Clipping, Surveillance Imaging, or Endovascular Embolization for Brain Aneurysm

(POUIA Trial)

Recruiting at 1 trial location

Overseen By Genesis Liriano, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Intracranial hemorrhage, Severe psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how awareness of an unruptured brain aneurysm affects mental health, specifically anxiety and depression. It compares two groups: one receiving active treatment to secure the aneurysm and prevent rupture, and another undergoing regular monitoring without immediate intervention. Individuals aware of their unruptured brain aneurysm, whether opting for treatment or regular check-ups, may be suitable participants. The goal is to understand how awareness of their condition impacts mental well-being. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings on mental health impacts.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that microsurgical clipping and endovascular therapy are generally safe for treating unruptured brain aneurysms. One study reported no deaths from microsurgical clipping, with only 1.2% of patients experiencing serious complications, indicating it is well-tolerated with few serious issues.

Another study compared these two treatments and found both to be effective, but with some differences. Endovascular therapy often results in better overall health outcomes, while microsurgical clipping provides a more secure repair of the aneurysm.

Both treatments have their advantages and disadvantages, but overall, they are considered safe for most people. Prospective trial participants can find reassurance in the safety of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two distinct approaches to managing unruptured intracranial aneurysms. The first approach involves active intervention through microsurgical clipping or endovascular therapy, which aims to secure the aneurysm and prevent rupture proactively. This is different from the traditional method because it could offer more immediate protection against aneurysm rupture. The second approach focuses on conservative management, using regular monitoring and serial imaging to track aneurysm stability. This method allows patients to avoid immediate surgery, potentially reducing the risks associated with invasive procedures while still keeping an eye on the aneurysm's behavior. By comparing these methods, researchers hope to better understand which approach offers the best balance of safety and effectiveness for patients.

What evidence suggests that this trial's treatments could be effective for anxiety and depression in patients with unruptured intracranial aneurysms?

This trial will compare two approaches for managing unruptured intracranial aneurysms (UIAs): active intervention and conservative management. Participants in the treatment group will undergo either microsurgical clipping or endovascular therapy to secure the aneurysm and prevent rupture. Studies have shown that microsurgical clipping is particularly successful, with 96% of cases achieving good results in preventing rupture, though there is a small risk of negative outcomes (6.7%) and a 1.7% risk of death. Endovascular therapy, such as coiling, is also effective and generally has fewer negative outcomes than surgery, with some studies reporting negative outcomes in about 10% of cases. Both treatments aim to secure the aneurysm and reduce the risk of it bursting, which can be life-threatening. Participants in the observation group will undergo regular monitoring with serial imaging to track aneurysm stability, deferring interventional treatment unless changes indicate an increased risk of rupture. ^{1 5 6 7 8}

Who Is on the Research Team?

David J Altschul, MD

Principal Investigator

Associate Professor at The Leo M. Davidoff Department of Neurological Surgery at Montefiore

Are You a Good Fit for This Trial?

Inclusion Criteria

You do not have a brain aneurysm that has not ruptured.

You have an aneurysm in certain locations that cannot be treated with this procedure.

Your aneurysm is smaller than 4 millimeters.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the treatment group undergo microsurgical clipping or endovascular therapy, while those in the observation group are monitored with serial imaging

6 months

Regular visits for monitoring and treatment

Follow-up

Participants are monitored for changes in neurologic status, aneurysm rupture, and mental health outcomes using the HADS tool

18 months

Follow-up visits at 6 and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Clipping
• Endovascular Embolization

How Is the Trial Designed?

Group I: Treatment group Experimental Treatment 2 Interventions

Patients with unruptured intracranial aneurysms, opting for active intervention undergo microsurgical clipping or endovascular therapy to preemptively secure the aneurysm and prevent rupture.

Group II: Observation group Experimental Treatment 1 Intervention

Patients with unruptured intracranial aneurysms, opting for conservative management undergo regular monitoring with serial imaging to track aneurysm stability, deferring interventional treatment unless changes indicate an increased risk of rupture.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

The Bee Foundation

Collaborator

Trials

1

Recruited

200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10766286/

Global Outcomes for Microsurgical Clipping of Unruptured ... Available data report a risk of unfavorable outcome in 6.7% and a mortality of 1.7% after microsurgical clipping. ... However, the literature on ...

2. thejns.org thejns.org/view/journals/j-neurosurg/137/2/article-p352.xml

a prospective multicenter study with propensity score analysis in Again, the clipping cohort had superior adequate angiographic outcomes (96% vs 78%) but worse good clinical outcome (84% vs 97%), both of which ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0967586825003923

Endovascular coiling vs microsurgical clipping for ... The International Study of Unruptured Intracranial Aneurysms demonstrated that both modalities yield comparable outcomes in preventing ruptures for small to ...

4. ajnr.org ajnr.org/content/44/6/634

A Pragmatic Randomized Trial Comparing Surgical ... The study hypothesized that clipping would decrease the incidence of treatment failure from 13% to 4%, a composite primary outcome defined as ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3296500/

Endovascular Treatment of Unruptured Intracranial ... On the other hand, adverse outcomes after surgery or coiling of unruptured aneurysms were in the range of 25% and 10%, respectively. A report by Juvela et al, ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2529849624000467

Microsurgical clipping of unruptured intracranial aneurysms Microsurgery is a valid and safe technique, with 0% mortality and bleeding rates and 1,2% rate of severe morbidity in our series.

7. thejns.org thejns.org/view/journals/j-neurosurg/140/6/article-p1736.xml

Safety and efficacy of endovascular versus microsurgical ... The purpose of this study was to evaluate the safety and efficacy of MS versus EVT for unruptured WN-MCA aneurysms.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27624158/

a systematic analysis of observational studies Conclusions: While there are limitations to the data, EC resulted in a more favorable clinical outcome, and MC resulted in more robust aneurysm repair, for ...