Intracranial AneurysmIRFNCT06174727
International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)
An observational study of Intracranial Aneurysm, run by Montefiore Medical Center at 13 sites in 2 countries.
Trial summary
This multicenter retrospective cohort study aims to evaluate and compare the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm
- How many people
- 5,000 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 1 Oct 2023to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 who underwent endovascular treatment with flow diverter stents or endosaccular flow disruptors
Who may be able to join
- Consecutive adult patients (18 years of age or older)
- Underwent endovascular treatment with one of the following devices:
- Endoluminal Flow Diverter Stents: i. Pipeline Flex (Covidien, California, USA) ii. Pipeline Flex with Shield Technology (Covidien) iii. Surpass Streamline (Stryker Neurovascular, California, USA) iv. Surpass Evolve (Stryker) v. Silk flow diverter (Balt Extrusion, Montmorency, France) vi. Flow-Redirection Intraluminal Device (FRED; MicroVention) vii. Flow-Redirection Intraluminal Device X (FRED X; MicroVention) viii. p64 Flow Modulation Device (phenox GmbH) ix. Endovascular clip system (eCLIPs) (eCLIPsTM, eVasc Neurovascular, Vancouver, BC, Canada)
- Intrasaccular Flow Disruptors: i. Woven EndoBridge (WEB; MicroVention) ii. Luna/Artisse System (Medtronic) iii. Medina Embolic Device (Medtronic) iv. Contour Neurovascular System (Cerus Endovascular) v. Neqstent Coil Assisted Flow Diverter (Cerus Endovascular) vi. pCONus and pCANvas (phenox GmbH) vii. Nexus Aneurysm Embolization System (EndoStream Medical) viii. CITADEL™ Embolization Device (Balt, USA)
- Complete medical records and follow-up data available
Who cannot join
- Incomplete procedural or follow-up records
- Non-flow-diverter or non-flow-disruptor treatments (e.g., coiling-only cases)
- Aneurysms treated with investigational devices not listed within Inclusion Criteria
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
United States11 sites, 6 recruiting
- Completed
University at Buffalo
Buffalo, New York, 14068
- Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Timo Krings, MD, PhD, MSc, 781-744-3330, Timo.Krings@lahey.org
Timo Krings, MD, PhD, MSc
- Recruiting
University of Miami
Coral Gables, Florida, 33146
Robert M Starke, MD, MS, 305-355-1101, RStarke@med.miami.edu
Robert M Starke, MD, MS
- Completed
Geisinger Health
Danville, Pennsylvania, 17822
- Completed
Mayo Clinic Florida
Jacksonville, Florida, 32224
- Completed
HCA Houston Healthcare Kingwood
Kingwood, Texas, 77339
- Recruiting
Allina Health
Minneapolis, Minnesota, 55404
Collin M Torok, MD, 612-863-0376, collin.torok@allina.com
Marie Meyer, MA, marie.meyer@allina.com
- Recruiting
Robert Wood Johnson University
New Brunswick, New Jersey, 08901
Gaurav Gupta, MD, 732-235-6333, guptaga@rwjms.rutgers.edu
Gaurav Gupta, MD
- Completed
Sarasota Memorial Research Institute
Sarasota, Florida, 34239
- Recruiting
Montefiore Medical Center Department of Neurosurgery
The Bronx, New York, 10467
Muhammed Amir Essibayi, MD, 347-908-1889, Muhammedamir.essibayi@einsteinmed.edu
David Altschul, MD, (718) 920-7498, daltschu@montefiore.org
- Recruiting
Munson Medical Center
Traverse City, Michigan, 49684
Amy Peterson, PhD, 231-935-6746, apeterson4@mhc.net
Canada2 sites, 2 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Vitor Mendes Pereira, MD, 416-864-5131, PereiraReferrals@unityhealth.to
Eileen Liu, MSc, eileen.liu@unityhealth.to
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Pascal Mosimann, MD, PD, 416-603 5800, pascal.mosimann@uhn.ca
Pascal Mosimann, MD, PD
About this study
Official title: Outcomes of Intra-arterial and Endosaccular Flow Diverters for Treatment of Intracranial Aneurysms - International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)
This multicenter retrospective cohort study aims to evaluate and compare the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors.
Read the detailed description
Flow diverters and endosaccular flow disruptors used for the treatment of intracranial aneurysms exhibit distinct procedural and clinical outcomes, with potential differences in device-specific parameters such as procedure time, radiation exposure, adjunct device requirements, and long-term angiographic success. Since the completion of the Pipeline Embolization Device (PED) for the Intracranial Treatment of Aneurysms trial, the field of flow diversion has undergone continuous evolution with the development and approval of several devices. While these devices share a similar mechanism for aneurysm occlusion, their design and delivery systems can vary significantly. Various studies have demonstrated a promising safety and efficacy profile; however, the available data for a direct comparison of the technical and clinical outcomes between these devices remains limited.
The following collaborator is also involved in the research:
Name: Muhammed Amir Essibayi Email: m.amir.essibayi@gmail.com
- Conditions
- Intracranial Aneurysm
- Keywords
- Endovascular, Registry, Flow Diverter Stents, Endosaccular Flow Disruptors, Flow Diversion
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endoluminal Flow Diverter Stent | Adults with intracranial aneurysms treated with an endoluminal flow diverter stent as part of routine care. | |
| Intrasaccular Flow Disruptor | Adults with intracranial aneurysms treated with an intrasaccular flow disruptor as part of routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Technical Success will be determined by successful deployment of the flow diverter stent or endosaccular flow disruptors. A dichotomous determination (i.e., Yes/No) will be made and summarized for this study.
Measured: Periprocedurally, up to 24 hours
Procedural Complications following placement
Procedural complications will be identified as the number of instances of the following adverse clinical events: In-stent Thrombosis/Stenosis; Ischemic complications (Transient Ischemic Attack/Stroke), Intracerebral hemorrhage, Aneurysm rupture, and Vessel occlusion due to flow diverter stent or endosaccular flow disruptor placement.
Measured: From the time of the procedure up to 1 month post treatment
Clinical Outcomes at Discharge
Clinical outcomes at discharge will be assessed using the modified Rankin Scale (mRS) for neurologic disability. The mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a "favorable" outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an "unfavorable" outcome.
Measured: Upon study discharge, up to 4 weeks
Clinical Outcomes at last available Follow-up
Clinical outcomes at last available follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a "favorable" outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an "unfavorable" outcome. Scoring will also include a 6 to identify patients who have expired.
Measured: Up to 24 months post procedure
Immediate Angiographic Outcomes at Discharge - O'Kelly-Marotta (OKM) grading scale
Immediate Angiographic Outcomes at Discharge will be evaluated using the OKM grading scale. The OKM scale will be used to assess the degree of angiographic filling and in the setting of intracranial aneurysms which were treated by endovascular flow diversion. It is used to predict aneurysm closure over time. Patient outcomes will be stratified based on the following scale scores: Grade A: Total filling (>95% of aneurysm remained); Grade B: Subtotal filling (5-95% of aneurysm remained); Grade C: Entry remnant (<5% aneurysm remained); and Grade D: No filling (0% aneurysm remained). As such, the less aneurysm remnant the more favorable the angiographic outcome. The number/percentage of cases of each OKM Grade will be summarized.
Measured: Upon study discharge, up to 4 weeks
Immediate Angiographic Outcomes at Discharge - Modified Raymond-Roy Classification (mRRC)
Immediate Angiographic Outcomes at Discharge will also be evaluated using mRRC categorization. mRRC categorization will be used to assess the degree of occlusion achieved when treating an intracranial aneurysm. It categorizes the level of residual contrast filling within an aneurysm after coiling. For purposes of this analysis, Class I will signify complete occlusion; Class II will signify Residual neck occlusion; Class IIIa will signify Residual aneurysm with contrast stasis; and Class IIIb will signify Residual aneurysm without contrast stasis. As such, it is an indicator of how effectively the aneurysm has been sealed off during treatment. The number/percentage of cases of each mRRC category will be summarized.
Measured: Upon study discharge, up to 4 weeks
Immediate Angiographic Outcomes at Discharge - WEB Occlusion Scale (WOS)
Immediate Angiographic Outcomes at Discharge will be evaluated using the WOS grading scale. The WOS is a standardized angiographic assessment scale for reporting aneurysm occlusion achieved with endosaccular flow disruptors and can be employed to assess the adequacy of treatment. For purposes of this analysis, WOS Grade A will signify complete occlusion; WOS Grade B will signify Residual neck occlusion; and WOS Grade C will signify Residual aneurysm filling. The number/percentage of cases of each WOS grade category will be summarized.
