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Intracranial AneurysmADVANCENCT03873714

Pipeline™ Vantage Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms (ADVANCE)

A study testing Pipeline™ Vantage Embolization Device with Shield Technology™ in people with Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the safety and effectiveness of the Pipeline™ Vantage Embolization Device with Shield Technology™ in the treatment of intracranial aneurysms within the intended indication for use. 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™ Vantage Embolization Device with Shield Technology™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesUnited States
Study dates
2 Apr 2020to 18 Sep 2023
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 a target intracranial aneurysm located in the internal carotid artery (up to the terminus).
  • Subject has a target intracranial aneurysm with an aneurysm neck ≥4mm or a dome-to-neck ratio of < 2.
  • Subject has a target intracranial aneurysm that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target intracranial aneurysm.
  • Subject (or subject's legally authorized representative) has provided written informed consent using the IRB and Medtronic approved Informed Consent Form and agrees to comply with protocol requirements. HIPAA/data protection authorization has been provided and signed by the subject (or subject's legally authorized representative).
  • Age 22-80 years at the time of consent.
  • Life expectancy ≥3 years
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  • Subject has a mRS ≤ 2 at baseline to be determined by a certified independent assessor at the site.
  • Subject has already been selected for endovascular treatment of the target aneurysm.
  • Subject's last recorded P2Y12 reaction units (PRU) value is between ≥60 and ≤200 prior to study procedure.
  • Subject has multiple increased risk factors for intracranial aneurysm rupture, including but not limited to, aneurysm morphology, smoking, hypertension, diabetes, age, prior and/or family history of rupture, and/or history of subarachnoid hemorrhage that may result in a benefit risk profile of endovascular treatment to outweigh the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.

Who cannot join

  • Subject has internal carotid artery bifurcation aneurysm.
  • Aneurysms that arise from the Posterior Communicating Artery (PComm).
  • The internal carotid artery aneurysms of the C7 segment will be excluded under the following conditions:
  • Observed fetal posterior communicating artery (PComm) of fetal origin (A PComm of fetal origin is defined as a small, hypoplastic, or absent P1 segment of the posterior cerebral artery (PCA) with the PComm artery supplying a majority of blood flow to the P2 and higher order segments of the PCA)
  • PComm overlapping with the aneurysm neck
  • PComm branch arising from the dome of the aneurysm
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  • Subject has aneurysm arising from internal carotid artery but is primarily fed by posterior circulation (i.e., retrograde flow from the basilar artery) as confirmed by DSA
  • Subject requires treatment of another aneurysm (with another treatment modality) within the affected territory of the target aneurysm during the study period.
  • Subject has received an intracranial implant (e.g. coils) in the area of the target intracranial aneurysm within the past 6 months prior to the study procedure.
  • Subject has had a SAH and/or target aneurysm rupture in the past 30 days prior to the study procedure.
  • Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
  • Aneurysm vessel characteristics (e.g. parent vessel stenosis, irregular morphology) that would preclude the device from fully confirming to the parent vessel to reduce any risk of embolic complications, retreatment, or device movement.
  • Subject has active vasospasm, malignant brain tumor or vascular malformation (e.g. arteriovascular malformation).
  • History of major bleeding disorder (based on coagulation profile and platelet count) and/or subject presents with signs of active bleeding.
  • Subject requires adjunctive device use (e.g. coils) during the index procedure.
  • Subject has extradural target aneurysm <12mm which is not symptomatic or not exhibiting aneurysm growth (exception: unless it is a fusiform aneurysm <12 mm i.e., asymptomatic extradural fusiform aneurysms <12 mm can be included).
  • Any known contraindication to treatment with the Pipeline™ Vantage Embolization Device with Shield Technology™, or use of antiplatelet therapy including:
  • Active bacterial infection
  • Contraindication to DAPT agents
  • Pre-existing stent is in place in the parent artery at the target intracranial aneurysm location
  • Platelet count < 100 x 10^3 cells/mm^3 or known platelet dysfunction.
  • The Investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, conditions that may increase the chance of stroke) may be compromised by the subject's enrollment.
  • Subject is pregnant or wishes to become pregnant during the first year of study participation.
  • Subject is participating in another clinical trial at any time during the duration of the study that could confound the treatment or outcomes of this investigation.
  • Subject with known allergy to platinum or cobalt chromium alloy (including the major elements platinum, cobalt, chromium, nickel or molybdenum).
  • History of previous acute ischemic stroke
  • Subject is unable to undergo DSA or CTA imaging at follow-up

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207

  • Jackson Memorial Hospital

    Miami, Florida, 33136

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: A Study of the Pipeline™ Vantage Embolization Device With Shield Technology™ for Endovascular Treatment of Wide-Necked Intracranial Aneurysms

The purpose of this study is to assess the safety and effectiveness of the Pipeline™ Vantage Embolization Device with Shield Technology™ in the treatment of intracranial aneurysms within the intended indication for use.

