Wide-neck, Saccular Intracranial Aneurysms
Conditions
Keywords
wide-neck, saccular, intracranial aneurysms, ICA, Stent assisted coiling, Liberty Stent
Brief summary
To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck, saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath and a delivery wire assembly. The implant component is made of superelastic and biocompatible nitinol tubular material. Patients presenting with wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA) from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) will receive stent assisted coiling by the Penumbra Liberty Stent with any approved embolic coils currently on the market. Wide-neck aneurysms are defined by a neck ≥4mm or a dome-to-neck ratio \<2. Each patient will be followed and assessed for 2, 6 and 12 months after enrollment.
Interventions
DEVICEStent assisted coiling with the Liberty Stent
Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Sponsors
Penumbra Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years old * A wide-neck intracranial saccular aneurysm with a neck ≥ 4mm or a dome to neck ratio \<2 in the ICA from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) * Life expectancy \> 12 months * Signed Informed Consent
Exclusion criteria
* Females who are pregnant or intend to become pregnant during the study. (Females of child-bearing potential must have a urinary pregnancy test within 7 days of enrollment) * Extradural aneurysms * Known multiple untreated cerebral aneurysms at study entry * Recent history of subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment * Admission platelet \<50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR \>3.0 * Contraindication to angiography such as elevated creatinine or known allergy to angiographic contrast * Contraindication to CT and/or MRI scans * Known allergy to the metal component of the Penumbra Liberty Stent System * Evidence of active infection (WBC \>10x109 /L) * Any medical conditions that will not allow the necessary follow-up for this study (e.g., pre-existing neurological or psychiatric diseases) * Current substance-abuse /illicit drug use * Angiographic evidence of an arterial stenosis proximal to the target lesion that could prevent device deployment * Contraindications to study medications (heparin, aspirin, clopidogrel, and radiographic contrasts)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Raymond Class I Complete Obliteration at 12 Months | At 12 months post-implant | Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004). |
| Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment. | At 12 months post-implant | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Device Deployment Failures | During the procedure | Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm |
| Number of Device Migrations | 12 months post-implant | Migration is defined as movement of the Liberty stent by more than 5 mm as documented by the 12 month angiogram when compared to its immediate post-implant position. |
| Number of Participants With Aneurysm Raymond Class I Occlusion Grading | At 12 months post-implant | Raymond Class I Occlusion grading defined as complete obliteration of the aneurysm at 12 months. |
| Number of Intracranial Hemorrhages | At 12 months post-implant | Inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhages (symptomatic or asymptomatic). Symptomatic is defined as a 4 point or more increase in the National Institutes of Health Stroke Scale (NIHSS) from baseline. The NIHSS ranges from 1 to 42, with higher scores indicating greater severity of stroke. |
| Number of Ipsilateral Ischemic Strokes | At 12 months post-implant | Defined as episodes of focal or global neurological dysfunction due to brain or retinal infarction in the same hemisphere of the target aneurysm with signs and symptoms that persist for 24 hours or longer. When appropriate, non contrast CT scans will be used to eliminate hemorrhagic strokes |
| All Cause Mortality (Number of Deaths From Any Cause) | At 12 months post-implant | — |
| Number of Retreatments | At 12 months post-implant | Defined as any intervention after the completion of the initial stent assisted coiling procedure |
| Number of Participants Who Experienced Device Patency | at 12 months post-implant | Device patency (stenosis) at 12 months |
| Number of Participants Who Experienced Aneurysm Recanalization | At 12 months post-implant | — |
| Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2 | At 12 months post-implant | The Modified Rankin Scale measures functional ability on a scale from 0-5, with 0 indicating no symptoms at all and 5 indicating severe disability. |
| Number of Participants With Device-related Serious Adverse Events | During the procedure | The number of participants with device-related Serious Adverse Events as a measure of safety of the procedure and device. The FDA definitions for Serious Adverse Events are used. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liberty Stent Arm Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
Stent assisted coiling with the Liberty Stent: Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months | 112 |
| Total | 112 |
Baseline characteristics
| Characteristic | Liberty Stent Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 34 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants |
| BMI | 26.9 kg/m^2 |
| Race/Ethnicity, Customized Race American Indian | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 27 Participants |
| Race/Ethnicity, Customized Race Black | 17 Participants |
| Race/Ethnicity, Customized Race Caucasian | 61 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants |
| Race/Ethnicity, Customized Race Unknown | 4 Participants |
| Region of Enrollment Japan | 25 participants |
| Region of Enrollment United States | 95 participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 96 / 112 |
| serious Total, serious adverse events | 34 / 112 |
Outcome results
Primary
Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.