Measured: Upon study discharge, up to 4 weeks
Angiographic Outcomes at last available Follow-up - O'Kelly-Marotta (OKM) grading scale
Immediate Angiographic Outcomes at Discharge will be evaluated using the OKM grading scale. The OKM scale will be used to assess the degree of angiographic filling and in the setting of intracranial aneurysms which were treated by endovascular flow diversion. It is used to predict aneurysm closure over time. Patient outcomes will be stratified based on the following scale scores: Grade A: Total filling (>95% of aneurysm remained); Grade B: Subtotal filling (5-95% of aneurysm remained); Grade C: Entry remnant (<5% aneurysm remained); and Grade D: No filling (0% aneurysm remained). As such, the less aneurysm remnant the more favorable the angiographic outcome. The number/percentage of cases of each OKM Grade will be summarized.
Measured: Up to 24 months post procedure
Angiographic Outcomes at last available Follow-up - Modified Raymond-Roy Classification (mRRC)
Immediate Angiographic Outcomes at Discharge will also be evaluated using mRRC categorization. mRRC categorization will be used to assess the degree of occlusion achieved when treating an intracranial aneurysm. It categorizes the level of residual contrast filling within an aneurysm after coiling. For purposes of this analysis, Class I will signify complete occlusion; Class II will signify Residual neck occlusion; Class IIIa will signify Residual aneurysm with contrast stasis; and Class IIIb will signify Residual aneurysm without contrast stasis. As such, it is an indicator of how effectively the aneurysm has been sealed off during treatment. The number/percentage of cases of each mRRC category will be summarized.
Measured: Up to 24 months post procedure
Angiographic Outcomes at last available Follow-up - WEB Occlusion Scale (WOS)
Immediate Angiographic Outcomes at Discharge will be evaluated using the WOS grading scale. The WOS is a standardized angiographic assessment scale for reporting aneurysm occlusion achieved with endosaccular flow disruptors and can be employed to assess the adequacy of treatment. For purposes of this analysis, WOS Grade A will signify complete occlusion; WOS Grade B will signify Residual neck occlusion; and WOS Grade C will signify Residual aneurysm filling. The number/percentage of cases of each WOS grade category will be summarized.
Measured: Up to 24 months post procedure
Secondary outcomes (5)
Radiation Exposure
Radiation exposure over the course of the procedure will be extracted and summarized. Radiation exposure will be evaluated based on relevant imaging system metrics used to calculate the total radiation dose delivered to the patient based on the fluoroscopy time and the area of the X-ray field exposed during the procedure. Flow diverter stents and endosaccular flow disruptors typically result in significantly lower radiation exposure compared to other endovascular techniques for treating brain aneurysms due to a reduction in fluoroscopy time and overall reduced radiation dose due to the streamlined nature of the procedures.
Measured: Periprocedurally, up to 4 hours
Procedure Duration
The duration of procedure placement will be extracted and summarized. The duration of the procedure is influenced by the complexity of the aneurysm, the patient's anatomy, and the experience of the interventional radiologist and care team. Shorter procedure duration times are associated with more favorable outcomes.
Measured: Periprocedurally, up to 4 hours
Use of Adjunct Devices
The use of adjunctive devices such as coils, stents or balloons to further enhance aneurysm occlusion of the flow diverter stent or to facilitate positioning and deployment of the endosaccular flow disruptor within the aneurysm sac during the procedure will be extracted and summarized. The number of adjunct devices will be extracted and summarized.
Measured: Periprocedurally, up to 4 hours
Recurrence of Aneurysm
The percentage of patients who experienced aneurysm recurrence will be extracted and summarized based on a binary (Yes/No) determination following retrospective record review. The span of time from initial treatment to recurrence will be assessed and summarized.
Measured: 6 to 24 months post procedure
Aneurysm Retreatment
The percentage of patients who required retreatment for a recurrence of aneurysm will be extracted and summarized based on a binary (Yes/No) determination following retrospective record review. The span of time from initial treatment to retreatment will be assessed and summarized.
