Clipping vs Coiling for Brain Aneurysm

(MCAAT Trial)

Overseen By Sudeshna Bhattacharyna

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Contrast allergy, AVM, Consent issues, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate procedure

400 Participants Needed

Trial Summary

What is the purpose of this trial?

Intracranial aneurysms located on the middle cerebral artery (MCA) are considered by many surgeons to represent a distinct subgroup of aneurysms for which clipping may still be the best management option. Most MCA aneurysms are accessible, proximal control can readily be secured in case of rupture, and clip application can typically proceed without requiring the dissection of perforating arteries. In comparison, certain anatomic features of MCA aneurysms such as a wide neck, often including a branch artery origin, frequently render endovascular management more difficult. New endovascular devices were and continue to be introduced to address these anatomic difficulties, including stents, flow diverters, and intra-saccular flow disruptors (ISFDs) such as the WEB. Thus, while most aneurysms are increasingly treated with endovascular methods, many MCA aneurysm patients are still managed surgically, but convincing evidence of which management paradigm is best is lacking.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of this treatment for brain aneurysms?

Research shows that for severe cases of subarachnoid hemorrhage (bleeding in the space around the brain), patients treated with surgical clipping had better outcomes than those treated with endovascular coiling, with 69.16% of clipping cases resulting in a favorable outcome compared to 44.06% for coiling. ^{1 2 3 4 5}

Is clipping or coiling for brain aneurysms safe?

Both clipping and coiling are generally safe for treating brain aneurysms, but they have different risks. Clipping may have a higher risk of infection and brain tissue damage, while coiling tends to have a lower risk of death and disability. However, the long-term outcomes of coiling may not be as favorable as clipping. ^{3 6 7 8 9}

How does the treatment of clipping vs coiling for brain aneurysms differ from other treatments?

Clipping and coiling are two different methods for treating brain aneurysms. Clipping involves a surgical procedure to place a clip at the base of the aneurysm to stop blood flow, while coiling is a less invasive procedure where coils are inserted into the aneurysm to promote clotting and prevent rupture. Coiling is often chosen for patients with higher surgical risks or when the aneurysm's location makes surgery more challenging. ^{1 2 4 10 11}

Research Team

Tim Darsaut

Principal Investigator

University of Alberta Faculty of Medicine and Dentistry

Eligibility Criteria

This trial is for adults with a brain aneurysm located on the middle cerebral artery, which can be treated by surgery or endovascular methods. It includes those with recent or older ruptures (over 30 days old) who are in stable condition (WFNS grade 4 or less). People allergic to contrast material, unable to consent, with AVM-related aneurysms, or severe ruptures (WFNS grade 5) cannot join.

Inclusion Criteria

I am 18 years old or older.

My SAH condition is not the most severe.

I have at least one aneurysm in my brain's MCA vessel, whether it has burst or not.

Exclusion Criteria

I am unable to give consent myself.

I have an aneurysm linked to my AVM condition.

I cannot receive contrast material due to severe allergies or reactions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either surgical clipping or endovascular management of MCA aneurysms

Immediate procedure

Follow-up

Participants are monitored for treatment success and safety, including assessments for intracranial hemorrhage and residual aneurysm

5 years

Annual visits for imaging and assessments

Long-term follow-up

Continued monitoring for overall mortality and morbidity

5 years

Treatment Details

Interventions

• Endovascular management
• Surgical management

Trial Overview The study compares surgical clipping versus endovascular treatment for MCA aneurysms. Surgical clipping might be preferred due to easier access and control during rupture. Endovascular options include stents and flow disruptors but face challenges like wide necks of the aneurysm.

Participant Groups

Group I: Surgical management Active Control 1 Intervention

Group II: Endovascular management Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

In a review of 24 studies involving 31,865 patients, endovascular coiling was found to result in significantly lower disability and complications compared to neurosurgical clipping for treating unruptured intracranial aneurysms.

Clipping was associated with higher rates of short-term disability and complications, indicating that coiling may be the safer and more effective option for patients in the immediate aftermath of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular coiling versus neurosurgical clipping in patients with unruptured intracranial aneurysm: a systematic review. Hwang, JS., Hyun, MK., Lee, HJ., et al.[2021]

In a study of 48 patients with intracranial aneurysms, those treated with endovascular coiling had a better initial functional status (lower modified Rankin Scale score) compared to those who underwent surgical clipping, indicating a potentially safer option at the time of treatment.

At the one-year follow-up, the endovascular coiling group showed significant improvement in functional outcomes, while the surgical clipping group did not, suggesting that coiling may offer better long-term benefits, although no significant difference was found between the two groups overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of endovascular coiling and surgical clipping for the treatment of intracranial aneurysms: A prospective study. Taheri, Z., Harirchian, MH., Ghanaati, H., et al.[2020]

In a study of 179 severe subarachnoid hemorrhage (SAH) cases, direct microsurgical clipping resulted in a more favorable outcome (69.16% good recovery or moderate disability) compared to endovascular coiling (44.06%).

The choice between clipping and coiling is guided by specific clinical criteria, with clipping preferred for younger patients and those with more severe conditions, indicating its effectiveness in acute severe SAH cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of clipping and coiling in acute severe subarachnoid hemorrhage after international subarachnoid aneurysmal trial (ISAT) results. Kato, Y., Sano, H., Dong, PT., et al.[2005]

In a study of 366 patients with poor-grade ruptured aneurysms, endovascular coiling showed a higher unadjusted rate of favorable outcomes at 6 and 12 months compared to surgical clipping, but this difference was not statistically significant after adjusting for other factors.

