Pipeline™ Vantage Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms (ADVANCE) (ADVANCE)
Primary Purpose
Intracranial Aneurysm
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pipeline™ Vantage Embolization Device with Shield Technology™
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysm
Eligibility Criteria
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:
- 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
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:
- 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
Sites / Locations
- Baptist Medical Center Jacksonville
- Jackson Memorial Hospital
- Stony Brook University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pipeline™ Vantage Embolization Device with Shield Technology™
Arm Description
Pipeline™ Vantage Embolization Device with Shield Technology™
Outcomes
Primary Outcome Measures
Safety: Incidence of major stroke or neurological death
Incidence of major stroke in the territory supplied by the treated artery or neurological death.
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
Secondary Outcome Measures
Effectiveness: Incidence of successful device implantation
Incidence of successful device implantation at the target site
Effectiveness: Incidence of complete aneurysm occlusion
Incidence of complete aneurysm occlusion (Raymond Roy Class 1)
Effectiveness: Incidence of target aneurysm recurrence
Incidence of target aneurysm recurrence
Safety: Incidence of major stroke
Incidence of major stroke in the territory supplied by the treated artery or neurological death
Safety: Incidence of major stroke
Incidence of major stroke in the territory supplied by the treated artery or neurological death
Safety: Incidence of delayed intraparenchymal hemorrhage
Incidence of delayed intraparenchymal hemorrhage
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
Full Information
NCT ID
NCT03873714
First Posted
February 26, 2019
Last Updated
August 21, 2023
Sponsor
Medtronic Neurovascular Clinical Affairs
1. Study Identification
Unique Protocol Identification Number
NCT03873714
Brief Title
Pipeline™ Vantage Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms (ADVANCE)
Acronym
ADVANCE
Official Title
A Study of the Pipeline™ Vantage Embolization Device With Shield Technology™ for Endovascular Treatment of Wide-Necked Intracranial Aneurysms
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Neurovascular Clinical Affairs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pipeline™ Vantage Embolization Device with Shield Technology™
Arm Type
Experimental
Arm Description
Pipeline™ Vantage Embolization Device with Shield Technology™
Intervention Type
Device
Intervention Name(s)
Pipeline™ Vantage Embolization Device with Shield Technology™
Other Intervention Name(s)
Pipeline™ Vantage
Intervention Description
Pipeline™ Vantage Embolization Device with Shield Technology™
Primary Outcome Measure Information:
Title
Safety: Incidence of major stroke or neurological death
Description
Incidence of major stroke in the territory supplied by the treated artery or neurological death.
Time Frame
1 year post-procedure
Title
Effectiveness: Incidence of complete aneurysm occlusion
Description
Incidence of complete aneurysm occlusion (Raymond Roy Scale Class 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm
Time Frame
1 year post-procedure
Secondary Outcome Measure Information:
Title
Effectiveness: Incidence of successful device implantation
Description
Incidence of successful device implantation at the target site
Time Frame
Day 0
Title
Effectiveness: Incidence of complete aneurysm occlusion
Description
Incidence of complete aneurysm occlusion (Raymond Roy Class 1)
Time Frame
1 and 3 years post-procedure
Title
Effectiveness: Incidence of target aneurysm recurrence
Description
Incidence of target aneurysm recurrence
Time Frame
1 and 3 years post-procedure
Title
Safety: Incidence of major stroke
Description
Incidence of major stroke in the territory supplied by the treated artery or neurological death
Time Frame
2 and 3 years post-procedure
Title
Safety: Incidence of major stroke
Description
Incidence of major stroke in the territory supplied by the treated artery or neurological death
Time Frame
30 days post-procedure
Title
Safety: Incidence of delayed intraparenchymal hemorrhage
Description
Incidence of delayed intraparenchymal hemorrhage
Time Frame
>30 days post-procedure through 1 year post-procedure
Title
Safety: Incidence of subjects with disabling strokes
Description
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
Time Frame
1 year, 2 year, and 3 year post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Jabbour, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Demetrius Lopes, MD
Organizational Affiliation
Advocate Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Medical Center Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be available.
Learn more about this trial
Pipeline™ Vantage Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms (ADVANCE)
We'll reach out to this number within 24 hrs