Intracranial Aneurysm
Conditions
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.
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.
Interventions
DEVICEPipeline™ Vantage Embolization Device with Shield Technology™
Pipeline™ Vantage Embolization Device with Shield Technology™
Sponsors
Medtronic Neurovascular Clinical Affairs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Incidence of Major Stroke or Neurological Death | 1 year post-procedure | Incidence of major stroke in the territory supplied by the treated artery or neurological death. |
| Effectiveness: Incidence of Complete Aneurysm Occlusion | 1 year post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: Incidence of Target Aneurysm Recurrence | 1 year post-procedure | Incidence of target aneurysm recurrence at 1 year post-procedure |
| Safety: Incidence of Major Stroke | 2 and 3 years post-procedure | Incidence of major stroke in the territory supplied by the treated artery or neurological death |
| Effectiveness: Incidence of Successful Device Implantation | Day 0 | Incidence of successful device implantation at the target site |
| Safety: Incidence of Subjects With Disabling Strokes | Assessed from procedure through 3 years 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 |
| Safety: Incidence of Delayed Intraparenchymal Hemorrhage | >30 days post-procedure through 1 year post-procedure | Incidence of delayed intraparenchymal hemorrhage \>30 days post-procedure through 1-year post-procedure |
| Effectiveness: Incidence of Complete Aneurysm Occlusion | 1 year post-procedure | Incidence of complete aneurysm occlusion (Raymond Roy Class 1) |
Countries
United States
Participant flow
Recruitment details
The study was placed on an enrollment hold on 14 June 2020.
Pre-assignment details
A total of 14 subjects were enrolled, of which seven (7) subjects were treated, six (6) subjects were withdrawn, and one (1) subject was a Screen Failure.
Participants by arm
| Arm | Count |
|---|---|
| Study Group Pipeline™ Vantage Embolization Device with Shield Technology™ | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Six (6) were withdrawn, and one (1) was a Screen Failure | 7 |
Baseline characteristics
| Characteristic | Study Group | — |
|---|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 14.57 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 7 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 6 / 7 |
| serious Total, serious adverse events | 2 / 7 |
Outcome results
Primary
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.
Time frame: 1 year post-procedure
Population: All consented subjects in whom deployment of the Pipeline™ Vantage device was attempted. Population data is inadequate for a complete primary effectiveness endpoint evaluation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Effectiveness: Incidence of Complete Aneurysm Occlusion | 6 Participants |
Primary
Safety: Incidence of Major Stroke or Neurological Death
Incidence of major stroke in the territory supplied by the treated artery or neurological death.
Time frame: 1 year post-procedure
Population: All consented subjects in whom deployment of the Pipeline™ Vantage device was attempted
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Safety: Incidence of Major Stroke or Neurological Death | 1 Participants |
Secondary
Effectiveness: Incidence of Complete Aneurysm Occlusion
Incidence of complete aneurysm occlusion (Raymond Roy Class 1)
Time frame: 3 years post-procedure
Population: Subject that did not have complete occlusion at 1 year.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Effectiveness: Incidence of Complete Aneurysm Occlusion | 0 Participants |
Secondary
Effectiveness: Incidence of Complete Aneurysm Occlusion
Incidence of complete aneurysm occlusion (Raymond Roy Class 1)
Time frame: 1 year post-procedure
Population: Subjects treated with Pipeline™ Vantage Embolization Device with Shield Technology™
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Effectiveness: Incidence of Complete Aneurysm Occlusion | 6 Participants |
Secondary
Effectiveness: Incidence of Successful Device Implantation
Incidence of successful device implantation at the target site
Time frame: Day 0
Population: All Pipeline™ Vantage devices with deployment attempted
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Study Group | Effectiveness: Incidence of Successful Device Implantation | 9 Devices |
Secondary
Effectiveness: Incidence of Target Aneurysm Recurrence
Incidence of target aneurysm recurrence 3-years post-procedure
Time frame: 3 years post-procedure
Population: Subjects treated with Pipeline™ Vantage Embolization Device with Shield Technology™
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Effectiveness: Incidence of Target Aneurysm Recurrence | 0 Participants |
Secondary
Effectiveness: Incidence of Target Aneurysm Recurrence
Incidence of target aneurysm recurrence at 1 year post-procedure
Time frame: 1 year post-procedure
Population: Subjects treated with Pipeline™ Vantage Embolization Device with Shield Technology™
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Effectiveness: Incidence of Target Aneurysm Recurrence | 0 Participants |
Secondary
Safety: Incidence of Delayed Intraparenchymal Hemorrhage
Incidence of delayed intraparenchymal hemorrhage \>30 days post-procedure through 1-year post-procedure
Time frame: >30 days post-procedure through 1 year post-procedure
Population: All consented subjects in whom deployment of the Pipeline™ Vantage device was attempted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Safety: Incidence of Delayed Intraparenchymal Hemorrhage | 0 Participants |
Secondary
Safety: Incidence of Major Stroke
Incidence of major stroke in the territory supplied by the treated artery or neurological death
Time frame: 30 days post-procedure
Population: All consented subjects in whom deployment of the Pipeline™ Vantage device was attempted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Safety: Incidence of Major Stroke | 1 Participants |
Secondary
Safety: Incidence of Major Stroke
Incidence of major stroke in the territory supplied by the treated artery or neurological death
Time frame: 2 and 3 years post-procedure
Population: Subjects treated with Pipeline™ Vantage Embolization Device with Shield Technology™
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Safety: Incidence of Major Stroke | 0 Participants |
Secondary
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
Time frame: Assessed from procedure through 3 years post-procedure
Population: Subjects treated with Pipeline™ Vantage Embolization Device with Shield Technology™
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Safety: Incidence of Subjects With Disabling Strokes | 1 Participants |