Mechanical Thrombectomy for Stroke

Overseen By Abigail Hasan, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: MediSys Health Network

Disqualifiers: Posterior occlusion, Patent foramen ovale, DVT, others

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

Compensation: Varies

Number of Visits: 4

Duration: Less than 30 minutes

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to reduce the chance of complications during mechanical thrombectomy, which is a procedure to remove blockages from the brain. This study is combining two established and standard procedures for the first time so that the patient may benefit from both and reduce the chance of another stroke during the procedure. Our main goal is to show that this combination is safe, feasible, and effective for stroke patients. The combined procedures are described as follows: 1. Mechanical Thrombectomy: while the patient is asleep under light or general anesthesia, a surgical cut will be made in their groin to access the common femoral artery. A catheter will be inserted into this cut so that a wire can advance through the artery. Using an imaging technique called angiography, a blueprint is used to advance the wire from an artery in their groin, to their neck, into their brain and locate the target blockage. Once the target is located, more wires and catheters are used to finetune the extraction process. A stent retriever is placed on standby before removing the blockage. 2. Reversal Flow: before the mechanical thrombectomy is completed, a surgical cut will be made to the other groin that has not been operated on. A catheter and wire are used to access the newly punctured femoral vein. A device called an aspiration filter will connect a catheter from their femoral vein to an aspiration catheter at the target site. Once this connection is complete, full removal of the blockage by the stent retriever will occur while blood flow is reversed.

Will I have to stop taking my current medications?

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.

What data supports the effectiveness of the treatment Mechanical Thrombectomy via Blood Flow Reversal for stroke?

Research shows that mechanical thrombectomy is effective in reopening blocked blood vessels in the brain for stroke patients, with good outcomes in 33% to 71% of cases. This suggests that the treatment can be beneficial, although there is room for improvement to help more patients. ^{1 2 3 4 5}

Is mechanical thrombectomy generally safe for humans?

Mechanical thrombectomy is generally considered safe, but like any medical procedure, it can have complications. Studies have shown that understanding and managing these potential complications is important for safe use in treating strokes. ^{6 7 8 9 10}

How is the treatment 'Mechanical Thrombectomy via Blood Flow Reversal' different from other treatments for stroke?

Mechanical Thrombectomy via Blood Flow Reversal is unique because it involves reversing blood flow to remove a blood clot, which is different from traditional methods that use stent retrievers or aspiration devices. This approach may offer a novel way to improve blood flow restoration in stroke patients. ^{5 11 12 13 14}

Eligibility Criteria

This trial is for stroke patients who can undergo a procedure to remove brain blockages. They should be able to tolerate anesthesia and have accessible arteries in their groins for catheter insertion. Specific eligibility details are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

I am over 18 years old.

More than 20 ml penumbra on CTP

Last known well less than 24 hours

Exclusion Criteria

I have a blood clot in a deep vein in my leg.

Absent family members to consent

Large established stroke on CT/CT Perfusion with ASPECTS <5

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Mechanical thrombectomy with blood flow reversal is performed to remove blockages from the brain

Less than 30 minutes

1 visit (in-person)

Post-procedure Monitoring

Patients are monitored in the intensive care unit and then transferred to the stroke unit for further observation

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

3 visits (in-person) at 30 days, 90 days, and 3 months

Treatment Details

Interventions

• Mechanical Thrombectomy via Blood Flow Reversal

Trial Overview The study tests combining mechanical thrombectomy with blood flow reversal using the BOBBY balloon guide catheter. The aim is to see if this new method reduces complications during the clot removal process and prevents further strokes while being safe and effective.

Participant Groups

Group I: Stroke patients with LVO Experimental Treatment 1 Intervention

Eligible patients for the study will be stroke patients with large vessel occlusion who meet inclusion criteria. * Age \> 18-year-old * Last known well less than 24 hours * Large vessel occlusion of intra-cranial ICA or MCA M1 segment * ASPECTS of 4 or above * Baseline modified Rankin scale of 3 or less. * More than 20 ml penumbra on CTP * Less than 100 ml infarct core on CTP Before the mechanical thrombectomy is completed, a surgical cut will be made to the other groin that has not been operated on. A catheter and wire are used to access the newly punctured femoral vein. A device called an aspiration filter will connect a catheter from your femoral vein to an aspiration catheter at the target site. Once this connection is complete, full removal of the blockage by the stent retriever will occur while blood flow is reversed.

Who Is Running the Clinical Trial?

