Envi™-SR Thrombectomy Device for Ischemic Stroke

(ENVI RCT Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Envi™-SR thrombectomy device, designed to remove blood clots in stroke patients. The goal is to determine if this device performs as well as other FDA-approved devices for stroke treatment. Participants should have experienced an ischemic stroke, where a blood clot blocks blood flow to the brain, and must begin treatment within 24 hours of the stroke. The trial seeks individuals who could walk unaided before their stroke and are experiencing significant stroke symptoms. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance stroke treatment options.

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 prior data suggests that the Envi™-SR Thrombectomy Device is safe for treating ischemic stroke?

Research shows that devices like the Envi™-SR, used to treat strokes, are generally well-tolerated. These devices remove blood clots from the brain, which is crucial for patients experiencing a stroke due to a blocked blood vessel.

Studies on similar devices have shown they are usually safe. These devices have been used for some time and are approved for treating strokes, indicating relative safety. Serious side effects are rare, but as with any medical procedure, risks such as bleeding or damage to blood vessels exist.

The Envi™-SR is a newer version of these devices, designed for improved performance. While specific safety data for the Envi™-SR might not be fully available yet, it builds on the safety of earlier devices. Prospective clinical trial participants can find some reassurance in these findings but should still discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The Envi™-SR Thrombectomy device is unique because it may offer a more efficient and potentially safer way to remove blood clots in the brain caused by ischemic strokes. While standard devices like the Solitaire and Trevo revascularization devices are already effective, researchers are excited about the Envi™-SR because it promises enhanced clot retrieval with possibly fewer complications. This could mean faster recovery times and better outcomes for stroke patients, which is why there's a lot of anticipation around this new approach.

What evidence suggests that the Envi™-SR Thrombectomy Device is effective for ischemic stroke?

Research has shown that using a stent-retriever, such as the Envi™-SR device, leads to better outcomes for stroke patients compared to medication alone. The Envi™-SR is a new tool designed to remove blood clots in stroke patients. Early studies suggest it effectively clears blocked blood vessels. In this trial, participants will receive either the Envi™-SR Thrombectomy Device or the Solitaire or Trevo Revascularization Device. While researchers collect more data, the Envi™-SR aims to improve recovery chances for stroke patients. Overall, devices like this have shown promise in treating strokes. ^{1 2 3 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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]

Citations

1. evtoday.com evtoday.com/news/neurovascs-envi-sr-mechanical-thrombectomy-system-studied-in-china

NeuroVasc's Envi-SR Mechanical Thrombectomy System ... The Envi-SR system is a third-generation stent retriever for the removal of blood clots in patients with acute ischemic stroke caused by large vessel occlusion.

2. withpower.com withpower.com/trial/envi-sr-thrombectomy-device-for-ischemic-stroke-a0adb

Envi™-SR Thrombectomy Device for Ischemic Stroke The study objective is to examine and compare clinical outcomes, as measured by Modified Rankin Scale (mRS) at 90 days (± 15 days) post treatment, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10402757/

MASTRO I: Meta-Analysis and Systematic Review ... Stent-retriever (SR) thrombectomy has demonstrated superior outcomes in patients with acute ischemic stroke compared with medical management ...

4. neuronewsinternational.com neuronewsinternational.com/neurovasc-announces-enrolment-of-first-patient-in-envi-sr-mechanical-thrombectomy-system-clinical-trial/

NeuroVasc announces enrolment of first patient in ENVI- ... The study is a prospective, multicentre RCT to evaluate the safety and efficacy of NeuroVasc's mechanical thrombectomy system for the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05107206

Study Details | NCT05107206 | Envi™-SR Randomized ... The study objective is to examine and compare clinical outcomes, as measured by Modified Rankin Scale (mRS) at 90 days (± 15 days) post treatment, ...

6. neurovasctechnologies.com neurovasctechnologies.com/envi-sr

eNVi™-SR Powered by a unique segmental design, our next generation NeuroVasc eNVi™-SR is designed to remain open under tension when retracting through tortuosity and ...