Intracranial Aneurysm
Conditions
Keywords
Penumbra Smart coils, PC 400, AV malformations, AV fistulae, POD
Brief summary
The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.
Detailed description
This is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart System (Smart), Penumbra Coil 400TM (PC 400), and Penumbra Occlusion Device (POD®). Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up. Approximately 1,000 patients with intracranial aneurysms or other malformations treated by the Smart System at up to 100 centers will be enrolled. It is anticipated patient enrollment will take 3 years. All patients are to be assessed in accordance with the standard of care at each participating hospital through one year follow-up.
Interventions
DEVICEPenumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
Other Penumbra Coils available as standard of care
DEVICEPenumbra Smart Coil
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 sign the Informed Consent Form and be treated according to the cleared indications for the Smart, PC 400, and POD, which include the embolization of: * Intracranial aneurysms * Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
Exclusion criteria
* Life expectancy less than one year * Smart, PC 400, or POD account for less than 75% of total number of coils implanted * Participation in another clinical investigation that could confound the evaluation of the registry device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Adequate Occlusion Immediate Post Procedure | Immediate Post Procedure | Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure. |
| Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout | Immediate Post Procedure | Re-access attempts due to catheter kick-out across all coils |
| Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure | Immediate Post Procedure | — |
| Number of Participants Requiring Retreatment Through Follow-up | One year from enrollment | — |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Penumbra Smart System Penumbra Smart Coil
Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care | 995 |
| Total | 995 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Early Termination | 130 |
| Overall Study | Other | 1 |
Baseline characteristics
| Characteristic | Penumbra Smart System |
|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 293 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants |
| Race (NIH/OMB) White | 256 Participants |
| Sex: Female, Male Female | 717 Participants |
| Sex: Female, Male Male | 278 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 60 / 995 |
| other Total, other adverse events | 90 / 995 |
| serious Total, serious adverse events | 277 / 995 |
Outcome results
Primary
Number of Participants Achieving Adequate Occlusion Immediate Post Procedure
Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.
Time frame: Immediate Post Procedure
Population: The analysis population (ITT) contains all 995 patients. 994 of 995 ITT patients have data on adequate occlusion at immediate post procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Penumbra Smart System | Number of Participants Achieving Adequate Occlusion Immediate Post Procedure | 965 Participants |
Primary
Number of Participants Requiring Retreatment Through Follow-up
Time frame: One year from enrollment
Population: The number of participants analyzed is different from overall as these were subjects that returned for follow-up in the intent to treat population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Penumbra Smart System | Number of Participants Requiring Retreatment Through Follow-up | 53 Participants |
Primary
Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure
Time frame: Immediate Post Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Penumbra Smart System | Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure | 26 Participants |
Primary
Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout
Re-access attempts due to catheter kick-out across all coils
Time frame: Immediate Post Procedure
Population: The analysis population is per device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Penumbra Smart System | Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout | 317 Coils |