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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberty Stent arm | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent assisted coiling with the Liberty Stent | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 12 months post-implant |
| Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment. | At 12 months post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 12 months post-implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Demtrius Lopes, MD | Rush University Medical Center | Principal Investigator |
| Henry Woo, MD | Stony Brook University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Medical Center | Denver | Colorado | 80112 | United States | ||
| Rush University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | At 12 months post-implant |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous System Disorders | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous System Disorders | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michaella Corso | Penumbra, Inc. | (510) 748-3200 |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. | During the procedure |
| Number of Device Deployment Failures | Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm | During the procedure |
| 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. | 12 months post-implant |
| 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. | At 12 months post-implant |
| 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. | At 12 months post-implant |
| 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. | At 12 months post-implant |
| All Cause Mortality (Number of Deaths From Any Cause) | At 12 months post-implant |
| Number of Retreatments | Defined as any intervention after the completion of the initial stent assisted coiling procedure | At 12 months post-implant |
| Number of Participants Who Experienced Device Patency | Device patency (stenosis) at 12 months | at 12 months post-implant |
| Number of Participants Who Experienced Aneurysm Recanalization | At 12 months post-implant |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794-8122 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| Participants |
|
|
| Primary | Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment. | Posted | Count of Participants | Participants | At 12 months post-implant |
|
|
|
| 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 | Posted | Number | participants | At 12 months post-implant |
|
|
|
| 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. | Posted | Count of Participants | Participants | During the procedure |
|
|
|
| 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 | Posted | Count of Participants | Participants | During the procedure |
|
|
|
| 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. | Posted | Count of Participants | Participants | 12 months post-implant |
|
|
|
| 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. | Posted | Count of Participants | Participants | At 12 months post-implant |
|
|
|
| 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. | Posted | Count of Participants | Participants | At 12 months post-implant |
|
|
|
| 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. | Posted | Count of Participants | Participants | At 12 months post-implant |
|
|
|
| Secondary | All Cause Mortality (Number of Deaths From Any Cause) | Posted | Count of Participants | Participants | At 12 months post-implant |
|
|
|
| Secondary | Number of Retreatments | Defined as any intervention after the completion of the initial stent assisted coiling procedure | Posted | Count of Participants | Participants | At 12 months post-implant |
|
|
|
| Secondary | Number of Participants Who Experienced Device Patency | Device patency (stenosis) at 12 months | Posted | Count of Participants | Participants | at 12 months post-implant |
|
|
|
| Secondary | Number of Participants Who Experienced Aneurysm Recanalization | Posted | Count of Participants | Participants | At 12 months post-implant |
|
|
|
| 34 |
| 112 |
| 96 |
| 112 |
| Infections and Infestations | Infections and infestations | Systematic Assessment |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | Systematic Assessment |
|
| General Disorders | General disorders | Systematic Assessment |
|
| Cardiac Disorders | Cardiac disorders | Systematic Assessment |
|
| Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Blood and Lymphatic System Disorders | Blood and lymphatic system disorders | Systematic Assessment |
|
| Eye Disorders | Eye disorders | Systematic Assessment |
|
| Neoplasms, benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Vascular Disorders | Vascular disorders | Systematic Assessment |
|
| Hepatobiliary Disorders | Hepatobiliary disorders | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Psychiatric Disorders | Psychiatric disorders | Systematic Assessment |
|
| Respiratory, Thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| General Disorders | General disorders | Systematic Assessment |
|
| Infections and Infestations | Infections and infestations | Systematic Assessment |
|
| Eye Disorders | Eye disorders | Systematic Assessment |
|
| Vascular Disorders | Vascular disorders | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Injury, poisoning, and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Muskuloskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
|
| Immune System Disorders | Immune system disorders | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
|
| Ear and labyrinth disorders | Ear and labyrinth disorders | Systematic Assessment |
|
| Investigations | Investigations | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | Systematic Assessment |
|
| Endrocrine disorders | Endocrine disorders | Systematic Assessment |
|
| Psychiatric Disorders | Psychiatric disorders | Systematic Assessment |
|
| Surgical and Medical Procedures | Surgical and medical procedures | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |