Intracranial AneurysmSMARTNCT02729740
Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
A study testing Penumbra Smart Coil and Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD) in people with Intracranial Aneurysm, run by Penumbra Inc. at 72 sites in 2 countries.
Trial summary
The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Penumbra Smart Coil and Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 995 participants
- Where
- 72 sitesin 2 countries
- Study dates
- 3 Jun 2016to 27 Dec 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients enrolled in this study must sign the Informed Consent Form and be treated according to the cleared indications for the Smart, PC 400, and POD, which include the embolization of:
- Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
Who cannot join
- Life expectancy less than one year
- Smart, PC 400, or POD account for less than 75% of total number of coils implanted
- Participation in another clinical investigation that could confound the evaluation of the registry device
Trial locations and contacts
72 sites in 2 countries.
72 sites in 2 countries
United States71 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
University of Colorado
Aurora, Colorado, 80045
Overlake Hospital
Bellevue, Washington, 98004
St. Alphonsus Regional Medical Center
Boise, Idaho, 83706
Kaleida Health
Buffalo, New York, 14210
MUSC
Charleston, South Carolina, 29425
Dept. of Neurosurgery, Univ of VA School of Medicine
Charlottesville, Virginia, 229808
Erlanger Health System, University of TN College of Medicine
Chattanooga, Tennessee, 37403
Northwestern Memorial
Chicago, Illinois, 60611
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Palmetto Health
Columbia, South Carolina, 29203
Geisinger Medical Center
Danville, Pennsylvania, 17822
Southeast Alabama Medical Center
Dothan, Alabama, 36301
RIA - Swedish Medical Center
Englewood, Colorado, 80112
North Shore University
Evanston, Illinois, 60631
SSM Health Care
Fenton, Missouri, 63026
Community Regional
Fresno, California, 93721
Lawnwood Regional Medical Center
Ft. Pierce, Florida, 34950
Valley Baptist Medical Center
Harlingen, Texas, 78550
Hershey's Medical Center
Hershey, Pennsylvania, 17033
CARE - Palmetto
Hialeah, Florida, 33016
Memorial Healthcare System
Hollywood, Florida, 33021
Houston Methodist
Houston, Texas, 77030
St. Mary's Medical Center
Huntington, West Virginia, 25702
Baptist Medical Center
Jacksonville, Florida, 32207
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
UHS Wilson Medical Center
Johnson City, New York, 13790
KUMC
Kansas City, Kansas, 66160
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
St. Anthony's Hospital
Lakewood, Colorado, 80228
Loma Linda Medical Center
Loma Linda, California, 92354
University of Louisville
Louisville, Kentucky, 40292
Northshore
Manhasset, New York, 11030
WellStar Kennestone Hospital
Marietta, Georgia, 30060
Methodist
Memphis, Tennessee, 38104
Baptist Hospital
Memphis, Tennessee, 38120
Banner Desert Medical Center
Mesa, Arizona, 85202
Jackson Memorial
Miami, Florida, 33136
Mt. Sinai Miami
Miami, Florida, 33140
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
HCMC
Minneapolis, Minnesota, 55415
UM-Fairview
Minneapolis, Minnesota, 55455
West Virginia University Hospital
Morgantown, West Virginia, 26506
Faxton St. Luke's Hospital
New Hartford, New York, 13502
Mount Sinai
New York, New York, 10029
Weill Cornell Medicine
New York, New York, 10065
Christiana Health
Newark, Delaware, 19713
OUHSC
Oklahoma City, Oklahoma, 73104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19144
Banner University Medical Center - Phoenix
Phoenix, Arizona, 85006
BNI
Phoenix, Arizona, 85260
Allegheny General
Pittsburgh, Pennsylvania, 15212
Texas Stroke Institute
Plano, Texas, 75075
Westside Regional Medical Center
Plantation, Florida, 33324
University of Rochester Medical Center
Rochester, New York, 14642
Mercy San Juan
Sacramento, California, 95608
Cottage Hospital
Santa Barbara, California, 93105
Clinical Radiologist
Springfield, Illinois, 62704
Bayfront Medical Center
St. Petersburg, Florida, 33701
Stony Brook University
Stony Brook, New York, 11794
Overlook Medical Center
Summit, New Jersey, 07901
Tacoma General
Tacoma, Washington, 98405
University of South Florida
Tampa, Florida, 33620
St. Vincent
Toledo, Ohio, 43608
Banner - University Medical Center Tucson
Tucson, Arizona, 85724
St. Mary's Hospital
West Palm Beach, Florida, 33407
RIA - Lutheran Medical Center
Wheat Ridge, Colorado, 80112
Valley Health Winchester
Winchester, Virginia, 22601
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Metro Health Hospital
Wyoming, Michigan, 49519
About this study
Official title: SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System
The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.
Read the detailed description
This is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart System (Smart), Penumbra Coil 400TM (PC 400), and Penumbra Occlusion Device (POD®). Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up. Approximately 1,000 patients with intracranial aneurysms or other malformations treated by the Smart System at up to 100 centers will be enrolled. It is anticipated patient enrollment will take 3 years. All patients are to be assessed in accordance with the standard of care at each participating hospital through one year follow-up.
- Conditions
- Intracranial Aneurysm
- Being tested
- Penumbra Smart Coil, Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
- Keywords
- Penumbra Smart coils, PC 400, AV malformations, AV fistulae, POD
- Medical subject headings
- Intracranial Aneurysm, Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penumbra Smart CoilDevice
Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)Device
Other Penumbra Coils available as standard of care
| Study group | Role | What they receive |
|---|---|---|
| Penumbra Smart System | Other | Not described Receives: Device: Penumbra Smart Coil; Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Adequate Occlusion Immediate Post Procedure
Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.
Measured: Immediate Post Procedure
Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout
Re-access attempts due to catheter kick-out across all coils
Measured: Immediate Post Procedure
Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure
Measured: Immediate Post Procedure
Number of Participants Requiring Retreatment Through Follow-up
Measured: One year from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start3 Jun 2016
- Primary completion27 Dec 2019
- Study completion27 Dec 2019
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 (3)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 995 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729740
- Sponsor's protocol ID
- CLP 10023
- Acronym
- SMART
- Status last verified
- Feb 2021
- First submitted
- 15 Mar 2016
- Last updated
- 1 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ashouri Y, Paul AR, AlMajali M, Chaudhari A, Lin E, Park MS, Bellon RJ, Bohnstedt BN, Yoo AJ, Schirmer CM, DeLeacy RA, Fiorella DJ, Woodward K, Hawk HE, Nanda A, Sunenshine PJ, Kabbani MR, Snyder KV, Sivapatham T, Dumont TM, Reeves AR, Starke RM, Spiotta AM, Zaidat OO. Large and giant intracranial aneurysms: outcomes from the multicenter prospective SMART coils registry. Front Neurol. 2026 Jan 14;16:1670622. doi: 10.3389/fneur.2025.1670622. eCollection 2025.
PubMed 41613189Spiotta AM, Park MS, Bellon RJ, Bohnstedt BN, Yoo AJ, Schirmer CM, DeLeacy RA, Fiorella DJ, Woodward BK, Hawk HE, Nanda A, Zaidat OO, Sunenshine PJ, Liu KC, Kabbani MR, Snyder KV, Sivapatham T, Dumont TM, Reeves AR, Starke RM; SMART Registry Investigators. The SMART Registry: Long-Term Results on the Utility of the Penumbra SMART COIL System for Treatment of Intracranial Aneurysms and Other Malformations. Front Neurol. 2021 Apr 13;12:637551. doi: 10.3389/fneur.2021.637551. eCollection 2021.
PubMed 33927680Starke RM, Park MS, Bellon R, Bohnstedt B, Schirmer CM, De Leacy R, Fiorella D, Yoo AJ, Spiotta AM; SMART Registry Investigators. Periprocedural safety of saccular aneurysm embolization with the Penumbra SMART Coil System: a SMART registry subset analysis. J Neurointerv Surg. 2022 Jan;14(1):neurintsurg-2020-016943. doi: 10.1136/neurintsurg-2020-016943. Epub 2021 Feb 16.
PubMed 33593799
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System
- ClinicalTrials.gov ID
- NCT02729740
- Acronym / sponsor ID
- SMART / CLP 10023
- Conditions
- Intracranial Aneurysm
- Keywords
- Penumbra Smart coils, PC 400, AV malformations, AV fistulae, POD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 995 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2016 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Posted 1 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.
Detailed description
This is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart System (Smart), Penumbra Coil 400TM (PC 400), and Penumbra Occlusion Device (POD®). Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up. Approximately 1,000 patients with intracranial aneurysms or other malformations treated by the Smart System at up to 100 centers will be enrolled. It is anticipated patient enrollment will take 3 years. All patients are to be assessed in accordance with the standard of care at each participating hospital through one year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penumbra Smart System | Other | Device: Penumbra Smart Coil, Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients enrolled in this study must sign the Informed Consent Form and be treated according to the cleared indications for the Smart, PC 400, and POD, which include the embolization of:
- Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
Key exclusion criteria (3 listed)
- Life expectancy less than one year
- Smart, PC 400, or POD account for less than 75% of total number of coils implanted
- Participation in another clinical investigation that could confound the evaluation of the registry device
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 |
|---|---|---|
| Penumbra Smart Coil | Device | Penumbra Smart System |
| Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)Other Penumbra Coils available as standard of care | Device | Penumbra Smart System |
Primary outcome
Number of Participants Achieving Adequate Occlusion Immediate Post Procedure
Time frame: Immediate Post Procedure
Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.
Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout
Time frame: Immediate Post Procedure
Re-access attempts due to catheter kick-out across all coils
Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure
Time frame: Immediate Post Procedure
Number of Participants Requiring Retreatment Through Follow-up
Time frame: One year from enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41613189Ashouri Y, Paul AR, AlMajali M, Chaudhari A, Lin E, Park MS, Bellon RJ, Bohnstedt BN, Yoo AJ, Schirmer CM, DeLeacy RA, Fiorella DJ, Woodward K, Hawk HE, Nanda A, Sunenshine PJ, Kabbani MR, Snyder KV, Sivapatham T, Dumont TM, Reeves AR, Starke RM, Spiotta AM, Zaidat OO. Large and giant intracranial aneurysms: outcomes from the multicenter prospective SMART coils registry. Front Neurol. 2026 Jan 14;16:1670622. doi: 10.3389/fneur.2025.1670622. eCollection 2025.
- Derived from this study: PubMed 33927680Spiotta AM, Park MS, Bellon RJ, Bohnstedt BN, Yoo AJ, Schirmer CM, DeLeacy RA, Fiorella DJ, Woodward BK, Hawk HE, Nanda A, Zaidat OO, Sunenshine PJ, Liu KC, Kabbani MR, Snyder KV, Sivapatham T, Dumont TM, Reeves AR, Starke RM; SMART Registry Investigators. The SMART Registry: Long-Term Results on the Utility of the Penumbra SMART COIL System for Treatment of Intracranial Aneurysms and Other Malformations. Front Neurol. 2021 Apr 13;12:637551. doi: 10.3389/fneur.2021.637551. eCollection 2021.
- Derived from this study: PubMed 33593799Starke RM, Park MS, Bellon R, Bohnstedt B, Schirmer CM, De Leacy R, Fiorella D, Yoo AJ, Spiotta AM; SMART Registry Investigators. Periprocedural safety of saccular aneurysm embolization with the Penumbra SMART Coil System: a SMART registry subset analysis. J Neurointerv Surg. 2022 Jan;14(1):neurintsurg-2020-016943. doi: 10.1136/neurintsurg-2020-016943. Epub 2021 Feb 16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
72 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penumbra Smart Coil and Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD) in people with Intracranial Aneurysm, run by Penumbra Inc. at 72 sites in 2 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 3 inclusion and 3 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 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Canada. 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 1 Mar 2021). 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?
Number of Participants Achieving Adequate Occlusion Immediate Post Procedure (time frame: Immediate Post Procedure). The study lists 4 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 NCT02729740, which also lists 3 linked publications.
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 1 Mar 2021.