Intracranial Aneurysms, Peripheral Aneurysms
Conditions
Keywords
intracranial aneurysms, Peripheral aneurysms, acute treatment, PC 400 System, packing density
Brief summary
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.
Interventions
DEVICEPC 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.
Sponsors
Penumbra Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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: * Intracranial aneurysms * Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae * Arterial and venous embolizations in the peripheral vasculature
Exclusion criteria
* Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Packing Density With the Number of Coils Implanted | At immediate post-procedure | The data will be captured at the end of the coiling procedure which is standard for aneurysm studies. |
| Time of Fluoroscopic Exposure | At immediate post-procedure | 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. |
| Procedural Device-related Serious Adverse Events | At immediate post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Occlusion of the Aneurysm Sac | At immediate post-procedure | Measured using Raymond Roy classification where grading ranges from I to III and higher values represent a worse outcome. |
| Intracranial Hemorrhage | At discharge or 3 days post-procedure | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 517 |
| Total | 517 |
Baseline characteristics
| Characteristic | Embolization With the PC 400 Coils | — |
|---|---|---|
| Age, Continuous | 58.8 Years STANDARD_DEVIATION 14.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 365 Participants | — |
| Sex: Female, Male Male | 152 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 32 / 517 |
| other Total, other adverse events | 284 / 517 |
| serious Total, serious adverse events | 126 / 517 |
Outcome results
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.
Time frame: At immediate post-procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization With the PC 400 Coils | Packing Density With the Number of Coils Implanted | 37.9 percentage of aneurysm volume | Standard Deviation 15.9 |
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.
Time frame: At immediate post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Embolization With the PC 400 Coils | Procedural Device-related Serious Adverse Events | 12 events |
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.
Time frame: At immediate post-procedure
Population: The analysis population includes all intent-to-treat population. Procedural fluoroscopy time was available for 533 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Embolization With the PC 400 Coils | Time of Fluoroscopic Exposure | 38.2 minutes | Standard Deviation 28.9 |
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.
Time frame: At immediate post-procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Embolization With the PC 400 Coils | Acute Occlusion of the Aneurysm Sac | Raymond-Roy Occlusion Class I | 214 participants |
| Embolization With the PC 400 Coils | Acute Occlusion of the Aneurysm Sac | Raymond-Roy Occlusion Class II | 136 participants |
| Embolization With the PC 400 Coils | Acute Occlusion of the Aneurysm Sac | Raymond-Roy Occlusion Class III | 115 participants |
Secondary
Intracranial Hemorrhage
Time frame: At discharge or 3 days post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Embolization With the PC 400 Coils | Intracranial Hemorrhage | 4 events |