Patients treated with endovascular coiling had a significantly higher risk of developing radiologic hydrocephalus compared to those treated with clipping, indicating a potential safety concern with the coiling method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Coiling versus Surgical Clipping for Poor-Grade Ruptured Intracranial Aneurysms: Postoperative Complications and Clinical Outcome in a Multicenter Poor-Grade Aneurysm Study. Zhao, B., Tan, X., Yang, H., et al.[2021]

In a study of 140 patients with anterior circulation aneurysms, endovascular coiling resulted in a more favorable neurological outcome at one year, with 80% of patients achieving a good outcome compared to 68.6% in the clipping group.

Coiling was associated with a lower mortality rate (1.4%) compared to clipping (4.3%), suggesting that coiling may be a safer and less invasive option for treating these aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aneurysmal Subarachnoid Hemorrhage: Outcome of Aneurysm Clipping Versus Coiling in Anterior Circulation Aneurysm. Wadd, IH., Haroon, A., Habibullah, ., et al.[2016]

In a study of 291 patients with unruptured intracranial aneurysms, surgical clipping was found to be more effective than endovascular treatment, with a lower incidence of treatment failure (9% vs. 19%) at one year.

While clipping showed better efficacy, it was associated with higher rates of neurologic deficits and longer hospital stays compared to endovascular treatment, indicating a trade-off between effectiveness and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms. Darsaut, TE., Findlay, JM., Bojanowski, MW., et al.[2023]

Endovascular coiling is currently preferred over microsurgical clipping for treating unruptured intracranial aneurysms (UIA) due to its lower associated risks of complications like cerebrospinal fluid leakage and infection, as well as reduced mortality and disability rates.

This study aims to provide a direct comparison of the long-term safety and efficacy of endovascular coiling versus surgical clipping in a randomized controlled trial, assessing outcomes such as disability and recurrence rates over 6 months and 1 year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To clip or to coil for unruptured intracranial aneurysm?: A protocol of randomized controlled trial. Huang, X., Yan, G., Qin, Z., et al.[2021]

In a study of 412 aneurysms treated with microsurgical clipping, 94.01% of unruptured aneurysms and 75.4% of ruptured aneurysms achieved favorable outcomes, indicating that this method is effective for both types of aneurysms.

Factors such as older age, higher baseline mRS scores, and posterior circulation location were linked to worse outcomes, suggesting that patient characteristics can influence the success of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Make Clipping Great Again: Microsurgery for Cerebral Aneurysms by Dual-Trained Neurosurgeons. Munich, SA., Vakharia, K., McPheeters, MJ., et al.[2020]

Surgical clipping is associated with lower mortality and reduced risk of rebleeding for patients with ruptured intracranial aneurysms (IAs), suggesting it may be the preferred treatment for these cases.

In contrast, clipping leads to a higher incidence of poor outcomes and bleeding for unruptured IAs compared to endovascular coiling, indicating that coiling may be safer for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosurgical Clipping versus Endovascular Coiling for Patients with Intracranial Aneurysms: A Systematic Review and Meta-Analysis. Jiang, Z., Chen, Y., Zeng, C., et al.[2020]

In a study of 30 patients treated with endovascular coil embolization for middle cerebral artery (MCA) aneurysms, complete obliteration was achieved in 93% of cases, showing that coiling can be as effective as surgical clipping, which had a similar success rate of 92%.

Coiling is particularly beneficial for patients with short M1 arteries or serious medical conditions, as it presents a lower risk of complications compared to clipping, with only 6.7% experiencing post-procedural infarctions and fewer severe complications overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular coiling of middle cerebral artery aneurysms as an alternative to surgical clipping. Kim, KH., Cha, KC., Kim, JS., et al.[2013]

Endovascular coiling is now the preferred treatment for ruptured intracranial aneurysms, showing benefits over surgical clipping according to the ISAT study, which is a multicenter randomized controlled trial.

The optimal management for unruptured intracranial aneurysms is still uncertain, as no randomized controlled trials have compared conservative management with surgical clipping or endovascular coiling; an ongoing trial aims to clarify whether active treatment improves outcomes compared to observation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current update on the randomized controlled trials of intracranial aneurysms. Yoon, W.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Endovascular coiling versus neurosurgical clipping in patients with unruptured intracranial aneurysm: a systematic review. [2021]

2. Iran pubmed.ncbi.nlm.nih.gov

Comparison of endovascular coiling and surgical clipping for the treatment of intracranial aneurysms: A prospective study. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

The effect of clipping and coiling in acute severe subarachnoid hemorrhage after international subarachnoid aneurysmal trial (ISAT) results. [2005]

4. United States pubmed.ncbi.nlm.nih.gov

Endovascular Coiling versus Surgical Clipping for Poor-Grade Ruptured Intracranial Aneurysms: Postoperative Complications and Clinical Outcome in a Multicenter Poor-Grade Aneurysm Study. [2021]

5. Pakistan pubmed.ncbi.nlm.nih.gov

Aneurysmal Subarachnoid Hemorrhage: Outcome of Aneurysm Clipping Versus Coiling in Anterior Circulation Aneurysm. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

To clip or to coil for unruptured intracranial aneurysm?: A protocol of randomized controlled trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Make Clipping Great Again: Microsurgery for Cerebral Aneurysms by Dual-Trained Neurosurgeons. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Neurosurgical Clipping versus Endovascular Coiling for Patients with Intracranial Aneurysms: A Systematic Review and Meta-Analysis. [2020]

10. Scotland pubmed.ncbi.nlm.nih.gov

Endovascular coiling of middle cerebral artery aneurysms as an alternative to surgical clipping. [2013]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Current update on the randomized controlled trials of intracranial aneurysms. [2021]