An interventional study of Penumbra Smart Coil and Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD) in Intracranial Aneurysm, sponsored by Penumbra Inc.. Completed at 72 sites in 2 countries. Per ClinicalTrials.gov, last updated 2021-03-01.
Sponsored by Penumbra Inc. · Not applicable, Interventional, and Treatment
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.
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.
426 studies on the registry are indexed under Intracranial Aneurysm; 114 are open to participants now.
This study's enrollment of 995 is above the median of 115 across 206 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Penumbra Inc. is the lead sponsor of 33 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Device: Penumbra Smart Coil · Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
Other Penumbra Coils available as standard of care
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
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
Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure
Time frame: Immediate Post Procedure
Number of Participants Requiring Retreatment Through Follow-up
Time frame: One year from enrollment
| Milestone | Penumbra Smart System |
|---|---|
| Started | 995 |
| Completed | 864 |
| Not completed | 131 |
| Withdrew: Early termination | 130 |
| Withdrew: Other | 1 |
Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.
| Participants | Penumbra Smart System |
|---|---|
| Number of Participants Achieving Adequate Occlusion Immediate Post Procedure | 965 |
Re-access attempts due to catheter kick-out across all coils
| Coils | Penumbra Smart System |
|---|---|
| Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout | 317 |
| Participants | Penumbra Smart System |
|---|---|
| Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure | 26 |
| Participants | Penumbra Smart System |
|---|---|
| Number of Participants Requiring Retreatment Through Follow-up | 53 |
Collected over 1 year. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Penumbra Smart System | 60/995 (6%) | 277/995 (27.8%) | 90/995 (9%) |
| Event | Penumbra Smart System |
|---|---|
| HydrocephalusNervous system disorders | 23/995 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 17/995 |
| Cerebral vasoconstrictionNervous system disorders | 14/995 |
| Subarachnoid haemorrhageInjury, poisoning and procedural complications | 13/995 |
| HeadacheNervous system disorders | 13/995 |
| Cerebrovascular accidentNervous system disorders | 12/995 |
| Ischaemic strokeNervous system disorders | 12/995 |
| PneumoniaInfections and infestations | 11/995 |
| SeizureNervous system disorders | 10/995 |
| VasospasmVascular disorders | 10/995 |
| Event | Penumbra Smart System |
|---|---|
| Nervous system disordersNervous system disorders | 65/995 |
| Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications | 30/995 |
| Age, Continuous(years) | Penumbra Smart System |
|---|---|
| Mean | 59.6 ± 13 |
| Sex: Female, Male(Participants) | Penumbra Smart System |
|---|---|
| Female | 717 |
| Male | 278 |
| Ethnicity (NIH/OMB)(Participants) | Penumbra Smart System |
|---|---|
| Hispanic or Latino | 33 |
| Not Hispanic or Latino | 293 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Penumbra Smart System |
|---|---|
| American Indian or Alaska Native | 4 |
| Asian | 6 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 43 |
| White | 256 |
| More than one race | 0 |
| Unknown or Not Reported | 17 |
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Plan to share: No
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Penumbra Inc.