Endovascular Thrombectomy for Stroke

(STEP Trial)

Recruiting at 40 trial locations

Overseen By Melissa Hoffman

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

2000 Participants Needed

Trial Summary

What is the purpose of this trial?

STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO).

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 Endovascular thrombectomy for stroke?

Research shows that endovascular thrombectomy is effective for treating certain types of strokes, especially when performed within 24 hours of symptom onset. It improves outcomes like disability-free survival and quality of life for patients with large-vessel blockages. ^{1 2 3 4 5}

Is endovascular thrombectomy generally safe for humans?

There is limited safety data available for endovascular thrombectomy, especially concerning complications during the procedure and its use in different populations like children and those on certain blood thinners. ^{6 7 8 9 10}

How is endovascular thrombectomy different from other stroke treatments?

Endovascular thrombectomy is unique because it involves physically removing a blood clot from a blocked artery in the brain using specialized devices, which is different from other treatments like clot-dissolving medications that work by breaking down the clot chemically. This treatment has been shown to be effective even in large-volume strokes, expanding its use beyond smaller strokes. ^{7 11 12 13 14}

Research Team

Tudor G Jovin, MD

Principal Investigator

The Cooper Health System

Raul G Nogueira, MD, FAHA

Principal Investigator

University of Pittsburgh

David Fiorella, MD, PhD

Principal Investigator

Stony Brook University

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

Jeffery L Saver, MD

Principal Investigator

University of California, Los Angeles

Jordan J Elm, PhD

Principal Investigator

Medical University of South Carolina

Adnan Siddiqui, MD, PhD

Principal Investigator

University at Buffalo

J Mocco, MD, MS

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 M3,4 or A1,2,3 or P1,2,3 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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States 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. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Endovascular thrombectomy: 31 hours from symptom onset. [2020]

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

Endovascular Thrombectomy for Pediatric Acute Ischemic Stroke: A Multi-Institutional Experience of Technical and Clinical Outcomes. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Late Thrombectomy in Clinical Practice : Retrospective Application of DAWN/DEFUSE3 Criteria within the German Stroke Registry. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Endovascular Thrombectomy for Ischemic Stroke Increases Disability-Free Survival, Quality of Life, and Life Expectancy and Reduces Cost. [2022]

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

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

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

Trial of Endovascular Thrombectomy for Large Ischemic Strokes. [2023]

8. United States 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. [2023]

9. United States 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. [2022]

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

Distal arterial occlusions in patients with mild strokes - is endovascular therapy superior to thrombolysis alone? [2020]

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

Endovascular treatment of acute ischemic stroke. [2013]

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

Endovascular Thrombectomy for the Treatment of Large Ischemic Stroke: A Systematic Review and Meta-Analysis of Randomized Control Trials. [2023]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Trials in thrombectomy for acute ischemic stroke: Describing the state of clinical research in the field. [2021]

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

Autopsy findings after intracranial thrombectomy for acute ischemic stroke: a clinicopathologic study of 5 patients. [2021]