Aneurysm, BrainSURFNCT04106583
Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
An observational study of Aneurysm, Brain, run by Penumbra Inc. at 43 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Brain
- What is being tested?
- WAVE, as part of the SMART COIL System
- Type of treatment
- Medical device
- How many people
- 572 participants
- Where
- 43 sitesin 6 countries
- Study dates
- 5 Nov 2019to 2 Aug 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
43 sites in 6 countries.
43 sites in 6 countries
United States34 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
SSM Health Care
Bridgeton, Missouri, 63044
MUSC
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
Baylor University Medical Center
Dallas, Texas, 75246
Geisinger Medical Center
Danville, Pennsylvania, 17822
Southeast Health Medical Center
Dothan, Alabama, 36301
HRI - Swedish
Englewood, Colorado, 80113
Vidant Medical Center
Greenville, North Carolina, 27834
Greenville Memorial Hospital
Greenville, South Carolina, 29605
Indiana University Health
Indianapolis, Indiana, 46202
Amita Health
Joliet, Illinois, 60435
University of Tennessee Medical Center, Knoxville
Knoxville, Tennessee, 37996
Sharp Grossmont
La Mesa, California, 91942
St. Anthony's Hospital
Lakewood, Colorado, 80228
Northwell Health
Manhasset, New York, 11030
McAllen Medical Center
McAllen, Texas, 78503
University of Miami (Jackson Memorial)
Miami, Florida, 33136
Yale New Haven
New Haven, Connecticut, 06320
Ochsner Medical Center
New Orleans, Louisiana, 70121
Mount Sinai Hospital
New York, New York, 10029
Riverside Regional Medical Center
Newport News, Virginia, 23601
University of Oklahoma
Oklahoma City, Oklahoma, 73104
UPenn
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Texas Stroke Institute - DFW
Plano, Texas, 75075
University of South Florida
Tampa, Florida, 33606
Morton Plant
Tampa, Florida, 33756
Los Robles
Thousand Oaks, California, 91360
Mercy St. Vincent
Toledo, Ohio, 43608
Banner UMC Tucson
Tucson, Arizona, 85719
Westchester Medical Center
Valhalla, New York, 10595
Metro Health
Wyoming, Michigan, 49519
Germany3 sites
Bremen-Mitte
Bremen
Klinikum Chemnitz gGmbH
Chemnitz, 09116
UKSH - Campus Lübeck
Lübeck, 23538
Canada2 sites
Foothills Medical Center
Calgary, T2N 2T9
University Health Network
Toronto, M5T 2S8
About this study
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
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
- Being tested
- WAVE, as part of the SMART COIL System
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAVE, as part of the SMART COIL SystemDevice
WAVE, as part of the SMART COIL System
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System Receives: Device: WAVE, as part of the SMART COIL System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through Study Completion, An Average of 1 Year
Safety: Serious Adverse Events (SAEs)
The primary safety endpoints are SAEs within 24 hours post-procedure
Measured: Up to 24 Hours Post-Procedure
Safety: Device-Related SAE
Device-related SAE up to 7 days or discharge
Measured: Through Discharge, up to 7 Days Post-Procedure
Secondary outcomes (8)
Efficacy: Occlusion Rate
Immediate post-procedure occlusion rates:
Class 1 - Complete occlusion Class 2 - Residual neck Class 3 - Residual aneurysm
The classification of angiographic results was adopted from Roy, Milot, and Raymond. Stroke 2001;32:1998-2004
Measured: Immediate Post-Procedure
Efficacy: Retreatment Rate
Retreatment rate at final follow-up
Measured: Through Study Completion, An Average of 1 Year
Efficacy: Aneurysm Occlusion Raymond I
Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Measured: Immediate Post-Treatment
Efficacy: Aneurysm Occlusion Raymond I
Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Measured: Through Study Completion, An Average of 1 Year
Efficacy: Aneurysm Recanalization or Progressive Thrombosis
Aneurysm recanalization or progressive thrombosis from post procedure to final follow-up
Measured: From Immediate Post Procedure Through Study Completion, An Average of 1 Year
Safety: Major Ipsilateral Stroke
Occurrence of Major Ipsilateral Stroke
Measured: Through Study Completion, An Average of 1 Year
Safety: Device-Related SAE
Device related SAE at final follow-up
Measured: Through Study Completion, An Average of 1 Year
Safety: Morbidity and Mortality
All-cause morbidity and mortality at final follow-up
Measured: Through Study Completion, An Average of 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start5 Nov 2019
- Primary completion2 Aug 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysm, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clemens M Schirmer, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106583
- Sponsor's protocol ID
- CLP 13669
- Acronym
- SURF
- Status last verified
- Feb 2025
- First submitted
- 25 Sep 2019
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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. 2026 Apr 16;18(5):1297-1303. doi: 10.1136/jnis-2025-023633.
PubMed 40908130
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04106583
- Acronym / sponsor ID
- SURF / CLP 13669
- Conditions
- Aneurysm, Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | Device: WAVE, as part of the SMART COIL SystemSingle Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WAVE, as part of the SMART COIL SystemWAVE, as part of the SMART COIL System | Device | Single Arm |
Primary outcome
Efficacy: Adequate Occlusion
Time frame: Through Study Completion, An Average of 1 Year
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.
Safety: Serious Adverse Events (SAEs)
Time frame: Up to 24 Hours Post-Procedure
The primary safety endpoints are SAEs within 24 hours post-procedure
Safety: Device-Related SAE
Time frame: Through Discharge, up to 7 Days Post-Procedure
Device-related SAE up to 7 days or discharge
8 secondary outcomes
Efficacy: Occlusion Rate
Time frame: Immediate Post-Procedure
Efficacy: Retreatment Rate
Time frame: Through Study Completion, An Average of 1 Year
Efficacy: Aneurysm Occlusion Raymond I
Time frame: Immediate Post-Treatment
Efficacy: Aneurysm Occlusion Raymond I
Time frame: Through Study Completion, An Average of 1 Year
Efficacy: Aneurysm Recanalization or Progressive Thrombosis
Time frame: From Immediate Post Procedure Through Study Completion, An Average of 1 Year
Safety: Major Ipsilateral Stroke
Time frame: Through Study Completion, An Average of 1 Year
Safety: Device-Related SAE
Time frame: Through Study Completion, An Average of 1 Year
Safety: Morbidity and Mortality
Time frame: Through Study Completion, An Average of 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40908130Schirmer 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. 2026 Apr 16;18(5):1297-1303. doi: 10.1136/jnis-2025-023633.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clemens M Schirmer, MD principal investigator
Geisinger Clinic
43 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm, Brain, run by Penumbra Inc. at 43 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Germany, Canada, Spain, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Adequate Occlusion (time frame: Through Study Completion, An Average of 1 Year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04106583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.