Endovascular Thrombectomy for Stroke

(STEP Trial)

Recruiting at 43 trial locations

Overseen By Jordan Elm

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Septic embolus, Seizure, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

1600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve treatment for patients with acute ischemic stroke, particularly those with blocked large or medium blood vessels in the brain. It will compare two approaches: endovascular thrombectomy (a procedure to remove clots from blood vessels) and standard medical treatment. Individuals who have experienced a stroke with noticeable symptoms within the last 24 hours and have specific types of vessel blockages may be suitable candidates for this study.

As an unphased trial, this study provides patients the opportunity to contribute to important research that could enhance future stroke treatments.

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 endovascular thrombectomy is safe for stroke patients?

Research has shown that endovascular thrombectomy (EVT) is generally safe for individuals who have experienced a sudden stroke due to a blocked blood vessel. Studies have found that EVT can successfully restore blood flow in the brain and lead to positive recovery outcomes. One study found that EVT is safe and effective even for patients with larger areas of brain damage. Another review examined the use of EVT more than 24 hours after a stroke began and still found good results, suggesting it is well-tolerated.

While some risks exist, the benefits of reducing stroke damage usually outweigh them. Overall, EVT is a promising and safe option for many stroke patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about endovascular thrombectomy for stroke patients because it offers a direct approach to removing clots from blocked blood vessels in the brain. Unlike traditional treatments that rely solely on clot-dissolving medications, which can take time to work and might not be effective for all clot types, this procedure physically removes the obstruction. This method can potentially restore blood flow more rapidly and effectively, especially for patients with medium or distal vessel occlusions. By expanding the indication to include patients with mild symptoms or distal occlusions, the hope is to improve outcomes for a broader group of stroke patients, potentially reducing long-term disability.

What evidence suggests that endovascular thrombectomy could be effective for acute ischemic stroke?

Research shows that endovascular thrombectomy, a procedure to remove a blood clot, greatly improves recovery for patients who have had a severe stroke due to a blocked large blood vessel. Studies have found it more effective at reducing disability than medication alone. This trial will compare endovascular thrombectomy with medical management in two patient groups: those with medium/distal occlusions and those with low NIHSS scores. The procedure often restores blood flow successfully, leading to better recovery. Even when performed more than 24 hours after stroke onset, it still provides benefits. Overall, strong evidence supports the effectiveness of this treatment in aiding stroke recovery. ^{4 5 6 7 8}

Who Is on the Research Team?

Raul G Nogueira, MD, FAHA

Principal Investigator

University of Pittsburgh

David Fiorella, MD, PhD

Principal Investigator

Stony Brook University

Jeffery L Saver, MD

Principal Investigator

University of California, Los Angeles

Adnan Siddiqui, MD, PhD

Principal Investigator

University at Buffalo

J Mocco, MD, MS

Principal Investigator

MOUNT SINAI HOSPITAL

Tudor G Jovin, MD

Principal Investigator

The Cooper Health System

Jordan J Elm, PhD

Principal Investigator

Medical University of South Carolina

Eva A Mistry, MBBS, MSCI

Principal Investigator

University of Cincinnati

Pooja Khatri, MD

Principal Investigator

University of Cincinnati

Colin P Derdeyn, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for individuals who are suspected to have an acute ischemic stroke caused by a blockage in a large or medium-sized artery in the brain. They must be eligible for treatment under the STEP PLATFORM guidelines.

Inclusion Criteria

This criterion seems to be incomplete or lacks context for a proper translation.

I am suspected to have had a stroke caused by a blood clot.

I have a blockage in a large or medium brain vessel.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Endovascular Therapy (EVT) or Medical Management (MM) for acute ischemic stroke

24 hours

In-hospital treatment

Follow-up

Participants are monitored for neurological deficits, intracranial hemorrhage, and global disability

90 days

Multiple follow-up assessments

Outcome Assessment

Assessment of mortality and other long-term outcomes

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Endovascular thrombectomy

Trial Overview The study is testing whether removing blood clots from blocked brain arteries (endovascular thrombectomy) using FDA-approved devices, along with medical management, can improve outcomes after an acute ischemic stroke.

How Is the Trial Designed?

Group I: Endovascular Therapy (EVT) Indication Expansion Domain: Medium/Distal Occlusions Strata Experimental Treatment 2 Interventions

Adult patients with acute cerebral ischemia within 24 hours of last known who have Medium Vessel Occlusion (MVO) with Non-dominant/Co-dominant M2 occlusion or Distal Medium Vessel Occlusion (DMVO) patients with M3 occlusion will be randomized to receive one of two strategies: * Endovascular Therapy (EVT) * Medical Management (MM)

Group II: Endovascular Therapy (EVT) Indication Expansion Domain: Low NIHSS Strata Experimental Treatment 2 Interventions

Adult patients with acute cerebral ischemia within 24 hours of last known well who have large vessel occlusion (LVO) and mild deficits/low NIHSS (NIHSS 0-5) will be randomized to receive one of two strategies: * Endovascular Therapy (EVT) * Medical Management (MM)

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Stony Brook University

Collaborator

Trials

225

Recruited

41,700+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

Berry Consultants

Collaborator

Trials

16

Recruited

58,200+

MOUNT SINAI HOSPITAL

Collaborator

Trials

44

Recruited

17,000+

The Cooper Health System

Collaborator

Trials

82

Recruited

35,600+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

In a study of 21 pediatric patients undergoing endovascular thrombectomy for acute ischemic stroke, 83% achieved successful recanalization, indicating the procedure's efficacy in treating large-vessel occlusions in children.