Measured: 6 to 24 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Oct 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Sarasota Memorial Health Care System, Geisinger Health, University at Buffalo, Thomas Jefferson University, University Health Network, Toronto, Munson Medical Center, HCA Houston Healthcare Kingwood, University of Miami, Robert Wood Johnson University Hospital, Lahey Hospital & Medical Center, Unity Health Toronto, Allina Health System
- Responsible party
- Sponsor
- Investigators
- David Altschul, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174727
- Sponsor's protocol ID
- 2023-15177
- Other IDs
- 2023
- Acronym
- IRF
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nelson PK, Lylyk P, Szikora I, Wetzel SG, Wanke I, Fiorella D. The pipeline embolization device for the intracranial treatment of aneurysms trial. AJNR Am J Neuroradiol. 2011 Jan;32(1):34-40. doi: 10.3174/ajnr.A2421. Epub 2010 Dec 9.
PubMed 21148256Hecker C, Broussalis E, Griessenauer CJ, Killer-Oberpfalzer M. A mini-review of intrasaccular flow diverters. J Neurointerv Surg. 2023 Jan;15(1):70-74. doi: 10.1136/neurintsurg-2021-018426. Epub 2022 May 17.
PubMed 35580985Colby 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 25987590Vivanco-Suarez J, Feigen C, Javed K, Dardick JM, Holland R, Mendez-Ruiz A, Ortega-Gutierrez S, Haranhalli N, Altschul DJ. Dataset on flow diversion procedures performed with the Pipeline Embolization Device, Pipeline Flex, and Surpass Streamline for intracranial aneurysms. Data Brief. 2022 May 21;42:108299. doi: 10.1016/j.dib.2022.108299. eCollection 2022 Jun.
PubMed 35669008Wakhloo AK, Lylyk P, de Vries J, Taschner C, Lundquist J, Biondi A, Hartmann M, Szikora I, Pierot L, Sakai N, Imamura H, Sourour N, Rennie I, Skalej M, Beuing O, Bonafe A, Mery F, Turjman F, Brouwer P, Boccardi E, Valvassori L, Derakhshani S, Litzenberg MW, Gounis MJ; Surpass Study Group. Surpass flow diverter in the treatment of intracranial aneurysms: a prospective multicenter study. AJNR Am J Neuroradiol. 2015 Jan;36(1):98-107. doi: 10.3174/ajnr.A4078. Epub 2014 Aug 14.
PubMed 25125666O'kelly CJ, Krings T, Fiorella D, Marotta TR. A novel grading scale for the angiographic assessment of intracranial aneurysms treated using flow diverting stents. Interv Neuroradiol. 2010 Jun;16(2):133-7. doi: 10.1177/159101991001600204. Epub 2010 Jul 19.
PubMed 20642887
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Intra-arterial and Endosaccular Flow Diverters for Treatment of Intracranial Aneurysms - International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)
- ClinicalTrials.gov ID
- NCT06174727
- Acronym / sponsor ID
- IRF / 2023-15177
- Conditions
- Intracranial Aneurysm
- Keywords
- Endovascular, Registry, Flow Diverter Stents, Endosaccular Flow Disruptors, Flow Diversion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Mayo Clinic, Sarasota Memorial Health Care System, Geisinger Health, University at Buffalo, Thomas Jefferson University, University Health Network, Toronto, Munson Medical Center, HCA Houston Healthcare Kingwood, University of Miami, Robert Wood Johnson University Hospital, Lahey Hospital & Medical Center, Unity Health Toronto, Allina Health System
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter retrospective cohort study aims to evaluate and compare the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors.
Detailed description
Flow diverters and endosaccular flow disruptors used for the treatment of intracranial aneurysms exhibit distinct procedural and clinical outcomes, with potential differences in device-specific parameters such as procedure time, radiation exposure, adjunct device requirements, and long-term angiographic success. Since the completion of the Pipeline Embolization Device (PED) for the Intracranial Treatment of Aneurysms trial, the field of flow diversion has undergone continuous evolution with the development and approval of several devices. While these devices share a similar mechanism for aneurysm occlusion, their design and delivery systems can vary significantly. Various studies have demonstrated a promising safety and efficacy profile; however, the available data for a direct comparison of the technical and clinical outcomes between these devices remains limited.
The following collaborator is also involved in the research:
Name: Muhammed Amir Essibayi Email: m.amir.essibayi@gmail.com
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoluminal Flow Diverter Stent | – | –Adults with intracranial aneurysms treated with an endoluminal flow diverter stent as part of routine care. |
| Intrasaccular Flow Disruptor | – | –Adults with intracranial aneurysms treated with an intrasaccular flow disruptor as part of routine care. |
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 who underwent endovascular treatment with flow diverter stents or endosaccular flow disruptors
Key inclusion criteria (5 listed)
- Consecutive adult patients (18 years of age or older)
- Underwent endovascular treatment with one of the following devices:
- Complete medical records and follow-up data available
Key exclusion criteria (3 listed)
- Incomplete procedural or follow-up records
- Non-flow-diverter or non-flow-disruptor treatments (e.g., coiling-only cases)
- Aneurysms treated with investigational devices not listed within Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical Success
Time frame: Periprocedurally, up to 24 hours
Technical Success will be determined by successful deployment of the flow diverter stent or endosaccular flow disruptors. A dichotomous determination (i.e., Yes/No) will be made and summarized for this study.
