N/A
N=517
Study of the Penumbra Coil 400 System to Treat Aneurysm
Intracranial Aneurysms · Peripheral Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT01465841 ↗Enrolled (actual)
517
Serious AEs
24.4%
Results posted
Jul 2020
Primary outcome: Primary: Packing Density With the Number of Coils Implanted — 37.9 percentage of aneurysm volume
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PC 400 coils (Penumbra ) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Penumbra Inc.
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Packing Density With the Number of Coils Implanted |
37.9 | — |
| PRIMARY Time of Fluoroscopic Exposure |
38.2 | — |
| PRIMARY Procedural Device-related Serious Adverse Events |
12 | — |
| SECONDARY Acute Occlusion of the Aneurysm Sac |
214; 136; 115 | — |
| SECONDARY Intracranial Hemorrhage |
4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01465841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.