Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil (SMART)
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ClinicalTrials.gov Identifier: NCT02729740 |
Recruitment Status :
Completed
First Posted : April 6, 2016
Results First Posted : March 1, 2021
Last Update Posted : March 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intracranial Aneurysm | Device: Penumbra Smart Coil Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 995 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System |
Actual Study Start Date : | June 3, 2016 |
Actual Primary Completion Date : | December 27, 2019 |
Actual Study Completion Date : | December 27, 2019 |

Arm | Intervention/treatment |
---|---|
Penumbra Smart System |
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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Immediate Post Procedure ]
- Number of Participants Requiring Retreatment Through Follow-up [ Time Frame: One year from enrollment ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729740

Documents provided by Penumbra Inc.:
Responsible Party: | Penumbra Inc. |
ClinicalTrials.gov Identifier: | NCT02729740 |
Other Study ID Numbers: |
CLP 10023 |
First Posted: | April 6, 2016 Key Record Dates |
Results First Posted: | March 1, 2021 |
Last Update Posted: | March 1, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Penumbra Smart coils PC 400 AV malformations AV fistulae POD |
Intracranial Aneurysm Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |