jul;127(1):81-88. doi: 10.3171/2015.6.JNS15311. Epub 2016 Oct 14.
PubMed 27739944
Sahlein DH, Fouladvand M, Becske T, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Kallmes DF, Nelson PK. Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results. J Neurosurg. 2015 Oct;123(4):897-905. doi: 10.3171/2014.12.JNS141777. Epub 2015 Jul 10.
PubMed 26162031

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 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pipeline for Uncoilable or Failed Aneurysms
ClinicalTrials.gov ID: NCT00777088
Acronym / sponsor ID: PUFS / COVPUFS0398
Conditions: Intracranial Aneurysm
Keywords: neurovascular embolization, therapeutic embolization
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
Study start: Oct 2008 (actual)
Primary completion: 22 Sep 2014 (actual)
Study completion: 22 Sep 2014 (actual)
First posted: 22 Oct 2008 (estimated)
Results: Posted 11 Sep 2018

Clinical summary

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

To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms (IA).

Detailed description

Patients with large or giant aneurysms of the internal carotid artery treated with PED. Angiographic follow-up occurs at 3 and 5 years.

Study design

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

Arm	Type	Receives
Pipeline	Experimental	Device: Pipeline Embolization Device (PED)Placement of Pipeline Embolization Device in the parent artery at the aneurysm location

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 21 to 75 years, inclusive
Patient has a single target IA in the anterior or posterior circulation that:
Subject has provided written informed consent using the Institutional Review Board (IRB)-approved consent form
Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements

Key exclusion criteria (17 listed)

More than one IA requires treatment in the next 6 months
Subarachnoid hemorrhage from target IA in the past 60 days
Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
Irreversible bleeding disorder
Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction

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 (PED)1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach	Device	Pipeline

Primary outcome

Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.
Time frame: 180-days and 5-years
The number of participants with occurrence of major ipsilateral stroke or neurologic death after PED placement at 180-days and the occurrence of ipsilateral stroke or neurologic death after Pipeline Embolization Devices (PED) placement at 5-years.
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.
Time frame: 180 days
The count of Intracranial Aneurysms (IA) evaluated as completely occluded (defined as Raymond Grade 1) without major parent artery stenosis at 180 days. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac

7 secondary outcomes

Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year
Time frame: 1 Year
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up
Time frame: 3 years
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years
Time frame: 5 years
Stenosis of the Parent Artery in PED at 3 Years
Time frame: 3-years
Stenosis of the Parent Artery in PED at 5 Years
Time frame: 5-years
Number of Participants With Device-Related Adverse Events at 3 Years
Time frame: 3 years
Number of Participants With Device-related Adverse Events at 5 Years
Time frame: 5 years

Results and safety

Results posted to the registry on 11 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pipeline	108	107

Primary outcome: Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.

Time frame: 180-days and 5-years. Count of participants. Unit: Participants

Measure	Pipeline n = 107
180-Days	6
5-Years	10

Pipeline: p <.001, Bayesian

Population analysed: Patients treated with one or more Pipeline Embolization Devices.

Primary outcome: Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.

Time frame: 180 days. Count of units. Unit: Fully Occluded Intracranial Aneurysms

Measure	Pipeline n = 104
Value	78

Pipeline: p <0.001, Bayesian

Population analysed: A total of 104 participants and 106 intracranial aneurysms treated with the Pipeline Embolization Device were included in the primary effectiveness endpoint analysis.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Cumulative incidence rate of adverse events observed at 5 years.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pipeline	55 of 107 (51.4%)	74 of 107 (69.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27739944Becske T, Potts MB, Shapiro M, Kallmes DF, Brinjikji W, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg. 2017 Jul;127(1):81-88. doi: 10.3171/2015.6.JNS15311. Epub 2016 Oct 14.
Derived from this study: PubMed 26162031Sahlein DH, Fouladvand M, Becske T, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Kallmes DF, Nelson PK. Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results. J Neurosurg. 2015 Oct;123(4):897-905. doi: 10.3171/2014.12.JNS141777. Epub 2015 Jul 10.

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Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
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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.

Tibor Bescke, MD principal investigator

New York University

10 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pipeline Embolization Device (PED) in people with Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 10 sites in 3 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 7 inclusion and 17 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 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Hungary, Turkey (Türkiye). 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 11 Sep 2018). 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?

Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death. (time frame: 180-days and 5-years). 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 NCT00777088, which also lists 2 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 20 Nov 2018.