International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.