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| ID | Type | Description | Link |
|---|---|---|---|
| CLP 4492 | Other Identifier | Penumbra Inc |
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This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long term follow-up to one year will be conducted in accordance to the standard of care at each participating hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embolization with the PC 400 coils | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PC 400 coils (Penumbra ) | Device | The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip. |
| Measure | Description | Time Frame |
|---|---|---|
| Packing Density With the Number of Coils Implanted | The data will be captured at the end of the coiling procedure which is standard for aneurysm studies. | At immediate post-procedure |
| Time of Fluoroscopic Exposure | The total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coiling procedure. | At immediate post-procedure |
| Procedural Device-related Serious Adverse Events | Procedural on-the-table serious adverse events will be captured and recorded at the end of the procedure. The duration of the procedure can be variable, depending on the time to access the target lesion and the time to complete the coiling procedure. | At immediate post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Occlusion of the Aneurysm Sac | Measured using Raymond Roy classification where grading ranges from I to III and higher values represent a worse outcome. | At immediate post-procedure |
| Intracranial Hemorrhage |
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Inclusion Criteria:
Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System which is for the endovascular embolization of:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siu P Sit, PhD | Penumbra Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Hospital | Newport Beach | California | 92658-6100 | United States | ||
| Rush University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Embolization With the PC 400 Coils | PC 400 coils (Penumbra ): The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Embolization With the PC 400 Coils | PC 400 coils (Penumbra ): The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Packing Density With the Number of Coils Implanted | The data will be captured at the end of the coiling procedure which is standard for aneurysm studies. | Posted | Mean | Standard Deviation | percentage of aneurysm volume | At immediate post-procedure |
|
up to 1 year in accordance to the standard of care at participating hospitals
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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 | Embolization With the PC 400 Coils | PC 400 coils (Penumbra ): The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michaella Corso | Penumbra, Inc. | 415-815-8904 | mcorso@penumbrainc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2011 | May 20, 2019 | Prot_SAP_000.pdf |
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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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|
| At discharge or 3 days post-procedure |
| Chicago |
| Illinois |
| 60612-3833 |
| United States |
| Mount Sinai School of Medicine | New York | New York | NY 10029 | United States |
| State University of New York Upstate Medical Center | Syracuse | New York | 13210 | United States |
| Fort Sanders Medical Center | Knoxville | Tennessee | 37916 | United States |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| years |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Time of Fluoroscopic Exposure | The total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coiling procedure. | The analysis population includes all intent-to-treat population. Procedural fluoroscopy time was available for 533 subjects. | Posted | Mean | Standard Deviation | minutes | At immediate post-procedure | lesions | lesions |
|
|
|
| Primary | Procedural Device-related Serious Adverse Events | Procedural on-the-table serious adverse events will be captured and recorded at the end of the procedure. The duration of the procedure can be variable, depending on the time to access the target lesion and the time to complete the coiling procedure. | Posted | Number | events | At immediate post-procedure |
|
|
|
| Secondary | Acute Occlusion of the Aneurysm Sac | Measured using Raymond Roy classification where grading ranges from I to III and higher values represent a worse outcome. | Posted | Number | participants | At immediate post-procedure |
|
|
|
| Secondary | Intracranial Hemorrhage | Posted | Number | events | At discharge or 3 days post-procedure |
|
|
|
| 32 |
| 517 |
| 126 |
| 517 |
| 284 |
| 517 |
| Cardiac Disorders | Cardiac disorders | Systematic Assessment |
|
| Congenital, familial, and genetic disorders | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Eye Disorders | Eye disorders | Systematic Assessment |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | Systematic Assessment |
|
| General Disorders and Administration Site Conditions | General disorders | Systematic Assessment |
|
| Hepatobiliary Disorders | Hepatobiliary disorders | Systematic Assessment |
|
| Infections and Infestations | Infections and infestations | Systematic Assessment |
|
| Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Investigations | Investigations | Systematic Assessment |
|
| Metabolism and Nutrition Disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neoplasms Benign, Malignant and Unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | Systematic Assessment |
|
| Psychiatric Disorders | Psychiatric disorders | Systematic Assessment |
|
| Renal and Urinary Disorders | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Surgical and Medical Procedures | Surgical and medical procedures | Systematic Assessment |
|
| Vascular Disorders | Vascular disorders | Systematic Assessment |
|
| Cardiac Disorders | Cardiac disorders | Systematic Assessment |
|
| Congenital, familial, and genetic disorders | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Ear and Labyrinth Disorders | Ear and labyrinth disorders | Systematic Assessment |
|
| Endocrine Disorders | Endocrine disorders | Systematic Assessment |
|
| Eye Disorders | Eye disorders | Systematic Assessment |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | Systematic Assessment |
|
| General Disorders and Administration Site Conditions | General disorders | Systematic Assessment |
|
| Hepatobiliary Disorders | Hepatobiliary disorders | Systematic Assessment |
|
| Immune System Disorders | Immune system disorders | Systematic Assessment |
|
| Infections and Infestations | Infections and infestations | Systematic Assessment |
|
| Injury, Poisoning, and Procedural Complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Investigations | Investigations | Systematic Assessment |
|
| Metabolism and Nutrition Disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Muskuloskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neoplasms Benign, Malignant, and Unspecified (inc cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | Systematic Assessment |
|
| Psychiatric Disorders | Psychiatric disorders | Systematic Assessment |
|
| Renal and Urinary Disorders | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin and Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Surgical and Medical Procedures | Surgical and medical procedures | Systematic Assessment |
|
| Vascular Disorders | Vascular disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
|