International Registry of Flow Diverter Stents

Intracranial Aneurysm Clinical Trial

— IRF  

Official title:

Outcomes of Flow Diverters for Treatment of Intracranial Aneurysms - International Registry of Flow Diverter Stents (IRF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174727
• Other study ID #: 2023-15177
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Montefiore Medical Center
• Contact: Muhammed Amir Essibayi, MD
• Phone: 347-908-1889
• Email: Muhammedamir.essibayi[@]einsteinmed.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This multi-center retrospective cohort study aims to investigate the technical and clinical outcomes of intracranial aneurysms treated with Flow diverter stents.

Description:

Flow diverters utilized for the treatment of intracranial aneurysms have outcomes such as shorter procedure times, less radiation exposure, less need for adjunct devices, and better angiographic outcomes. 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. Prior studies have demonstrated promising safety and efficacy profile; however, the available data for a direct comparison of the technical and clinical outcomes between these devices remains limited. This retrospective cohort study aims to investigate the technical and clinical outcomes of intracranial aneurysms treated with approved Flow diverter stents.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (18 years of age or older)
• Prior completion of Endovascular intracranial flow diverter stent procedure using any of the following devices: Pipeline Flex (Covidien, California, USA), Pipeline Flex with Shield Technology (Covidien), Surpass Streamline (Stryker Neurovascular, California, USA), Surpass Evolve (Stryker), Silk flow diverter (SILK; Balt Extrusion, Montmorency, France), Flow-Redirection Intraluminal Device (FRED; MicroVention), Flow-Redirection Intraluminal Device X (FRED X; MicroVention), p64 Flow Modulation Device.

Exclusion Criteria:

• Intracranial flow diversion procedure using a device not identified within the Inclusion Criteria

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Locations

Country	Name	City	State
United States	Montefiore Medical Center Department of Neurosurgery	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Complications following placement of Flow Diverter Stents	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 stent placement.	From the time of the procedure up to 1 month post treatment
Primary	Clinical Outcomes on 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.	Upon study discharge, up to 4 weeks
Primary	Immediate Angiographic Outcomes on Discharge	The O'Kelly-Marotta (OKM) grading 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.	Upon study discharge, up to 4 weeks
Primary	Clinical Outcomes at Follow-up	Clinical outcomes at 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.	Up to 24 months post procedure
Primary	Angiographic Outcomes at Follow-up	The O'Kelly-Marotta (OKM) grading 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.	Up to 24 months post procedure
Primary	Recurrence of Aneurysm	The percentage of patients who experienced a recurrence of aneurysm will be recorded	6 to 24 months post procedure