Significant clinical improvements were observed, with a mean reduction in the Pediatric National Institutes of Health Stroke Scale score from 13 at presentation to 2 at discharge, and 86% of patients had favorable outcomes (mRS score of 0 to 2) by 90 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Thrombectomy for Pediatric Acute Ischemic Stroke: A Multi-Institutional Experience of Technical and Clinical Outcomes. Ravindra, VM., Alexander, M., Taussky, P., et al.[2021]

In a 5-year study of 66 patients undergoing endovascular thrombectomy for acute ischemic stroke, 53% achieved a favorable outcome (mRS 0-2) at 90 days, indicating the procedure's effectiveness in real-world settings.

Successful recanalization was achieved in 68% of cases, and higher scores on the Alberta Stroke Program Early CT Score (ASPECTS) and the thrombolysis in cerebral infarction (TICI) grading system were independently associated with better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome Evaluation of Acute Ischemic Stroke Patients Treated with Endovascular Thrombectomy: A Single-Institution Experience in the Era of Randomized Controlled Trials. Sarzetto, F., Gupta, S., Alotaibi, NM., et al.[2017]

In a study of 1917 patients who underwent thrombectomy, only 11% were treated within 6-24 hours, and those who were trial-ineligible had similar rates of good outcomes (27%) compared to trial-eligible patients (20%), indicating that eligibility criteria may not significantly impact clinical outcomes in real-world settings.

Patients with large CT perfusion imaging lesions who were trial-ineligible experienced more hemorrhagic complications (33%) and worse outcomes, suggesting that careful patient selection is crucial to minimize risks during late thrombectomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late Thrombectomy in Clinical Practice : Retrospective Application of DAWN/DEFUSE3 Criteria within the German Stroke Registry. Herzberg, M., Scherling, K., Stahl, R., et al.[2023]

Endovascular stroke therapy has significantly improved the treatment of acute ischemic stroke over the past decade, leading to better patient outcomes.

The article discusses the scientific basis and evidence supporting endovascular revascularization, along with technical details and case examples of various thrombectomy methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular treatment of acute ischemic stroke. Natarajan, SK., Eller, JL., Snyder, KV., et al.[2013]

Endovascular thrombectomy in children with acute ischemic stroke due to large-vessel occlusion shows high efficacy, with 88.5% achieving successful recanalization and a significant reduction in stroke severity (mean NIH Stroke Scale score reduction of 7.37).

Children experienced better outcomes compared to adults, including higher rates of good neurological recovery (76.1% vs. 46.0%), fewer major complications (3.6% vs. 30.4%), and lower mortality rates (1.0% vs. 12.9%), suggesting that this treatment is both safe and effective for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do children fare compared with adults? Comparing relative outcomes after thrombectomy for acute ischemic stroke due to large-vessel occlusion. Findlay, MC., Grandhi, R., Nelson, JR., et al.[2023]

In a study of 4799 patients undergoing endovascular thrombectomy for large vessel occlusion strokes, the cumulative incidence of complications was found to be 201 per 1000 patients, with significant associations between ongoing antiplatelet therapy and specific occlusion sites leading to higher risks of subarachnoid hemorrhage and arterial perforation.

Complications such as symptomatic intracerebral hemorrhage and subarachnoid hemorrhage were linked to worse functional outcomes and increased mortality at three months, highlighting the importance of identifying risk factors to improve patient management and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of mechanical thrombectomy for acute ischemic stroke: Incidence, risk factors, and clinical relevance in the Italian Registry of Endovascular Treatment in acute stroke. Salsano, G., Pracucci, G., Mavilio, N., et al.[2022]

Endovascular thrombectomy significantly improves functional outcomes in patients with large-volume ischemic strokes compared to medical management, based on a meta-analysis of three randomized trials involving 1011 participants.

While there is a trend toward a higher risk of symptomatic intracranial hemorrhage in the thrombectomy group, the overall risk of significant complications does not exceed that of medical management, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Thrombectomy for the Treatment of Large Ischemic Stroke: A Systematic Review and Meta-Analysis of Randomized Control Trials. Atchley, TJ., Estevez-Ordonez, D., Laskay, NMB., et al.[2023]

Endovascular thrombectomy is an effective treatment for patients with symptomatic intracranial large-vessel occlusion, showing benefits even up to 24 hours after symptom onset for those who were functionally independent before the stroke.