Procedural Complications following placement
Time frame: From the time of the procedure up to 1 month post treatment
Procedural complications will be identified as the number of instances of the following adverse clinical events: In-stent Thrombosis/Stenosis; Ischemic complications (Transient Ischemic Attack/Stroke), Intracerebral hemorrhage, Aneurysm rupture, and Vessel occlusion due to flow diverter stent or endosaccular flow disruptor placement.
Clinical Outcomes at Discharge
Time frame: Upon study discharge, up to 4 weeks
Clinical outcomes at discharge will be assessed using the modified Rankin Scale (mRS) for neurologic disability. The mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a "favorable" outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an "unfavorable" outcome.
Clinical Outcomes at last available Follow-up
Time frame: Up to 24 months post procedure
Clinical outcomes at last available follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a "favorable" outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an "unfavorable" outcome. Scoring will also include a 6 to identify patients who have expired.
Immediate Angiographic Outcomes at Discharge - O'Kelly-Marotta (OKM) grading scale
Time frame: Upon study discharge, up to 4 weeks
Immediate Angiographic Outcomes at Discharge will be evaluated using the OKM grading scale. The OKM scale will be used to assess the degree of angiographic filling and in the setting of intracranial aneurysms which were treated by endovascular flow diversion. It is used to predict aneurysm closure over time. Patient outcomes will be stratified based on the following scale scores: Grade A: Total filling (>95% of aneurysm remained); Grade B: Subtotal filling (5-95% of aneurysm remained); Grade C: Entry remnant (<5% aneurysm remained); and Grade D: No filling (0% aneurysm remained). As such, the less aneurysm remnant the more favorable the angiographic outcome. The number/percentage of cases of each OKM Grade will be summarized.
Immediate Angiographic Outcomes at Discharge - Modified Raymond-Roy Classification (mRRC)
Time frame: Upon study discharge, up to 4 weeks
Immediate Angiographic Outcomes at Discharge will also be evaluated using mRRC categorization. mRRC categorization will be used to assess the degree of occlusion achieved when treating an intracranial aneurysm. It categorizes the level of residual contrast filling within an aneurysm after coiling. For purposes of this analysis, Class I will signify complete occlusion; Class II will signify Residual neck occlusion; Class IIIa will signify Residual aneurysm with contrast stasis; and Class IIIb will signify Residual aneurysm without contrast stasis. As such, it is an indicator of how effectively the aneurysm has been sealed off during treatment. The number/percentage of cases of each mRRC category will be summarized.
Immediate Angiographic Outcomes at Discharge - WEB Occlusion Scale (WOS)
Time frame: Upon study discharge, up to 4 weeks
Immediate Angiographic Outcomes at Discharge will be evaluated using the WOS grading scale. The WOS is a standardized angiographic assessment scale for reporting aneurysm occlusion achieved with endosaccular flow disruptors and can be employed to assess the adequacy of treatment. For purposes of this analysis, WOS Grade A will signify complete occlusion; WOS Grade B will signify Residual neck occlusion; and WOS Grade C will signify Residual aneurysm filling. The number/percentage of cases of each WOS grade category will be summarized.
Angiographic Outcomes at last available Follow-up - O'Kelly-Marotta (OKM) grading scale
Time frame: Up to 24 months post procedure
Immediate Angiographic Outcomes at Discharge will be evaluated using the OKM grading scale. The OKM scale will be used to assess the degree of angiographic filling and in the setting of intracranial aneurysms which were treated by endovascular flow diversion. It is used to predict aneurysm closure over time. Patient outcomes will be stratified based on the following scale scores: Grade A: Total filling (>95% of aneurysm remained); Grade B: Subtotal filling (5-95% of aneurysm remained); Grade C: Entry remnant (<5% aneurysm remained); and Grade D: No filling (0% aneurysm remained). As such, the less aneurysm remnant the more favorable the angiographic outcome. The number/percentage of cases of each OKM Grade will be summarized.
Angiographic Outcomes at last available Follow-up - Modified Raymond-Roy Classification (mRRC)
Time frame: Up to 24 months post procedure
Immediate Angiographic Outcomes at Discharge will also be evaluated using mRRC categorization. mRRC categorization will be used to assess the degree of occlusion achieved when treating an intracranial aneurysm. It categorizes the level of residual contrast filling within an aneurysm after coiling. For purposes of this analysis, Class I will signify complete occlusion; Class II will signify Residual neck occlusion; Class IIIa will signify Residual aneurysm with contrast stasis; and Class IIIb will signify Residual aneurysm without contrast stasis. As such, it is an indicator of how effectively the aneurysm has been sealed off during treatment. The number/percentage of cases of each mRRC category will be summarized.
Angiographic Outcomes at last available Follow-up - WEB Occlusion Scale (WOS)
Time frame: Up to 24 months post procedure
Immediate Angiographic Outcomes at Discharge will be evaluated using the WOS grading scale. The WOS is a standardized angiographic assessment scale for reporting aneurysm occlusion achieved with endosaccular flow disruptors and can be employed to assess the adequacy of treatment. For purposes of this analysis, WOS Grade A will signify complete occlusion; WOS Grade B will signify Residual neck occlusion; and WOS Grade C will signify Residual aneurysm filling. The number/percentage of cases of each WOS grade category will be summarized.
5 secondary outcomes
Radiation Exposure
Time frame: Periprocedurally, up to 4 hours
Procedure Duration
Time frame: Periprocedurally, up to 4 hours
Use of Adjunct Devices
Time frame: Periprocedurally, up to 4 hours
Recurrence of Aneurysm
Time frame: 6 to 24 months post procedure
Aneurysm Retreatment
Time frame: 6 to 24 months post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 21148256Nelson PK, Lylyk P, Szikora I, Wetzel SG, Wanke I, Fiorella D. The pipeline embolization device for the intracranial treatment of aneurysms trial. AJNR Am J Neuroradiol. 2011 Jan;32(1):34-40. doi: 10.3174/ajnr.A2421. Epub 2010 Dec 9.
- Background: PubMed 35580985Hecker C, Broussalis E, Griessenauer CJ, Killer-Oberpfalzer M. A mini-review of intrasaccular flow diverters. J Neurointerv Surg. 2023 Jan;15(1):70-74. doi: 10.1136/neurintsurg-2021-018426. Epub 2022 May 17.
- Background: 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.
- Background: PubMed 35669008Vivanco-Suarez J, Feigen C, Javed K, Dardick JM, Holland R, Mendez-Ruiz A, Ortega-Gutierrez S, Haranhalli N, Altschul DJ. Dataset on flow diversion procedures performed with the Pipeline Embolization Device, Pipeline Flex, and Surpass Streamline for intracranial aneurysms. Data Brief. 2022 May 21;42:108299. doi: 10.1016/j.dib.2022.108299. eCollection 2022 Jun.
- Background: PubMed 25125666Wakhloo AK, Lylyk P, de Vries J, Taschner C, Lundquist J, Biondi A, Hartmann M, Szikora I, Pierot L, Sakai N, Imamura H, Sourour N, Rennie I, Skalej M, Beuing O, Bonafe A, Mery F, Turjman F, Brouwer P, Boccardi E, Valvassori L, Derakhshani S, Litzenberg MW, Gounis MJ; Surpass Study Group. Surpass flow diverter in the treatment of intracranial aneurysms: a prospective multicenter study. AJNR Am J Neuroradiol. 2015 Jan;36(1):98-107. doi: 10.3174/ajnr.A4078. Epub 2014 Aug 14.
- Background: PubMed 20642887O'kelly CJ, Krings T, Fiorella D, Marotta TR. A novel grading scale for the angiographic assessment of intracranial aneurysms treated using flow diverting stents. Interv Neuroradiol. 2010 Jun;16(2):133-7. doi: 10.1177/159101991001600204. Epub 2010 Jul 19.
- 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.
David Altschul, MD principal investigator
Montefiore Medical Center
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Montefiore Medical Center at 13 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 5 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Amir Essibayi, MD (347-908-1889, Muhammedamir.essibayi@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: Periprocedurally, up to 24 hours). The study lists 10 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 NCT06174727, 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 21 Sep 2026.