MediSys Health Network

Lead Sponsor

Trials

5

Recruited

250+

Findings from Research

In a study of 533 patients who underwent mechanical thrombectomy (MT) for large vessel occlusion stroke, only 18.2% achieved favorable outcomes despite failed recanalization, highlighting the challenges in treating this condition.

Factors associated with better outcomes after failed MT included younger age, lower initial stroke severity (NIHSS), fewer MT attempts, and less deterioration in brain imaging scores, suggesting these could guide future treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical thrombectomy failure in anterior circulation strokes: Outcomes and predictors of favorable outcome. Marnat, G., Gory, B., Sibon, I., et al.[2022]

Mechanical thrombectomy is an effective treatment for acute stroke caused by large vessel occlusions, significantly improving patient outcomes, but only 33-71% of patients achieve good results after the procedure.

There is potential to enhance the effectiveness of endovascular therapy and expand eligibility for treatment by combining it with strategies that improve blood flow and protect blood vessels in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Reperfusion Therapies in the Era of Mechanical Thrombectomy. Linfante, I., Cipolla, MJ.[2022]

In a study of 49 patients who underwent mechanical thrombectomy for acute intracranial major vessel occlusion, successful recanalization was achieved in 81.6% of cases, indicating the procedure's efficacy in restoring blood flow.

Long-term follow-up revealed that 16.2% of patients experienced reocclusion or severe stenosis of the treated vessels, highlighting the need for ongoing monitoring, especially in those with middle cerebral artery occlusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term magnetic resonance angiography follow-up for recanalized vessels after mechanical thrombectomy. Enomoto, Y., Yoshimura, S., Egashira, Y., et al.[2020]

Elderly patients (aged 80 and above) undergoing mechanical thrombectomy for stroke have a significantly higher mortality rate (48%) compared to younger patients (15%), indicating that age adversely affects prognosis after the procedure.

Despite the higher mortality in older patients, those who survive show similar rates of good functional outcomes at discharge (38% for elderly vs. 40% for younger patients), suggesting that age does not impact the level of disability among survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher rates of mortality but not morbidity follow intracranial mechanical thrombectomy in the elderly. Loh, Y., Kim, D., Shi, ZS., et al.[2022]

The fluid model (FM) for preparing thrombi demonstrated superior mechanical properties compared to the static model (SM), with longer tensile lengths and significantly less breakage during catheter injection tests, indicating better stability for thrombectomy devices.

Thrombi created using the FM closely resembled the histological structure of actual thromboemboli from stroke patients, suggesting that this method can effectively simulate real-world conditions for evaluating thrombectomy devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New method of thrombus preparation using a fluid model for evaluation of thrombectomy devices in a swine model. Shao, Q., Zhu, L., Li, T., et al.[2014]

In a study of 984 acute ischemic stroke patients, those with M2 segment middle cerebral artery occlusions achieved similar rates of successful reperfusion and good functional outcomes compared to those with M1 occlusions, indicating that mechanical thrombectomy can be effective for both types of occlusions.

However, patients with M2 occlusions experienced significantly higher rates of symptomatic intracranial hemorrhage (4% vs. 1% for M1), suggesting a potential safety concern that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle Cerebral Artery M2 Thrombectomy in the STRATIS Registry. Jumaa, MA., Castonguay, AC., Salahuddin, H., et al.[2022]

In a study of 28 patients with ischemic stroke undergoing endovascular thrombectomy, the procedure appeared to be safe for those on non-vitamin K antagonist oral anticoagulants, with only 1 patient experiencing symptomatic intracranial hemorrhage despite a 46% rate of any intracranial hemorrhage.

Successful reperfusion was achieved in 59% of cases, and at 3 months, 19% of patients had a favorable functional outcome, indicating that thrombectomy can be effective in this patient population, although further research with larger cohorts is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Endovascular Thrombectomy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants. Purrucker, JC., Wolf, M., Haas, K., et al.[2022]

Mechanical thrombectomy (MT) is safe and effective for treating acute stroke patients with emergent large vessel occlusion (ELVO) even when they have a high international-normalized ratio (INR) greater than 1.7, as shown in a study of 315 patients.

The study found no significant differences in rates of symptomatic intracranial hemorrhage, 3-month mortality, successful reperfusion, or functional independence between patients with high INR and those with normal INR, indicating that high INR does not adversely affect MT outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical thrombectomy outcomes in large vessel stroke with high international normalized ratio. Pandhi, A., Tsivgoulis, G., Ishfaq, MF., et al.[2019]

Mechanical thrombectomy (mTE) has a low incidence of clinically relevant complications, with vascular injuries occurring in 1-5% and emboli in 5-9% of cases, but effective prevention and management strategies can enhance safety during the procedure.

Long-term side effects such as stenoses or occlusions in treated vessels occur in 4-10% of cases, but most are asymptomatic, indicating that while complications can arise, they are generally manageable and do not significantly impact patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mechanical thrombectomy: Acute complications and delayed sequelae]. Kurre, W., Bäzner, H., Henkes, H.[2018]

Mechanical thrombectomy (MT) for isolated posterior cerebral artery occlusions (IPCAOs) demonstrated a high successful recanalization rate of 86%, with nearly half of the patients achieving complete recanalization on the first attempt.

The procedure showed a safety profile with a 7% rate of symptomatic intracranial hemorrhage and an in-hospital mortality rate of 9.3%, while 59% of patients experienced early neurological improvement, indicating potential efficacy in treating this type of stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and safety of thrombectomy for isolated occlusions of the posterior cerebral artery: a multicenter experience and systematic literature review. Meyer, L., Papanagiotou, P., Politi, M., et al.[2021]

A new in vivo model using swine was developed to study mechanical thrombectomy, allowing for clear visualization of thrombus behavior during angiographic procedures, which is crucial for understanding and improving stroke interventions.

The model demonstrated that the preformed thrombus was stable and did not cause any local or systemic reactions, indicating its safety for use in evaluating mechanical devices for clot retrieval in acute stroke situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A dedicated animal model for mechanical thrombectomy in acute stroke. Gralla, J., Schroth, G., Remonda, L., et al.[2022]

The EmboTrap device achieved a high recanalization success rate of 90% in 80 patients with acute ischemic stroke, indicating its efficacy in restoring blood flow in large vessel occlusions.

The procedure was found to be safe, with only 6% of patients experiencing distal emboli and a low rate of complications, including 6% symptomatic intracranial hemorrhage, suggesting that EmboTrap is a reliable option for stroke treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter initial experience with the EmboTrap device in acute anterior ischemic stroke. Bourcier, R., Abed, D., Piotin, M., et al.[2019]

In a study involving 10 swine and 20 cranial vessels, the proximal aspiration device (Vasco35) demonstrated a faster application with a low complication rate (3% thromboembolic events), but had a lower success rate (39.4%) in retrieving thrombotic material compared to the distal basket-like device (Catch), which had an 82.6% success rate.

While the distal device was more effective at removing thrombus, it increased the risk of vessel wall irritation and embolic events (26%), unless proximal balloon occlusion was used, highlighting a trade-off between efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical thrombectomy for acute ischemic stroke: thrombus-device interaction, efficiency, and complications in vivo. Gralla, J., Schroth, G., Remonda, L., et al.[2016]

Mechanical thrombectomy is now the standard treatment for acute ischemic stroke caused by large vessel occlusion, with established guidelines for its use.

There is ongoing research into various thrombectomy techniques and devices, but currently, there is no clear evidence showing that one technique significantly improves clinical outcomes over another.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of mechanical thrombectomy techniques for acute ischemic stroke. Munoz, A., Jabre, R., Orenday-Barraza, JM., et al.[2023]

References

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

Mechanical thrombectomy failure in anterior circulation strokes: Outcomes and predictors of favorable outcome. [2022]

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

Improving Reperfusion Therapies in the Era of Mechanical Thrombectomy. [2022]

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

Long-term magnetic resonance angiography follow-up for recanalized vessels after mechanical thrombectomy. [2020]

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

Higher rates of mortality but not morbidity follow intracranial mechanical thrombectomy in the elderly. [2022]

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

New method of thrombus preparation using a fluid model for evaluation of thrombectomy devices in a swine model. [2014]

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

Middle Cerebral Artery M2 Thrombectomy in the STRATIS Registry. [2022]

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

Safety of Endovascular Thrombectomy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Mechanical thrombectomy outcomes in large vessel stroke with high international normalized ratio. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[Mechanical thrombectomy: Acute complications and delayed sequelae]. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Feasibility and safety of thrombectomy for isolated occlusions of the posterior cerebral artery: a multicenter experience and systematic literature review. [2021]

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

A dedicated animal model for mechanical thrombectomy in acute stroke. [2022]

12. France pubmed.ncbi.nlm.nih.gov

Multicenter initial experience with the EmboTrap device in acute anterior ischemic stroke. [2019]

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

Mechanical thrombectomy for acute ischemic stroke: thrombus-device interaction, efficiency, and complications in vivo. [2016]

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

A review of mechanical thrombectomy techniques for acute ischemic stroke. [2023]