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

NCT03873714 | Terminated Results DMC FDA Device

• 1 other identifier: COVSHLD0569
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (2)

• Safety: Incidence of Major Stroke or Neurological Death

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

  1 year post-procedure

• 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.

  1 year post-procedure

Secondary Outcomes (9)

• Effectiveness: Incidence of Successful Device Implantation

  Day 0

• Effectiveness: Incidence of Complete Aneurysm Occlusion

  1 year post-procedure

• Effectiveness: Incidence of Target Aneurysm Recurrence

  1 year post-procedure

• Safety: Incidence of Major Stroke

  2 and 3 years post-procedure

• Safety: Incidence of Major Stroke

  30 days post-procedure

Study Arms (1)

Pipeline™ Vantage Embolization Device with Shield Technology™

EXPERIMENTAL

Pipeline™ Vantage Embolization Device with Shield Technology™

Device: Pipeline™ Vantage Embolization Device with Shield Technology™

Interventions

Pipeline™ Vantage Embolization Device with Shield Technology™ DEVICE

Pipeline™ Vantage Embolization Device with Shield Technology™

Also known as: Pipeline™ Vantage

Pipeline™ Vantage Embolization Device with Shield Technology™

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead

Study Sites (3)

Baptist Medical Center Jacksonville

Jacksonville, Florida, 32207, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The study was put on enrollment hold on 14 Jun 2020. At that time, fourteen (14) subjects had been enrolled and seven (7) subjects had been treated with the study device. All treated subjects were followed per protocol through the 3-year follow-up assessment.

Results Point of Contact

• Title: Director, Global Clinical Research
• Organization: Medtronic Neurovascular

rs.advance@medtronic.com

949.837.3700

Study Officials

• Pascal Jabbour, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Demetrius Lopes, MD

  Advocate Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 13, 2019
• Study Start: April 2, 2020
• Primary Completion: July 22, 2021
• Study Completion: September 18, 2023
• Last Updated: June 19, 2025
• Results First Posted: September 5, 2024

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)