Endovascular Reperfusion for Stroke
(PERFUSION AIS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Euphrates Vascular, Inc.
Must not be taking: Anticoagulants, Dual antiplatelets
Disqualifiers: Pregnancy, Renal failure, Hemorrhage, others
No Placebo Group
Trial Summary
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.
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.
12345How 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.
12678Eligibility 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
I am between 18 and 85 years old.
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.
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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
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Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Group/CohortExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of South Carolina - PrismaColumbia, SC
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Who Is Running the Clinical Trial?
Euphrates Vascular, Inc.Lead Sponsor
References
State-of-the-art endovascular treatment of acute ischemic stroke. [2022]Stroke is the third leading cause of death in the USA. An estimated 795,000 new or recurrent stroke events occur annually, mostly ischemic in nature. Arterial recanalization and subsequent reperfusion performed shortly after symptom onset can help to restore brain function in acute ischemic stroke (AIS). The only treatment currently approved by the United States Food and Drug Administration is intravenous tissue plasminogen activator, administered within 4.5 h of symptom onset. However, this short window often precludes effective intervention. Mechanical neurothrombectomy devices offer many potential advantages over pharmacologic thrombolysis, including more rapid achievement of recanalization, enhanced efficacy in treating large-vessel occlusions, and a potentially lower risk of hemorrhagic events. The goal of this chapter is to describe the state-of-the-art neurothrombectomy devices and stenting techniques for endovascular treatment of acute ischemic stroke, as well as to highlight recent advances in reperfusion therapies. Ongoing clinical trials, some with randomized, controlled designs, are included.
Reperfusion therapy in the acute management of ischemic stroke. [2014]Reperfusion, or restoration of blood flow, is an effective means of reducing disability in the setting of acute stroke. Reperfusion therapies, such as intravenous thrombolysis or endovascular and interventional procedures, fit within the existing stroke system of care. There are currently 4 devices cleared by the Food and Drug Administration for recanalization of arterial occlusion in patients with ischemic stroke. Endovascular device technology and advanced imaging technology continue to evolve with newer devices suggesting greater recanalization success. A new paradigm using advanced imaging to select patients in combination with newer devices is being tested and may lead to great improvements in care.
[Evidence and Patient Selection for Endovascular Reperfusion Therapy for Acute Ischemic Stroke:A Narrative Review]. [2023]Three former stroke trials failed to show the efficacy of endovascular stroke reperfusion therapy using intra-arterial thrombolysis or older-generation mechanical thrombectomy devices, compared with usual medical care in 2013. However, five pivotal trials in 2015(MR CLEAN, ESCAPE, EXTEND-IA, SWIFT PRIME, and REVASCAT), using newer-generation devices(e.g., stent retrievers), have shown stroke thrombectomy to clearly improve the functional outcome of patients with occlusion of the internal carotid artery or the M1 portion of the middle cerebral artery(baseline National Institutes of Health Stroke Scale score ≥ 6; baseline Alberta Stroke Program Early Computed Tomography Score ≥ 6), and who could receive thrombectomy within 6 h of symptom onset . In 2018, the efficacy of stroke thrombectomy for late-presenting patients with up to 16-24 h of onset and those who had a mismatch between neurological severity and ischemic core volume was also established by the DAWN and DEFUSE 3 trials. In 2022, the efficacies of stroke thrombectomy for patients with a large ischemic core or basilar artery occlusion were identified. This article discusses the evidence and patient selection for endovascular reperfusion therapy for acute ischemic stroke.
[Education for stroke neurologists in neuroendovascular revascularization therapy of acute ischemic stroke]. [2015]Outcome of large cerebral artery occlusions in intravenous recombinant tissue plasminogen activator failed and ineligible patients has been improved by Mechanical clot retrievers. The key words of revascularization therapies are improvement of reperfusion rate and shortening of reperfusion time. Stroke neurologists have to acquire skill of neuroendovascular therapy technique, because acute stroke patients are examined first by stroke neurologists. However acquisition of neuroendovascular skills are not easy for stroke neurologists. It is important that we establish the educational systems of neuroendovascular therapy for stroke neurologists.
Neuroendovascular management of acute ischemic stroke. [2009]Endovascular reperfusion therapy is evolving as a promising treatment in the setting of acute ischemic stroke. Careful patient selection and angiographic evaluation of the location and extent of occlusion are necessary for the successful management of stroke patients. Intra-arterial chemical thrombolysis, with such agents as alteplase and urokinase, has shown favorable results in the early management of cerebrovascular ischemia. Mechanical thrombolysis is becoming an adjunctive or alternative treatment therapy via novel clot dissolution and retrieval techniques. Existing and upcoming trials are investigating the safety and efficacy of neuroendovascular therapy while attempting to expand its indications in acute ischemic stroke.
An embolic deflection device for aortic valve interventions. [2014]We describe initial human experience with a novel cerebral embolic protection device.
Foot Embolization During Limb Salvage Procedures in Critical Limb Ischemia Patients Successfully Managed With Mechanical Thromboaspiration: A Technical Note. [2015]To illustrate the use of a mechanical thromboaspiration device originally designed for clot retrieval in acute stroke in the treatment of acute distal embolism occurring during percutaneous revascularization of the femoropopliteal and below-the-knee arterial segments.
The SPEED study: initial clinical evaluation of the Penumbra novel 054 Reperfusion Catheter. [2013]Revascularization of acute ischemic stroke from a large vessel occlusion continues to be a challenge with current thrombectomy devices. The purpose of the SPEED study was to report the safety and effectiveness of the Penumbra 054 Reperfusion Catheter System in revascularizing large vessel occlusions.