Read the detailed description

The safety of the Pipeline™ Vantage will be assessed through incidence of major stroke in the territory supplied by the treated artery or neurological death at 1-year post-procedure. The effectiveness of the Pipeline™ Vantage will be assessed through incidence of complete aneurysm occlusion (Raymond Roy Scale Class 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm at 1-year post-procedure. Additional safety and effectiveness analyses will include incidence of major stroke in the territory supplied by the treated artery or neurological death at 2- and 3-years post-procedure, incidence of major stroke in the territory supplied by the treated artery or neurological death at 30 days post-procedure, incidence of delayed intraparenchymal hemorrhage >30 days post-procedure through 1-year post-procedure, incidence of subjects with disabling strokes that have a mRS decline to a score of 3 or more (mRS ≥ 3) due to a stroke-related cause assessed at a minimum of 90 days post-stroke event at 1 year, 2 year, and 3 year post-procedure, incidence of successful device implantation at the target site, incidence of complete aneurysm occlusion (Raymond Roy Class 1) at 1- and 3-years post-procedure, incidence of target aneurysm recurrence at 1- and 3-years post-procedure.

Being tested
Pipeline™ Vantage Embolization Device with Shield Technology™
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™ Vantage Embolization Device with Shield Technology™Device

    Also called Pipeline™ Vantage

    Pipeline™ Vantage Embolization Device with Shield Technology™

Study groups in NCT03873714
Study groupRoleWhat they receive
Pipeline™ Vantage Embolization Device with Shield Technology™ExperimentalPipeline™ Vantage Embolization Device with Shield Technology™
Receives: Device: Pipeline™ Vantage Embolization Device with Shield Technology™

What is being measured

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

  1. Safety: Incidence of Major Stroke or Neurological Death

    Incidence of major stroke in the territory supplied by the treated artery or neurological death.

    Measured: 1 year post-procedure

  2. Effectiveness: Incidence of Complete Aneurysm Occlusion

    Incidence of complete aneurysm occlusion (Raymond Roy Scale Class 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm at 1-year post-procedure.

    Measured: 1 year post-procedure

Secondary outcomes (9)

  1. Effectiveness: Incidence of Successful Device Implantation

    Incidence of successful device implantation at the target site

    Measured: Day 0

  2. Effectiveness: Incidence of Complete Aneurysm Occlusion

    Incidence of complete aneurysm occlusion (Raymond Roy Class 1)

    Measured: 1 year post-procedure

  3. Effectiveness: Incidence of Target Aneurysm Recurrence

    Incidence of target aneurysm recurrence at 1 year post-procedure

    Measured: 1 year post-procedure

  4. Safety: Incidence of Major Stroke

    Incidence of major stroke in the territory supplied by the treated artery or neurological death

    Measured: 2 and 3 years post-procedure

  5. Safety: Incidence of Major Stroke

    Incidence of major stroke in the territory supplied by the treated artery or neurological death

    Measured: 30 days post-procedure

  6. Safety: Incidence of Delayed Intraparenchymal Hemorrhage

    Incidence of delayed intraparenchymal hemorrhage >30 days post-procedure through 1-year post-procedure

    Measured: >30 days post-procedure through 1 year post-procedure

  7. Safety: Incidence of Subjects With Disabling Strokes

    Incidence of subjects with disabling strokes that have a mRS decline to a score of 3 or more (mRS ≥ 3) due to a stroke-related cause assessed at a minimum of 90 days post-stroke event

    Measured: Assessed from procedure through 3 years post-procedure

  8. Effectiveness: Incidence of Complete Aneurysm Occlusion

    Incidence of complete aneurysm occlusion (Raymond Roy Class 1)

    Measured: 3 years post-procedure

  9. Effectiveness: Incidence of Target Aneurysm Recurrence

    Incidence of target aneurysm recurrence 3-years post-procedure

    Measured: 3 years post-procedure

Timeline

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

  1. First posted13 Mar 2019
  2. Study start2 Apr 2020
  3. Primary completion22 Jul 2021
  4. Study completion18 Sep 2023

Why it stopped: The study enrollment was halted on 14-Jun-2020. The study was not resumed and was terminated on 06-Jun-2024. Participants are no longer being examined or receiving intervention. Sponsor is no longer pursuing clinical evidence from the ADVANCE study.

Resources

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
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03873714
Sponsor's protocol ID
COVSHLD0569
Acronym
ADVANCE
Status last verified
Jun 2025
First submitted
26 Feb 2019
Last updated
19 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No individual participant data will be available.

Questions about this trial

What is this clinical trial studying?

A study testing Pipeline™ Vantage Embolization Device with Shield Technology™ in people with Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 3 sites in United States.

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 10 inclusion and 27 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: stopped early, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 5 Sep 2024). 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?

Safety: Incidence of Major Stroke or Neurological Death (time frame: 1 year 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 NCT03873714.

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 19 Jun 2025.

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ADVANCE Clinical Trial NCT03873714 | AzTrials