Time frame: At 12 months post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberty Stent Arm | Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment. | 3 Participants |
Primary
Number of Participants With Raymond Class I Complete Obliteration at 12 Months
Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004).
Time frame: At 12 months post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberty Stent Arm | Number of Participants With Raymond Class I Complete Obliteration at 12 Months | 98 Participants |
Secondary
All Cause Mortality (Number of Deaths From Any Cause)
Time frame: At 12 months post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberty Stent Arm | All Cause Mortality (Number of Deaths From Any Cause) | 0 Participants |
Secondary
Number of Device Deployment Failures
Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm
Time frame: During the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberty Stent Arm | Number of Device Deployment Failures | 5 Participants |
Secondary
Number of Device Migrations
Migration is defined as movement of the Liberty stent by more than 5 mm as documented by the 12 month angiogram when compared to its immediate post-implant position.
Time frame: 12 months post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberty Stent Arm | Number of Device Migrations | 0 Participants |
Secondary
Number of Intracranial Hemorrhages
Inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhages (symptomatic or asymptomatic). Symptomatic is defined as a 4 point or more increase in the National Institutes of Health Stroke Scale (NIHSS) from baseline. The NIHSS ranges from 1 to 42, with higher scores indicating greater severity of stroke.
Time frame: At 12 months post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberty Stent Arm | Number of Intracranial Hemorrhages | 2 Participants |
Secondary
Number of Ipsilateral Ischemic Strokes
Defined as episodes of focal or global neurological dysfunction due to brain or retinal infarction in the same hemisphere of the target aneurysm with signs and symptoms that persist for 24 hours or longer. When appropriate, non contrast CT scans will be used to eliminate hemorrhagic strokes
Time frame: At 12 months post-implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liberty Stent Arm | Number of Ipsilateral Ischemic Strokes | 8 participants |
Secondary
Number of Participants Who Experienced Aneurysm Recanalization
Time frame: At 12 months post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberty Stent Arm | Number of Participants Who Experienced Aneurysm Recanalization | 6 Participants |
Secondary
Number of Participants Who Experienced Device Patency
Device patency (stenosis) at 12 months
Time frame: at 12 months post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberty Stent Arm | Number of Participants Who Experienced Device Patency | 2 Participants |
Secondary
Number of Participants With Aneurysm Raymond Class I Occlusion Grading
Raymond Class I Occlusion grading defined as complete obliteration of the aneurysm at 12 months.
Time frame: At 12 months post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberty Stent Arm | Number of Participants With Aneurysm Raymond Class I Occlusion Grading | 99 Participants |
Secondary
Number of Participants With Device-related Serious Adverse Events
The number of participants with device-related Serious Adverse Events as a measure of safety of the procedure and device. The FDA definitions for Serious Adverse Events are used.
Time frame: During the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberty Stent Arm | Number of Participants With Device-related Serious Adverse Events | 17 Participants |
Secondary
Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2
The Modified Rankin Scale measures functional ability on a scale from 0-5, with 0 indicating no symptoms at all and 5 indicating severe disability.
Time frame: At 12 months post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberty Stent Arm | Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2 | 106 Participants |
Secondary
Number of Retreatments
Defined as any intervention after the completion of the initial stent assisted coiling procedure
Time frame: At 12 months post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberty Stent Arm | Number of Retreatments | 4 Participants |