Envi™-SR Thrombectomy Device for Ischemic Stroke

(ENVI RCT Trial)

Recruiting at 3 trial locations

Overseen By NeuroVasc Clinical Affairs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NeuroVasc Technologies

Must be taking: IV t-PA

Must not be taking: Illicit drugs

Disqualifiers: Pregnancy, Renal failure, Hypertension, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

12 Participants Needed

Trial Summary

What is the purpose of this trial?

The study objective is to examine and compare clinical outcomes, as measured by Modified Rankin Scale (mRS) at 90 days (± 15 days) post treatment, and related performance characteristics of the Envi™-SR and concurrent parallel Control Devices currently cleared by the U.S. FDA for treatment of stroke.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on IV t-PA, it should be administered without delay and within three hours of stroke onset. It's best to discuss your current medications with the trial team to get specific guidance.

What data supports the effectiveness of the Envi™-SR Thrombectomy treatment for ischemic stroke?

The Trevo device, similar to the Envi™-SR, has shown promising results in achieving high recanalization rates (restoring blood flow) in patients with acute ischemic stroke, as reported in the TREVO study. This suggests that devices like the Envi™-SR could be effective in treating large vessel occlusions in stroke patients. ^{1 2 3 4 5}

What safety data exists for the Envi™-SR Thrombectomy Device and similar devices?

The available research does not provide specific safety data for the Envi™-SR Thrombectomy Device or its related names. However, advancements in thrombectomy devices have generally focused on improving safety and reducing complications during procedures. ^{1 2 4 5 6}

How is the Envi™-SR Thrombectomy device treatment different from other treatments for ischemic stroke?

The Envi™-SR Thrombectomy device is unique because it is designed to mechanically remove blood clots from large vessels in the brain, offering a direct and immediate way to restore blood flow in cases of acute ischemic stroke. Unlike traditional drug treatments that dissolve clots, this device physically retrieves the clot, which can be more effective for large or resistant clots. ^{2 3 4 5 7}

Research Team

Raul G Nogueira, MD

Principal Investigator

University of Pittsburgh Medical Center

Vitor Mendes-Pereira, MD, MSc

Principal Investigator

St Michael's Hospital and the University of Toronto

Eligibility Criteria

This trial is for adults who've had a recent ischemic stroke, can walk independently (pre-stroke mRS ≤ 2), and have an NIHSS score of at least 6. They must be able to start treatment within 24 hours of the stroke and follow the study schedule. Exclusions include pregnancy, severe allergies to contrast media, other recent strokes or interventions, drug abuse, certain blood conditions, and life expectancy under six months.

Inclusion Criteria

You have signs of a stroke in the front part of your brain as shown on imaging tests.

I was able to walk on my own before having a stroke.

I received IV t-PA treatment promptly when needed.

Exclusion Criteria

I am currently in a coma.

You are not expected to live for more than six months.

I have blockages in multiple blood vessels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mechanical thrombectomy using either the Envi™-SR or a control device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of Modified Rankin Score (mRS) at 90 days

90 days

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Envi™-SR Thrombectomy device
• Solitaire or Trevo Revascularization Device

Trial Overview The trial compares two mechanical thrombectomy devices: Envi™-SR versus FDA-cleared control devices like Solitaire or Trevo. It aims to see which device better improves patient outcomes using the Modified Rankin Scale after three months from treatment in patients with arterial blockages due to stroke.

Participant Groups

Group I: Envi™-SR Thrombectomy Device Experimental Treatment 1 Intervention

Mechanical Thrombectomy using the Envi™-SR Thrombectomy Device

Group II: Solitaire or Trevo Revascularization Device Active Control 1 Intervention

Mechanical Thrombectomy using the Solitaire or Trevo Revascularization Device

Envi™-SR Thrombectomy device is already approved in European Union, China, United States for the following indications:

Approved in European Union as Envi-SR for:

• Acute ischemic stroke due to large vessel occlusion

Approved in China as Envi-SR for:

• Under investigation for acute ischemic stroke due to large vessel occlusion

Approved in United States as Envi-SR for:

• Under investigation for acute ischemic stroke due to large vessel occlusion

Who Is Running the Clinical Trial?

NeuroVasc Technologies

Lead Sponsor

Trials

1

Recruited

560+

Findings from Research

In a preclinical study using a porcine model, the React68 and React71 aspiration catheters demonstrated effective recanalization rates for treating large vessel occlusion (LVO), showing no significant difference compared to the ACE68 catheter.

