N/A
Completed N=995
Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
Source: ClinicalTrials.gov NCT02729740 ↗Enrolled (actual)
995
Serious AEs
27.8%
Results posted
Mar 2021
Primary outcomePrimary: Number of Participants Achieving Adequate Occlusion Immediate Post Procedure — 965 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Adequate Occlusion Immediate Post Procedure |
965 | — |
| PRIMARY Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout |
317 | — |
| PRIMARY Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure |
26 | — |
| PRIMARY Number of Participants Requiring Retreatment Through Follow-up |
53 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02729740). 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. Informational only — not medical advice.