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Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities

NCT04106583 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 572

Last updated 2025-03-04

Study results available
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Summary

The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms. Imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates and perform a comparative analysis between imaging modalities.

Conditions

  • Aneurysm, Brain

Interventions

DEVICE

WAVE, as part of the SMART COIL System

WAVE, as part of the SMART COIL System

Sponsors & Collaborators

  • Penumbra Inc.

    lead INDUSTRY

Principal Investigators

  • Clemens M Schirmer, MD · Geisinger Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2023-08-02
Completion
2023-08-02
FDA Device
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Spain
  • Switzerland

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 NCT04106583 on ClinicalTrials.gov