Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
SURF
A Prospective, Multicenter Study Assessing the Embolization of Intracranial Aneurysms Using WAVE™ Extra Soft Coils, a Part of the Penumbra SMART COIL® System
1 other identifier
observational
572
6 countries
43
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Typical duration for all trials
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedStudy Start
First participant enrolled
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2023
CompletedResults Posted
Study results publicly available
March 4, 2025
CompletedMarch 4, 2025
February 1, 2025
3.7 years
September 25, 2019
November 21, 2024
February 10, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Efficacy: Adequate Occlusion
Adequate occlusion defined as Raymond-Roy Class I and II at final follow-up Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Through Study Completion, An Average of 1 Year
Safety: Serious Adverse Events (SAEs)
The primary safety endpoints are SAEs within 24 hours post-procedure
Up to 24 Hours Post-Procedure
Safety: Device-Related SAE
Device-related SAE up to 7 days or discharge
Through Discharge, up to 7 Days Post-Procedure
Secondary Outcomes (8)
Efficacy: Occlusion Rate
Immediate Post-Procedure
Efficacy: Retreatment Rate
Through Study Completion, An Average of 1 Year
Efficacy: Aneurysm Occlusion Raymond I
Immediate Post-Treatment
Efficacy: Aneurysm Occlusion Raymond I
Through Study Completion, An Average of 1 Year
Efficacy: Aneurysm Recanalization or Progressive Thrombosis
From Immediate Post Procedure Through Study Completion, An Average of 1 Year
- +3 more secondary outcomes
Study Arms (1)
Single Arm
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
Interventions
Eligibility Criteria
Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
You may qualify if:
- Patient age ≥ 18 years
- 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
You may not qualify if:
- Life expectancy less than 1 year
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penumbra Inc.lead
Study Sites (43)
Southeast Health Medical Center
Dothan, Alabama, 36301, United States
Banner UMC Tucson
Tucson, Arizona, 85719, United States
Sharp Grossmont
La Mesa, California, 91942, United States
Los Robles
Thousand Oaks, California, 91360, United States
HRI - Swedish
Englewood, Colorado, 80113, United States
St. Anthony's Hospital
Lakewood, Colorado, 80228, United States
Yale New Haven
New Haven, Connecticut, 06320, United States
University of Miami (Jackson Memorial)
Miami, Florida, 33136, United States
University of South Florida
Tampa, Florida, 33606, United States
Morton Plant
Tampa, Florida, 33756, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Amita Health
Joliet, Illinois, 60435, United States
Indiana University Health
Indianapolis, Indiana, 46202, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Metro Health
Wyoming, Michigan, 49519, United States
SSM Health Care
Bridgeton, Missouri, 63044, United States
Northwell Health
Manhasset, New York, 11030, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Vidant Medical Center
Greenville, North Carolina, 27834, United States
Mercy St. Vincent
Toledo, Ohio, 43608, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
UPenn
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
MUSC
Charleston, South Carolina, 29425, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
University of Tennessee Medical Center, Knoxville
Knoxville, Tennessee, 37996, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
McAllen Medical Center
McAllen, Texas, 78503, United States
Texas Stroke Institute - DFW
Plano, Texas, 75075, United States
Riverside Regional Medical Center
Newport News, Virginia, 23601, United States
Foothills Medical Center
Calgary, T2N 2T9, Canada
University Health Network
Toronto, M5T 2S8, Canada
Bremen-Mitte
Bremen, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
UKSH - Campus Lübeck
Lübeck, 23538, Germany
Maggiore della Carità
Novara, Italy
Vall d'Hebron
Barcelona, Spain
Donostia
San Sebastián, Spain
Universitätsspital Basel
Basel, Switzerland
Related Publications (1)
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.
PMID: 40908130DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brooke Lawson
- Organization
- Penumbra, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Clemens M Schirmer, MD
Geisinger Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2019
First Posted
September 27, 2019
Study Start
November 5, 2019
Primary Completion
August 2, 2023
Study Completion
August 2, 2023
Last Updated
March 4, 2025
Results First Posted
March 4, 2025
Record last verified: 2025-02