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Completed No phase listed Observational Results available

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

ClinicalTrials.gov ID: NCT04106583

Public ClinicalTrials.gov record NCT04106583. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 11:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Multicenter Study Assessing the Embolization of Intracranial Aneurysms Using WAVE™ Extra Soft Coils, a Part of the Penumbra SMART COIL® System

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04106583
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Penumbra Inc.
Industry
Enrollment
572 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 5, 2019 (Actual)
Primary completion
Aug 2, 2023 (Actual)
Completion
Aug 2, 2023 (Actual)
Last update posted
Mar 4, 2025

2019 – 2023

United States locations

U.S. sites
34
U.S. states
21
U.S. cities
32
Facility City State ZIP Site status
Southeast Health Medical Center Dothan Alabama 36301 —
Banner UMC Tucson Tucson Arizona 85719 —
Sharp Grossmont La Mesa California 91942 —
Los Robles Thousand Oaks California 91360 —
HRI - Swedish Englewood Colorado 80113 —
St. Anthony's Hospital Lakewood Colorado 80228 —
Yale New Haven New Haven Connecticut 06320 —
University of Miami (Jackson Memorial) Miami Florida 33136 —
University of South Florida Tampa Florida 33606 —
Morton Plant Tampa Florida 33756 —
Rush University Medical Center Chicago Illinois 60612 —
Amita Health Joliet Illinois 60435 —
Indiana University Health Indianapolis Indiana 46202 —
Ochsner Medical Center New Orleans Louisiana 70121 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
Metro Health Wyoming Michigan 49519 —
SSM Health Care Bridgeton Missouri 63044 —
Northwell Health Manhasset New York 11030 —
Mount Sinai Hospital New York New York 10029 —
Westchester Medical Center Valhalla New York 10595 —
Vidant Medical Center Greenville North Carolina 27834 —
Mercy St. Vincent Toledo Ohio 43608 —
University of Oklahoma Oklahoma City Oklahoma 73104 —
Geisinger Medical Center Danville Pennsylvania 17822 —
UPenn Philadelphia Pennsylvania 19104 —
Allegheny General Hospital Pittsburgh Pennsylvania 15212 —
MUSC Charleston South Carolina 29425 —
Greenville Memorial Hospital Greenville South Carolina 29605 —
University of Tennessee Medical Center, Knoxville Knoxville Tennessee 37996 —
Baylor University Medical Center Dallas Texas 75246 —
McAllen Medical Center McAllen Texas 78503 —
Texas Stroke Institute - DFW Plano Texas 75075 —
Riverside Regional Medical Center Newport News Virginia 23601 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04106583, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 4, 2025 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04106583 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →