Brain AneurysmSCENTNCT01716117
Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms
A study testing Surpass Flow Diverter in people with Brain Aneurysm, run by Stryker Neurovascular at 26 sites in 2 countries.
Trial summary
This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide-neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Brain Aneurysm
- What is being tested?
- Surpass Flow Diverter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 25 Oct 2012to 7 Jul 2022
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 to 80 years
- Subject or legal representative is willing and able to give informed consent
- Subject has a single targeted intracranial aneurysm
- Subject agrees to return to the treating Investigator for all scheduled follow up visits and is capable of returning to the hospital for follow up
Who cannot join
- Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or general anesthesia
- Known history of life threatening allergy to contrast dye
- Known allergy to nickel, chromium cobalt, tungsten or platinum
- Subject has documented resistance to clopidogrel/Plavix
- Major surgery within previous 30 days or planned in the next 120 days after enrollment date
- Previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date
Show all 32Show fewer
- Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date
- Any previous stenting of parent artery at or proximal to the aneurysm where it would interfere with the placement and proper apposition of the device
- Any previous coiling where it would interfere with the placement and proper apposition of the device
- Platelet count less than 100,000 cells/mm3 or known platelet dysfunction
- More than one intracranial aneurysm (IA) that requires treatment within 12 months
- Asymptomatic extradural aneurysms requiring treatment
- Contraindication to CT scan or MRI
- Severe neurological deficit that renders the subject incapable of living independently
- Unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days)
- Evidence of active infection at the time of treatment
- Dementia or psychiatric problem that prevents the patient from completing required follow up
- Co-morbid conditions that may limit survival to less than 24 months
- Serum creatinine greater or equal to 2.5 mg/dL
- Female subjects who are pregnant or planning to become pregnant within the study period
- Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis
- Extra-cranial stenosis or parent vessel with stenosis greater than 50% in the area proximal to the aneurysm
- Other known serious concurrent medical conditions
- History of intracranial vasospasm not responsive to medical therapy
- Subject with an intracranial mass, or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
- Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions
- Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date
- Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
- Inability to understand the study or a history of non-compliance with medical advice
- Current use of illicit substance
- Enrollment in another trial involving an investigational product
- Subject has a need for long-term use of anticoagulants (i.e., Warfarin, Dabigatran)
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States25 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University at Buffalo
Buffalo, New York, 14203
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas - Southwestern
Dallas, Texas, 75390
University of Florida
Gainesville, Florida, 32611
Baylor College of Medicine
Houston, Texas, 77030
University of California
Irvine, California, 92697
Lyerly Neurosurgery/Baptist Health System
Jacksonville, Florida, 32207
Mayo Clinic - Florida
Jacksonville, Florida, 32224
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Fort Sanders Medical Center
Knoxville, Tennessee, 37916
Baptist Hospital of Miami
Miami, Florida, 33176
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Columbia University
New York, New York, 10032
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic - Minnesota
Rochester, Minnesota, 55902
University of Utah
Salt Lake City, Utah, 84132
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Tampa General Hospital
Tampa, Florida, 33606
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT Trial)
This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide-neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left untreated, the bulge may continue to grow larger and ultimately the vessel may break open (rupture), resulting in serious bleeding into or around the brain. The information collected from this study will be used to evaluate how well patients do when treated with the Surpass System both immediately after treatment of an aneurysm and over a long period of time (5 years).
Read the detailed description
The objective of this study is to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus. The Surpass Flow Diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm. Use of the Surpass System may be associated with a decrease in neurological death or ipsilateral stroke in patients with large or giant wide-neck aneurysms. In a given patient, the Surpass System will be deemed effective if treatment results in complete occlusion of their aneurysm without clinically significant stenosis of the parent artery, or requires retreatment of the aneurysm through 12 months.
- Conditions
- Brain Aneurysm
- Being tested
- Surpass Flow Diverter
- Keywords
- Large aneurysm, Giant aneurysm, Wide neck aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surpass Flow DiverterDevice
Also called Flow diverter, Endovascular aneurysm treatment
Treatment of an intracranial aneurysm involves the placement of a specially designed metallic mesh tube in a vessel in the brain where an aneurysm is located. The device looks like a fishnet sock with both ends open. Each device is delivered through a small catheter (a long, flexible tube). The catheter containing the device is inserted and advanced into a vessel in the brain. The device is then placed in the brain vessel by releasing it from the catheter. Once the device is placed inside the brain vessel, it is intended to reinforce the area of the vessel that is weakened and bulging (the aneurysm), and to cause blood to flow down the vessel and away from the aneurysm while allowing blood in the aneurysm to clot. This procedure is called an endovascular aneurysm treatment because the device is delivered through the blood vessels.
| Study group | Role | What they receive |
|---|---|---|
| Surpass Flow Diverter | Experimental | The objective of this study is to determine the safety and effectiveness of the Surpass Flow Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus. Receives: Device: Surpass Flow Diverter |
What is being measured
The primary outcome is the main question the study is designed to answer.
mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit.
Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit.
Measured: 12 months
mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up.
Subjects experiencing neurologic death or major ipsilateral stroke through 12 months.
Measured: 12 months
Secondary outcomes (1)
Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure
The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete obliteration (best); Class II: residual neck; Class III: residual aneurysm (worse).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study start25 Oct 2012
- Primary completion11 Dec 2016
- Study completion7 Jul 2022
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 (6)Papers the sponsor has linked to this study.
- Other trials for Brain 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
- Model description
- The SCENT Trial is a multi-center, prospective, non-randomized trial.
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ricardo A Hanel, MD, PhD, Principal investigator, Lyerly Baptist Medical Center, Jacksonville, FloridaPhilip M Meyers, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716117
- Sponsor's protocol ID
- SP-04
- Acronym
- SCENT
- Status last verified
- Dec 2022
- First submitted
- 24 Oct 2012
- Last updated
- 19 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make IPD information available to other researchers. Blinded study data by mITT and Roll-in cohorts may be made available to SCENT researchers post publication of the primary study results.
Publications
Wakhloo AK, Jenkins P, Meyers PM, Coon AL, Kan PT, Puri AS, de Vries J, Lanzino G, Bain MD, Ebersole KC, Welch BG, Dogan A, Jabbour PM, Mocco J, Siddiqui AH, Turk AS, Taussky P, Hanel RA. Patient's Age Impact on Stroke Risk and Intracranial Aneurysm Occlusion: SCENT Flow Diverter Study-A Nonrandomized Clinical Trial on Large and Giant Aneurysms. Neurosurg Pract. 2026 Apr 17;7(2):e000222. doi: 10.1227/neuprac.0000000000000222. eCollection 2026 Jun.
PubMed 42007246Meyers PM, Coon AL, Kan P, Dogan A, Bain M, Welch BG, Ebersole K, De Vries J, Wakhloo AK, Taussky P, Jenkins P, Hanel RA; SCENT Investigators. Five-year results of the SCENT trial with Surpass flow diverters to treat large or giant wide-neck aneurysms. J Neurointerv Surg. 2025 Sep 12;17(10):1078-1082. doi: 10.1136/jnis-2024-022977.
PubMed 40335285Hanel RA, Cortez GM, Coon AL, Kan P, Taussky P, Wakhloo AK, Welch BG, Dogan A, Bain M, De Vries J, Ebersole K, Meyers PM; SCENT Investigator Group. Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms - SCENT: 3-year outcomes. J Neurointerv Surg. 2023 Nov;15(11):1084-1089. doi: 10.1136/jnis-2022-019512. Epub 2022 Nov 14.
PubMed 36375835Kan P, Mohanty A, Meyers PM, Coon AL, Wakhloo AK, Marosfoi M, Bain M, de Vries J, Ebersole K, Lanzino G, Taussky P, Hanel RA. Treatment of large and giant posterior communicating artery aneurysms with the Surpass streamline flow diverter: results from the SCENT trial. J Neurointerv Surg. 2023 Jul;15(7):679-683. doi: 10.1136/neurintsurg-2021-018189. Epub 2022 May 12.
PubMed 35551072Meyers PM, Coon AL, Kan PT, Wakhloo AK, Hanel RA. SCENT Trial. Stroke. 2019 Jun;50(6):1473-1479. doi: 10.1161/STROKEAHA.118.024135. Epub 2019 May 14.
PubMed 31084335Colby GP, Lin LM, Caplan JM, Jiang B, Michniewicz B, Huang J, Tamargo RJ, Coon AL. Flow diversion of large internal carotid artery aneurysms with the surpass device: impressions and technical nuance from the initial North American experience. J Neurointerv Surg. 2016 Mar;8(3):279-86. doi: 10.1136/neurintsurg-2015-011769. Epub 2015 May 18.
PubMed 25987590
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT Trial)
- ClinicalTrials.gov ID
- NCT01716117
- Acronym / sponsor ID
- SCENT / SP-04
- Conditions
- Brain Aneurysm
- Keywords
- Large aneurysm, Giant aneurysm, Wide neck aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2012 (actual)
- Primary completion
- 11 Dec 2016 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide-neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left untreated, the bulge may continue to grow larger and ultimately the vessel may break open (rupture), resulting in serious bleeding into or around the brain. The information collected from this study will be used to evaluate how well patients do when treated with the Surpass System both immediately after treatment of an aneurysm and over a long period of time (5 years).
Detailed description
The objective of this study is to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus. The Surpass Flow Diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm. Use of the Surpass System may be associated with a decrease in neurological death or ipsilateral stroke in patients with large or giant wide-neck aneurysms. In a given patient, the Surpass System will be deemed effective if treatment results in complete occlusion of their aneurysm without clinically significant stenosis of the parent artery, or requires retreatment of the aneurysm through 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The SCENT Trial is a multi-center, prospective, non-randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Surpass Flow Diverter | Experimental | Device: Surpass Flow DiverterThe objective of this study is to determine the safety and effectiveness of the Surpass Flow Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 19 to 80 years
- Subject or legal representative is willing and able to give informed consent
- Subject has a single targeted intracranial aneurysm
- Subject agrees to return to the treating Investigator for all scheduled follow up visits and is capable of returning to the hospital for follow up
Key exclusion criteria (32 listed)
- Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or general anesthesia
- Known history of life threatening allergy to contrast dye
- Known allergy to nickel, chromium cobalt, tungsten or platinum
- Subject has documented resistance to clopidogrel/Plavix
- Major surgery within previous 30 days or planned in the next 120 days after enrollment date
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 |
|---|---|---|
| Surpass Flow DiverterAlso: Flow diverter, Endovascular aneurysm treatmentTreatment of an intracranial aneurysm involves the placement of a specially designed metallic mesh tube in a vessel in the brain where an aneurysm is located. The device looks like a fishnet sock with both ends open. Each device is delivered through a small catheter (a long, flexible tube). The catheter containing the device is inserted and advanced into a vessel in the brain. The device is then placed in the brain vessel by releasing it from the catheter. Once the device is placed inside the brain vessel, it is intended to reinforce the area of the vessel that is weakened and bulging (the aneurysm), and to cause blood to flow down the vessel and away from the aneurysm while allowing blood in the aneurysm to clot. This procedure is called an endovascular aneurysm treatment because the device is delivered through the blood vessels. | Device | Surpass Flow Diverter |
Primary outcome
mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit.
Time frame: 12 months
Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit.
mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up.
Time frame: 12 months
Subjects experiencing neurologic death or major ipsilateral stroke through 12 months.
1 secondary outcome
Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42007246Wakhloo AK, Jenkins P, Meyers PM, Coon AL, Kan PT, Puri AS, de Vries J, Lanzino G, Bain MD, Ebersole KC, Welch BG, Dogan A, Jabbour PM, Mocco J, Siddiqui AH, Turk AS, Taussky P, Hanel RA. Patient's Age Impact on Stroke Risk and Intracranial Aneurysm Occlusion: SCENT Flow Diverter Study-A Nonrandomized Clinical Trial on Large and Giant Aneurysms. Neurosurg Pract. 2026 Apr 17;7(2):e000222. doi: 10.1227/neuprac.0000000000000222. eCollection 2026 Jun.
- Derived from this study: PubMed 40335285Meyers PM, Coon AL, Kan P, Dogan A, Bain M, Welch BG, Ebersole K, De Vries J, Wakhloo AK, Taussky P, Jenkins P, Hanel RA; SCENT Investigators. Five-year results of the SCENT trial with Surpass flow diverters to treat large or giant wide-neck aneurysms. J Neurointerv Surg. 2025 Sep 12;17(10):1078-1082. doi: 10.1136/jnis-2024-022977.
- Derived from this study: PubMed 36375835Hanel RA, Cortez GM, Coon AL, Kan P, Taussky P, Wakhloo AK, Welch BG, Dogan A, Bain M, De Vries J, Ebersole K, Meyers PM; SCENT Investigator Group. Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms - SCENT: 3-year outcomes. J Neurointerv Surg. 2023 Nov;15(11):1084-1089. doi: 10.1136/jnis-2022-019512. Epub 2022 Nov 14.
- Derived from this study: PubMed 35551072Kan P, Mohanty A, Meyers PM, Coon AL, Wakhloo AK, Marosfoi M, Bain M, de Vries J, Ebersole K, Lanzino G, Taussky P, Hanel RA. Treatment of large and giant posterior communicating artery aneurysms with the Surpass streamline flow diverter: results from the SCENT trial. J Neurointerv Surg. 2023 Jul;15(7):679-683. doi: 10.1136/neurintsurg-2021-018189. Epub 2022 May 12.
- Derived from this study: PubMed 31084335Meyers PM, Coon AL, Kan PT, Wakhloo AK, Hanel RA. SCENT Trial. Stroke. 2019 Jun;50(6):1473-1479. doi: 10.1161/STROKEAHA.118.024135. Epub 2019 May 14.
- Derived from this study: PubMed 25987590Colby GP, Lin LM, Caplan JM, Jiang B, Michniewicz B, Huang J, Tamargo RJ, Coon AL. Flow diversion of large internal carotid artery aneurysms with the surpass device: impressions and technical nuance from the initial North American experience. J Neurointerv Surg. 2016 Mar;8(3):279-86. doi: 10.1136/neurintsurg-2015-011769. Epub 2015 May 18.
- Individual participant dataSharing planned: No. There is no plan to make IPD information available to other researchers. Blinded study data by mITT and Roll-in cohorts may be made available to SCENT researchers post publication of the primary study results.
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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.
Ricardo A Hanel, MD, PhD principal investigator
Lyerly Baptist Medical Center, Jacksonville, Florida
Philip M Meyers, MD principal investigator
Columbia University
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surpass Flow Diverter in people with Brain Aneurysm, run by Stryker Neurovascular at 26 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 4 inclusion and 32 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 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Netherlands. 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 23 Jul 2019). 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?
mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit. (time frame: 12 months). The study lists 2 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 NCT01716117, which also lists 6 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 19 Dec 2022.