Envi™-SR Thrombectomy Device for Ischemic Stroke

(ENVI RCT Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Raul G Nogueira, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NeuroVasc Technologies

Must be taking: IV t-PA

Must not be taking: Illicit drugs

Disqualifiers: Pregnancy, Renal failure, Hypertension, others

No Placebo Group

Approved in 3 Jurisdictions

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}

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.

Trial 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)

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Baptist Health Research Institute Jacksonville, FL

North Shore University Hospital Manhasset, NY

Advocate Aurora Health Downers Grove, IL

Providence Medical Foundation Irvine, CA

Who Is Running the Clinical Trial?

NeuroVasc Technologies Lead Sponsor

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] Thrombectomy with aspiration catheters has shown to be effective for treatment of intracranial large vessel occlusion (LVO). We present preclinical evaluation of the safety and efficacy of React68 and React71 (Medtronic PLC, Irvine, CA) catheters in animal models of LVO.

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] The NeVa™ thrombectomy device (Vesalio LLC, Nashville, USA) has been reported to succeed in large vessel occlusion thrombectomy in animal, in-vitro, and clinical studies. Designed with Drop Zone technology, a closed distal tip, and strong expansive radial force, the device demonstrated particular efficiency in resistant "white" thrombi in preclinical research. Our goal is to determine the safety and performance of this novel stent retriever on first-pass rates and overall recanalization.

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

Neurothrombectomy for the treatment of acute ischemic stroke: results from the TREVO study. [2022] Fast recanalization has been shown to be one of the most important factors for good clinical outcome in stroke patients with acute large vessel occlusion. While intravenous thrombolysis has been shown to be of limited effect in patients with large clot burden, intra-arterial neurothrombectomy offers a new and promising possibility to achieve high recanalization rates within a short time. The Trevo device is a stent-like retriever and was primarily designed to remove thrombus in patients experiencing an acute ischemic stroke. We report on the results of the TREVO Study, which was a prospective, multicenter study in acute stroke patients treated with the Trevo device.

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

First pass results of mechanical thrombectomy with two-drop zone NeVaTM device. [2022] Label="BACKGROUND" NlmCategory="BACKGROUND">Occlusive thrombi in acute ischemic stroke can be in various types which limits the success of the thrombectomy. The NeVaTM (Vesalio, Nashville, Tennessee) thrombectomy device was originally designed for all types of clot. Our aim was to evaluate the efficacy and safety of the NeVaTM device for mechanical thrombectomy.

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] Different feasible and safe thrombectomy and distal protection devices have been used in clinical practice. The efficiency and safety of adjunct thrombectomy using Diver CE device (Invatec, Italy) versus Guardwire Plus device (Medtronic, USA) before percutaneous coronary intervention (PCI) were compared in patients with acute inferior ST-segment-elevation myocardial infarction (STEMI) for less than 12 hours, thrombolysis in myocardial infarction (TIMI) flow grade 0 to 1, and total occlusion of the proximal right coronary artery (= 3 mm in diameter) in a prospective randomized single-center study.

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

Novel and emerging technologies for endovascular thrombectomy. [2017] Endovascular thrombectomy device improvements in recent years have served a pivotal role in improving the success and safety of the thrombectomy procedure. As the intervention gains widespread use, developers have focused on maximizing the reperfusion rates and reducing procedural complications associated with these devices. This has led to a boom in device development. This review will cover novel and emerging technologies developed for endovascular thrombectomy.

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] The NeVa™ (Vesalio, Nashville, Tennessee) thrombectomy device is a CE-approved novel hybrid-cell stent retriever with offset enlarged openings coupled with functional zones and a closed distal end. The device was designed to incorporate and trap resistant emboli. The purpose was to determine the safety and efficacy of the NeVa™ stent.