Flow Diverters for Brain Aneurysm
(IRF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness and safety of certain devices for treating brain aneurysms, which are bulging blood vessels in the brain that can be dangerous if they burst. The focus is on two main treatments: flow diverter stents and endosaccular flow disruptors, both designed to prevent aneurysms from growing or rupturing. The trial will compare the outcomes of these two methods. Individuals who have undergone one of these treatments and have complete medical records are well-suited for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
What prior data suggests that these devices are safe for treating brain aneurysms?
Research has shown that flow diverters are generally safe for treating brain aneurysms. One study found these devices effective and safe, particularly for aneurysms that have returned or weren't fully treated before. Approximately 17% of patients may experience some issues, but serious complications leading to death are rare, occurring in only about 2.8% of cases. Another study noted that while there might be more complications during the procedure itself, the long-term safety is similar to other treatments. Overall, flow diverters appear to be a well-tolerated option for many patients.12345
Why are researchers excited about this trial?
Researchers are excited about intra-arterial and endosaccular flow diverters because they offer a novel approach to treating brain aneurysms. Unlike traditional surgical methods like clipping or coiling, these devices work by redirecting blood flow away from the aneurysm, encouraging the vessel to heal naturally. This technique can potentially reduce the risk of rupture with a less invasive procedure and quicker recovery time. Additionally, flow diverters can be used for aneurysms that are difficult to treat with standard options, broadening the range of patients who can receive effective treatment.
What evidence suggests that flow diverters are effective for brain aneurysms?
Studies have shown that flow diverters effectively treat brain aneurysms. In approximately 72.7% to 96% of cases, the aneurysm was completely closed off, preventing harm. Research indicates that although some complications can arise from the procedure, flow diverters are generally safe. They often outperform other methods for treating aneurysms, making them a promising option for many patients.34567
Who Is on the Research Team?
David Altschul, MD
Principal Investigator
Montefiore Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure
Participants undergo the placement of flow diverter stents or endosaccular flow disruptors for the treatment of intracranial aneurysms
Immediate Post-Procedure
Immediate angiographic outcomes and technical success are assessed using various grading scales
Follow-up
Participants are monitored for clinical outcomes and angiographic success, including recurrence and retreatment of aneurysms
What Are the Treatments Tested in This Trial?
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor
Mayo Clinic
Collaborator
Simpson Memorial Research Institute
Collaborator
Geisinger Health
Collaborator
University at Buffalo
Collaborator
Thomas Jefferson University
Collaborator
Citations
Flow Diversion for Cerebral Aneurysms: A Decade-Long ...
Results: Complete aneurysm occlusion was achieved in 72.7% of cases, with a complication rate of 9.1%. Significant predictors of complete occlusion included ...
Long-term outcomes of flow diversion for unruptured ...
The pooled occlusion rates after flow diversion treatment for unruptured intracranial brain aneurysms were 77%, 87.4%, 84.5%, 89.4%, 96% for 1 ...
Evaluation of flow diverters for cerebral aneurysm therapy
A standardized methodology is proposed for evaluating and reporting radiological outcomes of FD treatment of intracranial aneurysms.
The Safety and Efficacy of Flow Diversion versus ...
The placement of a flow diverter may lead to more procedure-related complications, but there is no difference in safety, and it is more effective in the long ...
NCT01716117 | Safety and Effectiveness of an Intracranial ...
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 ...
Efficacy and safety of flow diverters in retreatment ...
Flow diverter stents are an effective and safe method for retreating recurrent or residual intracranial aneurysms with a high rate of complete and adequate ...
Complications associated with the use of flow-diverting ...
The use of FDDs was associated with an overall complication rate of 17.0% (95% confidence interval [CI] 13.6%–20.5%) and a low mortality rate of 2.8% (95% CI 1 ...
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