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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination of procedures to safely remove blockages in the brain that cause strokes. The focus is on mechanical thrombectomy, which involves inserting a tube through the groin to reach and remove the blockage while temporarily reversing blood flow to reduce complications. This approach aims to lower the risk of a second stroke during the procedure. Ideal participants are those who have experienced large vessel strokes (blockage in a major brain artery) within the last 24 hours and meet specific criteria. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative procedure.

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 prior data suggests that this procedure is safe for stroke patients?

Research has shown that mechanical thrombectomy, a treatment for strokes, is generally safe. In one study, 95% of patients experienced no complications during or after the procedure, while only about 7.7% experienced symptomatic intracranial hemorrhage, a type of bleeding in the brain. Another study found that using this procedure within 24 hours of a stroke is safe. These findings suggest that most patients tolerate the procedure well. The current trial is testing a new approach called blood flow reversal to assess its safety. As this is an early phase trial, researchers are still carefully studying the safety of this new method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mechanical thrombectomy using blood flow reversal for stroke because it offers a novel approach to clearing blockages in the brain. Unlike standard treatments like intravenous thrombolysis, which dissolves clots chemically, this method involves mechanically removing the clot while reversing blood flow to prevent fragments from causing further blockages. This technique aims to improve the safety and efficacy of clot removal, potentially leading to better outcomes for patients with large vessel occlusions. By directly targeting the blockage with a stent retriever while managing blood flow, it could reduce the risk of additional strokes and enhance recovery times.

What evidence suggests that this combination of procedures is effective for stroke patients?

Research has shown that mechanical thrombectomy works well for people with a major blockage in a brain artery. In this trial, participants will undergo mechanical thrombectomy using blood flow reversal. Studies have found that this approach improves blood flow in the brain and leads to better recovery compared to regular treatments. Patients who underwent this procedure were more likely to regain independence. Reversing the blood flow during the procedure lowers the risk of clots breaking off and causing additional problems. Overall, this combined method aims to make the thrombectomy more successful and safe. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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

Last known well less than 24 hours

ASPECTS of 4 or above

More than 20 ml penumbra on CTP

Exclusion Criteria

Absent family members to consent

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1.

strokejournal.org

strokejournal.org/article/S1052-3057(21)00254-8/abstract

Mechanical Thrombectomy Improves Outcome for Large ...

LVO patients receiving thrombectomy were significantly more likely to return to independent living compared to those managed medically (n = 4/6, ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.121.022880

Mechanical Thrombectomy Up to 24 Hours in Large Vessel ...

We demonstrated the efficacy of mechanical thrombectomy in patients with large vessel occlusion with perfusion scans between 2 time windows (<6 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10718368/

Mechanical thrombectomy for AIS from large vessel occlusion

When compared to standard medical treatment alone, mechanical thrombectomy appears to be effective and safe for the treatment of patients with AIS-Large Vessel ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2590139725000213

Outcomes of patients with acute large anterior circulation ...

Conclusions: Without reperfusion treatment, patients with LVO had poor outcomes. Mechanical thrombectomy improved recanalization rates, resulting in better ...

5.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.895182/full

Predictive Factors for Clinical Outcome After Direct ...

Background: Recent trials including DIRECT-MT, DEVT, and SKIP have found that direct mechanical thrombectomy (MT) is equally effective as ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8581036/

Mechanical Thrombectomy for Acute Stroke Due to Large- ...

Purpose: To evaluate the safety and efficacy of mechanical thrombectomy (MT) for acute stroke due to large vessel occlusion (LVO), presenting ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04526756

Mechanical Thrombectomy for Acute Large Vessel ...

A excellent clinical outcome was defined as a modified Rankin Scale score of 0 to 1 at 90 days. Symptomatic intracranial hemorrhage(sICH) was the safety outcome ...

8.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000004184

Blood pressure levels post mechanical thrombectomy and ...

Recent randomized controlled clinical trials (RCTs) have provided overwhelming evidence that timely mechanical thrombectomy (MT) in patients with LVO is safe ...

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022510X23000540

Mechanical thrombectomy for acute large vessel occlusion ...

Favorable outcome was achieved in 49% (95% CI: 34%–64%), and 95% were free of complications. A total of 3 patients (7.7%) had sICH. In an ...