This case report suggests that thrombectomy may also be beneficial beyond the 24-hour window, as demonstrated in a young woman who received the intervention after this timeframe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular thrombectomy: 31 hours from symptom onset. Beharry, J., Duncan, R., Krauss, M., et al.[2020]

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]

In a study of 94 patients with mild stroke syndromes and distal vessel occlusions, endovascular thrombectomy (EVT) showed similar rates of excellent and good outcomes compared to intravenous thrombolysis (IVT), with 75% and 70% achieving excellent outcomes respectively.

However, EVT was associated with a higher risk of intracranial bleeding (13.3% vs. 1.6% for IVT) and significantly higher mortality (13.3% vs. 1.6%), suggesting that while EVT can be effective, it carries increased safety risks that must be carefully considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distal arterial occlusions in patients with mild strokes - is endovascular therapy superior to thrombolysis alone? Nagel, S., Pfaff, J., Herweh, C., et al.[2020]

In a study of 70 patients with large vessel occlusion ischemic stroke, those who underwent endovascular thrombectomy after alteplase treatment showed significantly better disability-weighted utility scores and longer life expectancy compared to those who received alteplase only.

Patients in the thrombectomy group experienced shorter hospital stays and lower overall acute care costs, saving an average of $4,365 per patient while also gaining more quality-adjusted life years (QALYs) and experiencing improved long-term survival and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Thrombectomy for Ischemic Stroke Increases Disability-Free Survival, Quality of Life, and Life Expectancy and Reduces Cost. Campbell, BCV., Mitchell, PJ., Churilov, L., et al.[2022]

Endovascular thrombectomy significantly improved functional outcomes in patients with large ischemic strokes compared to medical care alone, with a generalized odds ratio of 1.51 indicating better recovery at 90 days.

While thrombectomy was effective, it was associated with some vascular complications, including arterial access-site issues and vessel perforations, but the rates of symptomatic intracranial hemorrhage were low in both treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of Endovascular Thrombectomy for Large Ischemic Strokes. Sarraj, A., Hassan, AE., Abraham, MG., et al.[2023]

A total of 196 clinical trials on endovascular thrombectomy for ischemic stroke were identified, with 82.1% initiated in the last 5 years, indicating a rapid increase in research activity in this area.

Most trials focused on the safety and efficacy of thrombectomy devices and procedural aspects, with a significant number funded by academic centers, highlighting the collaborative effort in advancing stroke treatment technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trials in thrombectomy for acute ischemic stroke: Describing the state of clinical research in the field. Martini, ML., Neifert, SN., Lara-Reyna, JJ., et al.[2021]

In a review of 5 patients who underwent endovascular thrombectomy using the MERCI and Penumbra devices, all patients achieved partial recanalization, but they also exhibited extensive cerebral infarcts and complications such as hemorrhagic transformations after the procedure.

The study highlighted that complicated atherosclerosis was a common finding in the patients' basal arteries, suggesting that pre-existing vascular conditions may have contributed to the severity of their strokes and subsequent outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autopsy findings after intracranial thrombectomy for acute ischemic stroke: a clinicopathologic study of 5 patients. Yin, NS., Benavides, S., Starkman, S., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12184276/

Safety and Efficacy of Endovascular Thrombectomy for ... There is limited evidence regarding outcomes of endovascular thrombectomy (EVT) in patients with acute ischemic stroke after cardiac surgery ...

2. strokejournal.org strokejournal.org/article/S1052-3057(24)00651-7/fulltext

Endovascular thrombectomy for acute ischemic stroke with ... Primary outcomes were successful reperfusion (modified-Treatment in Cerebral Infarction (mTICI) score 2b-3), and favorable functional outcomes ( ...

3. ahajournals.org ahajournals.org/doi/10.1161/SVIN.124.001581

Endovascular Therapy in Patients With Acute Ischemic ... Endovascular therapy is highly effective in improving functional outcomes in patients with acute ischemic stroke from large vessel occlusion ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878875025002992

Efficacy and Safety of Endovascular Thrombectomy for ... We performed a systematic review and meta-analysis to examine the outcomes of EVT in patients with acute ischemic stroke beyond 24 hours from onset.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2214403

Trial of Endovascular Thrombectomy for Large Ischemic ... Endovascular thrombectomy has been shown to be more effective in reducing disability than medical therapy alone in selected patients with ischemic stroke.

6. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.040531

Safety and Efficacy of Endovascular Thrombectomy for ... There is limited evidence regarding outcomes of endovascular thrombectomy (EVT) in patients with acute ischemic stroke after cardiac surgery ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39719206/

Endovascular thrombectomy for acute ischemic stroke with ... Primary outcomes were successful reperfusion (modified-Treatment in Cerebral Infarction (mTICI) score 2b-3), and favorable functional outcomes (3-month modified ...

8. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(24)00278-3/fulltext

Endovascular thrombectomy for acute ischaemic stroke ... The TENSION trial showed the safety and efficacy of endovascular thrombectomy in patients with ischaemic stroke and large infarct at 90 days. We ...