An observational study in Intracranial Aneurysm, sponsored by Montefiore Medical Center. Recruiting at 13 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Montefiore Medical Center · Observational
Among 113 studies in Intracranial Aneurysm with a site in United States — 19 open to participants now, 33 under way, 1 of them phase 3. Intracranial Aneurysm · United States.
Among the 113 studies in Intracranial Aneurysm with a site in United States, this one is the 7th largest by planned enrollment of the 40 observational ones that give a count, is one of 7 that started in 2023, is one of 40 observational ones, reaches primary completion later than 14 of the 32 other live ones, and was the 100th registered.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
Browse Intracranial Aneurysm studies →19 of the 113 studies in Intracranial Aneurysm with a site in United States are open now. Recruiting first, the newest first:
phenox Inc. · Sites in United States
Ages 18+
Balt USA · Sites in United States, Canada
Ages 22–80
Medtronic Neurovascular Clinical Affairs · Sites in United States
Ages 22+
Stryker Neurovascular · Sites in United States
Ages 18–80
Cerus Endovascular, Inc. · Sites in United States
Ages 18–75
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 82 Intracranial Aneurysm studies recruiting now, 49 (60%) set no upper age limit and 14 (17%) stop at 75 or younger; 15 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
113 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 10 · Phase 3 6 · Phase 4 9
First in 2001; this study’s year is marked. 7 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 5,000 is above the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.
Median enrollment 67 across the 73 interventional studies, 126 across the 40 observational. Of the 61 that completed or were terminated, 34 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
47 of 113 have an industry lead sponsor. The 10 most frequent:
Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Montefiore Medical Center has 3 studies filed under Intracranial Aneurysm — fewer than ten, so there is no comparison to draw.
9 of the studies in Intracranial Aneurysm with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06282939HCA Healthcare Research InstituteOptima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry | 2026-12-01 |
| NCT06411418Jacobs instituteEvaluation of Flow Diverter Technology Device for Intracranial Aneurysm | 2026-12-30 |
| NCT05071963Medtronic Neurovascular Clinical AffairsINSPIRE Pipeline™ Shield Post Approval Study | 2027-01 |
| NCT05409989Microvention-Terumo, Inc.MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study | 2027-04 |
| NCT05636124Icahn School of Medicine at Mount SinaiKaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms | 2027-07 |
Among the 113 studies in Intracranial Aneurysm with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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
Patients with intracranial aneurysms who underwent endovascular treatment with flow diverter stents or endosaccular flow disruptors
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Underwent endovascular treatment with one of the following devices:
a. 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)
b. 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)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with intracranial aneurysms treated with an endoluminal flow diverter stent as part of routine care.
Adults with intracranial aneurysms treated with an intrasaccular flow disruptor as part of routine care.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months post procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 to 24 months post procedure
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Plan to share: No
Started Oct 2023 (actual). Primary completion is estimated for Jul 2027, 45 months after the start.
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