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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Pipeline™ Vantage Embolization Device with Shield Technology™

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center Jacksonville
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (Imaging):

• 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.

Inclusion Criteria (Clinical):

• 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. For OUS sites, a Thromboelastogram (TEG) test may be carried out instead of the PRU test (depending on PRU test availability). In cases where TEG test is carried out, the subject should have a pre-procedure therapeutic ADP% between >30% to <90%.
• 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.

Exclusion Criteria (Imaging):

• 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:

  1. 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)
  2. PComm overlapping with the aneurysm neck
  3. 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

Exclusion Criteria (Clinical):

• 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:

  1. Active bacterial infection
  2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pipeline™ Vantage Embolization Device with Shield Technology™	Device: Pipeline™ Vantage Embolization Device with Shield Technology™; Pipeline™ Vantage Embolization Device with Shield Technology™; Other Names: Pipeline™ Vantage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness: Incidence of successful device implantation	Incidence of successful device implantation at the target site	Day 0
Effectiveness: Incidence of complete aneurysm occlusion	Incidence of complete aneurysm occlusion (Raymond Roy Class 1)	1 and 3 years post-procedure
Effectiveness: Incidence of target aneurysm recurrence	Incidence of target aneurysm recurrence	1 and 3 years post-procedure
Safety: Incidence of major stroke	Incidence of major stroke in the territory supplied by the treated artery or neurological death	2 and 3 years post-procedure
Safety: Incidence of major stroke	Incidence of major stroke in the territory supplied by the treated artery or neurological death	30 days post-procedure
Safety: Incidence of delayed intraparenchymal hemorrhage	Incidence of delayed intraparenchymal hemorrhage	>30 days post-procedure through 1 year post-procedure
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	1 year, 2 year, and 3 year post-procedure

Collaborators and Investigators

• Sponsor: Medtronic Neurovascular Clinical Affairs
• Investigators: Principal Investigator: Pascal Jabbour, MD, Thomas Jefferson University; Principal Investigator: Demetrius Lopes, MD, Advocate Health

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2020
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: COVSHLD0569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes