Endovascular Reperfusion for Stroke

(PERFUSION AIS Trial)

Overseen By Kristen Hlozek, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Euphrates Vascular, Inc.

Must not be taking: Anticoagulants, Dual antiplatelets

Disqualifiers: Pregnancy, Renal failure, Hemorrhage, others

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

Compensation: Varies

Number of Visits: 5

Duration: Immediate

8 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking Coumadin, its interruption could compromise your safety, and you should discuss this with the trial team.

What data supports the effectiveness of the treatment Pulse NanoMED System, Pulse NanoMED System, Pulse Endovascular ReperFUSION for stroke?

Research shows that newer endovascular devices, like those used in the Pulse NanoMED System, have improved outcomes in stroke patients by restoring blood flow more effectively than older methods. Studies have demonstrated that these devices can lead to better recovery in patients with certain types of artery blockages, especially when used soon after stroke symptoms begin. ^{1 2 3 4 5}

How is the Pulse NanoMED System treatment different from other stroke treatments?

The Pulse NanoMED System is unique because it is an endovascular treatment, meaning it is performed inside the blood vessels, and it uses mechanical devices to quickly remove clots, potentially offering faster and more effective treatment for large-vessel blockages compared to traditional drug-based therapies. ^{1 2 6 7 8}

What is the purpose of this trial?

Prospective, multi-center, single-arm early feasibility study enrolling a minimum of 15 subjects at up to a minimum of 3 active investigational sites in the United States. The subjects must be diagnosed with acute ischemic stroke (AIS), must be post-mechanical thrombectomy, will have had intravenous thrombolytics, and have a visible MCA, ACA or PCA occlusive clot on initial angiographic imaging. Each subject will receive the Pulse NanoMED procedure after attempted neurovascular therapy to achieve better reperfusion.

Eligibility Criteria

This trial is for adults aged 18-85 who've had a stroke caused by a clot in major brain arteries and have already undergone mechanical thrombectomy. They must be within 9 hours of their last known well time, not severely disabled before the stroke, with certain scores on neurological and imaging assessments. Pregnant women, those with severe allergies to iron or contrast materials, serious coagulation disorders, uncontrolled high blood pressure, advanced terminal illnesses or conditions that interfere with the study can't participate.

Inclusion Criteria

Your initial NIH Stroke Scale score is 6 or higher.

The participant provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) or an acceptable patient surrogate.

Your CT scan without contrast shows a score higher than 6 if your symptoms have been present for less than 8 hours.

Exclusion Criteria

You have a low platelet count, less than 100,000.

Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol.

Current participation in another investigational drug or device treatment study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Pulse NanoMED procedure after attempted neurovascular therapy to achieve better reperfusion

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

4 visits (in-person) at 24 hours, 7 days, 30 days, and 90 days post-procedure

Treatment Details

Interventions

• Pulse NanoMED System

Trial Overview The Pulse NanoMED System is being tested in this early feasibility study to see if it can improve blood flow after standard treatment for acute ischemic stroke has left some blockage. Participants will receive this procedure at select U.S. centers following initial therapy like mechanical thrombectomy.

Participant Groups

Group I: Group/Cohort Experimental Treatment 1 Intervention

Subjects presenting to the emergency department with AIS, eligible for thrombolytic therapy, and with evidence of an occlusive clot by angiographic imaging will be considered for inclusion in the study. Post-thrombolytic therapy and mechanical thrombectomy eligible Subjects will receive the experimental NanoMED device.

Who Is Running the Clinical Trial?

Euphrates Vascular, Inc.

Lead Sponsor

Trials

2

Recruited

40+

Findings from Research

Mechanical neurothrombectomy devices provide a promising alternative to the standard intravenous tissue plasminogen activator for treating acute ischemic stroke, as they can achieve faster recanalization and are particularly effective for large-vessel occlusions.

These devices may also carry a lower risk of hemorrhagic complications compared to traditional pharmacologic treatments, making them a safer option for patients experiencing stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State-of-the-art endovascular treatment of acute ischemic stroke. Raphaeli, G., Mazighi, M., Pereira, VM., et al.[2022]

Reperfusion therapies, including intravenous thrombolysis and endovascular procedures, are effective in reducing disability during acute stroke by restoring blood flow.