Both React68 and React71 catheters exhibited a strong safety profile, with no physical or neurological deficits observed in treated animals, and minimal tissue disruption without signs of inflammation or significant damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy Evaluation of Aspiration Thrombectomy With Large Bore Catheters in a Porcine Model. Jankowitz, BT., Gross, BA., Mintz, E., et al.[2020]

The NeVa™ thrombectomy device achieved a high first-pass recanalization rate of 56.8% and an overall successful recanalization rate of 95.8% in a study of 118 patients, indicating its effectiveness in treating large vessel occlusions.

The device demonstrated a good safety profile, with only 3.3% of patients experiencing symptomatic hemorrhage and a low rate of embolization into new territory (1.7%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Favorable first-pass recanalization rates with NeVa™ thrombectomy device in acute stroke patients: Initial clinical experience. Akpinar, CK., Ozdemir, AO., Gurkas, E., et al.[2023]

The Trevo Stentriever™ demonstrated a high recanalization rate of 91.7% in 60 patients with acute ischemic stroke due to large vessel occlusion, indicating its efficacy in restoring blood flow.

At 90 days post-treatment, 55% of patients achieved a favorable neurological outcome, and the device had a low rate of symptomatic intracerebral hemorrhage at 5%, suggesting it is a safe option for stroke intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurothrombectomy for the treatment of acute ischemic stroke: results from the TREVO study. Jansen, O., Macho, JM., Killer-Oberpfalzer, M., et al.[2022]

The NeVa thrombectomy device demonstrated a high rate of first-pass reperfusion success in treating various types of occlusive thrombi in acute ischemic stroke, with a final mTICI score of 97.9%, indicating effective blood flow restoration.

The device showed a favorable safety profile, with no device-related adverse events reported among the 145 patients studied, suggesting it is a safe option for mechanical thrombectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First pass results of mechanical thrombectomy with two-drop zone NeVaTM device. Bajrami, A., Ertugrul, O., Senadim, S., et al.[2022]

In a study of 122 patients with acute inferior STEMI, the Diver CE device and Guardwire Plus device showed similar effectiveness in improving ST-segment resolution and myocardial reperfusion, indicating both devices are safe and effective for use before PCI.

Both devices resulted in comparable rates of slow flow/no-reflow and major adverse cardiac events at 30 days, suggesting that the choice between Diver CE and Guardwire Plus does not significantly impact short-term clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diver CE versus Guardwire Plus for thrombectomy in patients with inferior myocardial infarction: a trial of aspiration of thrombus during primary angioplasty for inferior myocardial infarction. Yan, HB., Wang, J., Li, N., et al.[2016]

Recent advancements in endovascular thrombectomy devices have significantly enhanced the success rates and safety of the thrombectomy procedure, which is crucial for treating stroke patients.

The ongoing development of new technologies aims to further improve reperfusion rates and minimize complications during the procedure, indicating a strong focus on optimizing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel and emerging technologies for endovascular thrombectomy. Chartrain, AG., Awad, AJ., Mascitelli, JR., et al.[2017]

The NeVa™ thrombectomy device showed a high rate of successful reperfusion, achieving TICI ≥ 2b in 93% of patients after the final pass, indicating effective removal of blood clots in stroke patients.

The device demonstrated a strong safety profile with no serious adverse events or symptomatic intracerebral hemorrhages reported, along with favorable clinical outcomes, as 53% of patients had a modified Rankin Scale score of 0-2 at 90 days post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical thrombectomy with a novel stent retriever with multifunctional zones: Initial clinical experience with the NeVa™ thrombectomy device. Ribo, M., Requena, M., Macho, J., et al.[2021]

References

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

Safety and Efficacy Evaluation of Aspiration Thrombectomy With Large Bore Catheters in a Porcine Model. [2020]

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

Favorable first-pass recanalization rates with NeVa™ thrombectomy device in acute stroke patients: Initial clinical experience. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Neurothrombectomy for the treatment of acute ischemic stroke: results from the TREVO study. [2022]

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

First pass results of mechanical thrombectomy with two-drop zone NeVaTM device. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Diver CE versus Guardwire Plus for thrombectomy in patients with inferior myocardial infarction: a trial of aspiration of thrombus during primary angioplasty for inferior myocardial infarction. [2016]

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

Novel and emerging technologies for endovascular thrombectomy. [2017]

7. France pubmed.ncbi.nlm.nih.gov

Mechanical thrombectomy with a novel stent retriever with multifunctional zones: Initial clinical experience with the NeVa™ thrombectomy device. [2021]