Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
NCT ID: NCT04106583
Last Updated: 2025-03-04
Study Results
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View full resultsBasic Information
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COMPLETED
572 participants
OBSERVATIONAL
2019-11-05
2023-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single Arm
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
WAVE, as part of the SMART COIL System
WAVE, as part of the SMART COIL System
Interventions
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WAVE, as part of the SMART COIL System
WAVE, as part of the SMART COIL System
Eligibility Criteria
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Inclusion Criteria
* Patient having embolization of intracranial aneurysms
* WAVE Extra Soft Coil is final finishing coil
* Penumbra SMART COIL System accounts for at least 75% of total number of coils implanted
* Informed consent obtained per Institutional Review Board/Ethics Committee (IRB/EC) requirements
Exclusion Criteria
* Patient previously enrolled in the SURF Study
* Known multiple intracranial aneurysms requiring treatment during index procedure
* Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
* Participation in an interventional drug or device study that may confound the results of the study
18 Years
ALL
No
Sponsors
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Penumbra Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clemens M Schirmer, MD
Role: PRINCIPAL_INVESTIGATOR
Geisinger Clinic
Locations
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Southeast Health Medical Center
Dothan, Alabama, United States
Banner UMC Tucson
Tucson, Arizona, United States
Sharp Grossmont
La Mesa, California, United States
Los Robles
Thousand Oaks, California, United States
HRI - Swedish
Englewood, Colorado, United States
St. Anthony's Hospital
Lakewood, Colorado, United States
Yale New Haven
New Haven, Connecticut, United States
University of Miami (Jackson Memorial)
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Morton Plant
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Amita Health
Joliet, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Metro Health
Wyoming, Michigan, United States
SSM Health Care
Bridgeton, Missouri, United States
Northwell Health
Manhasset, New York, United States
Mount Sinai Hospital
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Vidant Medical Center
Greenville, North Carolina, United States
Mercy St. Vincent
Toledo, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
UPenn
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
MUSC
Charleston, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
University of Tennessee Medical Center, Knoxville
Knoxville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
McAllen Medical Center
McAllen, Texas, United States
Texas Stroke Institute - DFW
Plano, Texas, United States
Riverside Regional Medical Center
Newport News, Virginia, United States
Foothills Medical Center
Calgary, , Canada
University Health Network
Toronto, , Canada
Bremen-Mitte
Bremen, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
UKSH - Campus Lübeck
Lübeck, , Germany
Maggiore della Carità
Novara, , Italy
Vall d'Hebron
Barcelona, , Spain
Donostia
San Sebastián, , Spain
Universitätsspital Basel
Basel, , Switzerland
Countries
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References
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Schirmer CM, Yoo AJ, Spiotta AM, Kaminsky I, Alshekhlee A, Starke RM, Nicholson A, Zaidat OO, Bohnstedt B, Psychogios MN, Viets R, Asif KS, Stapleton CJ, Mitha AP, Goren O; SURF Study Investigators. Intracranial aneurysm embolization using Penumbra fill and finish coils: 1-year results of a prospective, real-world, multicenter SURF study. J Neurointerv Surg. 2025 Sep 4:jnis-2025-023633. doi: 10.1136/jnis-2025-023633. Online ahead of print.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLP 13669
Identifier Type: -
Identifier Source: org_study_id
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