Intracranial Aneurysm
Conditions
Brief summary
This is a prospective, single-arm, multi-center post-market observational study assessing the performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects undergoing treatment for intracranial aneurysms in a large real-world, post-market setting.
Detailed description
Eligible subjects will be treated with the Pipeline™ Flex Embolization Device with Shield Technology™. Subjects will undergo standard of care follow-up visits. Data generated per standard of care will be collected for 1 year beyond the index procedure. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Interventions
Pipeline™ Flex Embolization Device with Shield Technology™ utilizes a phosphorylcholine (PC) surface treatment to the implant combined with the PFED delivery system. The Shield Technology™ surface treatment applied to the implant is an inert polymer material created to mimic the outer membrane of a human red blood cell. The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for endovascular embolization of cerebral aneurysms and is designed to be placed across the opening (or 'neck') of a brain aneurysm and redirect blood flow away from the aneurysm, causing the blood within the aneurysm to clot.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Medtronic Neurovascular Clinical Affairs
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has provided written Data Release Form (DRF) or informed consent using the Institutional Review Board (IRB)/ Ethic Committee (EC)-approved consent form and agrees to comply with protocol requirements. * At least 18 years of age. * Subject has already been selected for flow diversion therapy as the appropriate treatment. * Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA.
Exclusion criteria
* Major surgery including endovascular procedures within the past 30 days. * Subject with target IA located in the basilar artery * Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy. * Stent is in place in the parent artery at the target IA location. * Subject with an acutely (within 30 days) ruptured aneurysm with a Hunt and Hess grade of 4 or higher. * Any known contraindication to treatment with the Pipeline™ Flex Embolization Device with Shield Technology™ per Instructions for Use. * 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, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment. * Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation. * Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from Medtronic. * Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Stroke/Death Occurrence | 1 year | Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death post-procedure (1-year) |
| Effectiveness - Aneurysm Occlusion | 1 year | Percentage (%) of Participants who have achieved complete aneurysm occlusion (defined as Raymond-Roy grade 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm post-procedure (1-year) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Stroke/Death Occurrence - 30 Days | 30 days | Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death at 30 days post-procedure due to procedural complications |
| Safety - Intracerebral Hemorrhage (ICH) | 1 year | Percentage (%) of Participants who experienced a delayed intracerebral hemorrhage \> 30 days post-procedure |
| Effectiveness - Deployment Rate | 1 year | Percentage (%) of Participants who have had a successful deployment of the device at the target site. A device is considered properly deployed when it covers the entire length of the aneurysm neck. |
Countries
Australia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Spain, United Kingdom
Participant flow
Recruitment details
Patients have been enrolled in 21 sites in EU, Australia and Israel between 24-Mar-2016 and 27-Sep-2017.
Participants by arm
| Arm | Count |
|---|---|
| Intention to Treat (ITT) Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population. | 204 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Implant Failure | 4 |
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Intention to Treat (ITT) | — |
|---|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 12.81 | — |
| Age, Customized ≤60 years | 134 Participants | — |
| Age, Customized > 60 years | 70 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 30 participants | — |
| Region of Enrollment Denmark | 3 participants | — |
| Region of Enrollment Finland | 9 participants | — |
| Region of Enrollment France | 1 participants | — |
| Region of Enrollment Germany | 23 participants | — |
| Region of Enrollment Greece | 21 participants | — |
| Region of Enrollment Hungary | 5 participants | — |
| Region of Enrollment Israel | 5 participants | — |
| Region of Enrollment Italy | 26 participants | — |
| Region of Enrollment Spain | 54 participants | — |
| Region of Enrollment United Kingdom | 27 participants | — |
| Sex: Female, Male Female | 166 Participants | — |
| Sex: Female, Male Male | 38 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 204 |
| other Total, other adverse events | 74 / 204 |
| serious Total, serious adverse events | 44 / 204 |
Outcome results
Primary
Effectiveness - Aneurysm Occlusion
Percentage (%) of Participants who have achieved complete aneurysm occlusion (defined as Raymond-Roy grade 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm post-procedure (1-year)
Time frame: 1 year
Population: Primary effectiveness endpoint was analyzed specifically on subjects with successful device implantation (FAS population, N=200).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intention to Treat (ITT) | Effectiveness - Aneurysm Occlusion | 71.67 percentage of patients |
Primary
Safety - Stroke/Death Occurrence
Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death post-procedure (1-year)
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intention to Treat (ITT) | Safety - Stroke/Death Occurrence | 3.23 percentage of patients with event |
Comparison: The primary safety objective was to determine if the 2-sided 95% upper confidence interval of the primary safety endpoint was below the threshold of 15%. Missing safety data for subjects who were lost to FU without any evidence of a major stroke/death were imputed in the analysis using multiple imputation. Subjects who withdrew from the study prior to completion and had experienced a major stroke or death were counted towards the primary safety endpoint as having experienced the event.p-value: <0.001Clopper-Pearson
Secondary
Effectiveness - Deployment Rate
Percentage (%) of Participants who have had a successful deployment of the device at the target site. A device is considered properly deployed when it covers the entire length of the aneurysm neck.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intention to Treat (ITT) | Effectiveness - Deployment Rate | 200 Participants |
Secondary
Safety - Intracerebral Hemorrhage (ICH)
Percentage (%) of Participants who experienced a delayed intracerebral hemorrhage \> 30 days post-procedure
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intention to Treat (ITT) | Safety - Intracerebral Hemorrhage (ICH) | 0 Participants |
Secondary
Safety - Stroke/Death Occurrence - 30 Days
Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death at 30 days post-procedure due to procedural complications
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intention to Treat (ITT) | Safety - Stroke/Death Occurrence - 30 Days | 6 Participants |