There are currently four FDA-cleared devices for treating arterial occlusions in ischemic stroke, and advancements in imaging and device technology are expected to enhance recanalization success and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reperfusion therapy in the acute management of ischemic stroke. Lin, MP., Sanossian, N.[2014]

Recent pivotal trials (2015) demonstrated that newer-generation endovascular thrombectomy devices significantly improve functional outcomes for stroke patients with specific artery occlusions when performed within 6 hours of symptom onset.

Further studies (2018) confirmed the efficacy of thrombectomy for late-presenting patients and those with a mismatch between neurological severity and ischemic core volume, expanding treatment eligibility to up to 24 hours after onset.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evidence and Patient Selection for Endovascular Reperfusion Therapy for Acute Ischemic Stroke:A Narrative Review]. Hayakawa, M.[2023]

Mechanical clot retrievers have significantly improved outcomes for patients with large cerebral artery occlusions who are either ineligible for or have failed treatment with intravenous recombinant tissue plasminogen activator.

There is a critical need for stroke neurologists to develop neuroendovascular therapy skills, highlighting the importance of establishing educational systems to train them effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Education for stroke neurologists in neuroendovascular revascularization therapy of acute ischemic stroke]. Takada, T.[2015]

Endovascular reperfusion therapy is a promising treatment for acute ischemic stroke, requiring careful patient selection and evaluation of occlusion for effective management.

Intra-arterial chemical thrombolysis using agents like alteplase has shown positive results, while mechanical thrombolysis is emerging as a complementary treatment, with ongoing trials assessing the safety and efficacy of these approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroendovascular management of acute ischemic stroke. Tjoumakaris, SI., Jabbour, PM., Rosenwasser, RH.[2009]

The novel cerebral embolic protection device was successfully deployed in 4 patients (average age 90) undergoing aortic valve procedures, with no complications reported during the procedures.

Cerebral imaging post-procedure showed no new defects in most patients, suggesting that the device may effectively reduce the risk of cerebral embolism and stroke during these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An embolic deflection device for aortic valve interventions. Nietlispach, F., Wijesinghe, N., Gurvitch, R., et al.[2014]

The Penumbra system, originally designed for stroke treatment, has been successfully adapted for use in treating acute distal embolism in the foot arteries during revascularization procedures, demonstrating its versatility.

In a small study involving three diabetic patients, the device effectively restored blood flow in occluded arteries without complications, suggesting it could be a rapid and effective solution for preventing serious complications from foot embolization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foot Embolization During Limb Salvage Procedures in Critical Limb Ischemia Patients Successfully Managed With Mechanical Thromboaspiration: A Technical Note. Gandini, R., Merolla, S., Chegai, F., et al.[2015]

The Penumbra 054 Reperfusion Catheter System demonstrated a high revascularization rate of 91% in patients with large vessel occlusions, significantly higher than the 82% rate reported in the previous Penumbra Pivotal trial, and achieved this in a median time of just 20 minutes compared to 45 minutes in the earlier study.

At 90-day follow-up, 34.9% of patients had a good neurologic outcome, which is an improvement over the 25% seen in the Penumbra Pivotal trial, indicating that faster and more effective revascularization may lead to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SPEED study: initial clinical evaluation of the Penumbra novel 054 Reperfusion Catheter. Frei, D., Gerber, J., Turk, A., et al.[2013]

References

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

State-of-the-art endovascular treatment of acute ischemic stroke. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Reperfusion therapy in the acute management of ischemic stroke. [2014]

3. Japan pubmed.ncbi.nlm.nih.gov

[Evidence and Patient Selection for Endovascular Reperfusion Therapy for Acute Ischemic Stroke:A Narrative Review]. [2023]

4. Japan pubmed.ncbi.nlm.nih.gov

[Education for stroke neurologists in neuroendovascular revascularization therapy of acute ischemic stroke]. [2015]

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

Neuroendovascular management of acute ischemic stroke. [2009]

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

An embolic deflection device for aortic valve interventions. [2014]

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

Foot Embolization During Limb Salvage Procedures in Critical Limb Ischemia Patients Successfully Managed With Mechanical Thromboaspiration: A Technical Note. [2015]

8. England pubmed.ncbi.nlm.nih.gov

The SPEED study: initial clinical evaluation of the Penumbra novel 054 Reperfusion Catheter. [2013]