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Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil

NCT02729740 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 995

Last updated 2021-03-01

Study results available
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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.

Conditions

  • Intracranial Aneurysm

Interventions

DEVICE

Penumbra Smart Coil

DEVICE

Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)

Other Penumbra Coils available as standard of care

Sponsors & Collaborators

  • Penumbra Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-03
Primary Completion
2019-12-27
Completion
2019-12-27

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02729740 on ClinicalTrials.gov