pRESET for Occlusive Stroke Treatment

Completed · Not applicable

Conditions studied: Brain Diseases, Cardiovascular Diseases, Central Nervous System Diseases, Cerebrovascular Disorders, Ischemia, Nervous System Diseases, Pathologic Processes, Stroke, Ischemic, Stroke, Acute, Vascular Diseases

In brief

Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion

Key facts

Study ID

NCT03994822

Run by

phenox Inc.

People needed

340

Starts

2019-10-04

Expected to finish

2022-05-12

Last updated by the study team

2023-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >/=18
• Clinical signs consistent with acute ischemic stroke
• Subject is able to be treated within 8 hours of stroke symptom onset and within 1.5 hours (90 min) from screening CT / MRI to groin puncture.
• Pre-stroke modified Rankin Score of 0 or 1
• NIHSS ≥6 at the time of enrolment
• If tPA is indicated, initiation of IV tPA should be administered as soon as possible and no later than 3.0 hours of onset of stroke symptoms (onset time is defined as the last time when the patient was witnessed to be at baseline neurologic status), with investigator verification that the subject has received/is receiving the correct IV tPA dose (0.9mg/kg) for the estimated weight.
• Expanded Thrombolysis in Cerebral Infarction (eTICI) 0-1 flow confirmed by angiography that is accessible to the mechanical thrombectomy device in the following locations:
• Intracranial internal carotid
• M1 and/or M2 segment of the MCA
• Carotid terminus
• Vertebral artery
• Basilar artery
• Note: M1 segment of the MCA is defined as the arterial trunk from its origin at the ICA to the first bifurcation or trifurcation into major branches neglecting the small temporo-polar branch.
• Imaging scores as follows:
• · ASPECTS score must be 6-10 on NCCT or DWI-MRI.
• If automated core volume assessment software is used:
• MR diffusion-weighted imaging (DWI) ≤50cc
• Computed tomography perfusion (CTP) core ≤50 cc
• Subject is willing to conduct protocol-required follow-up visits.
• A valid completed informed consent by participant or LAR (Legally Authorized Representative)

You may not qualify if…

• Subject who has received IA-tPA prior to enrolment in the study
• Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
• Rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke
• Known serious sensitivity to radiographic contrast agents
• Known sensitivity to nickel, titanium metals, or their alloys
• Subjects already enrolled in other investigational studies that would interfere with study endpoints
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. (A subject without history or suspicion of coagulopathy does not require INR or prothrombin time lab results to be available prior to enrolment.)
• Known renal failure as defined by a serum creatinine > 2.0 mg/dl (or 176.8 μmol/l) or glomerular filtration rate (GFR) < 30.
• Subject who requires hemodialysis or peritoneal dialysis, or who has a contraindication to an angiogram for whatever reason.
• Life expectancy of less than 90 days
• Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
• Suspicion of aortic dissection
• Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
• Subject is known to currently use or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
• Known arterial condition (e.g., proximal vessel stenosis or pre-existing stent) that would prevent the device from reaching the target vessel and/or preclude safe recovery of the device
• Subject who requires balloon angioplasty or stenting of the carotid artery at the time of the index procedure
• Angiographic evidence of carotid dissection
• Imaging exclusion criteria:
• CT or MRI evidence of hemorrhage on presentation
• CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma)
• CT or MRI evidence of cerebral vasculitis
• CT or MRI-DWI showing ASPECTS 0-5. Alternatively, if automated core volume assessment software is used, MRI-DWI or CTP core > 50cc.
• CT/MRI shows evidence of carotid dissection or complete cervical carotid occlusion requiring a stent
• Any imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc.).
• Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) as confirmed by angiography, or clinical evidence of bilateral strokes or strokes in multiple territories

Where it is running

• Honor Health Research Institute — Scottsdale, Arizona, United States
• Providence Little Company of Mary Medical Center — Santa Monica, California, United States
• University of Miami — Coral Gables, Florida, United States
• Baptist Health Research Institute Jacksonville — Jacksonville, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Advocate Lutheran General Hospital — Downers Grove, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• JFK Medical Center — Edison, New Jersey, United States
• Buffalo General Medical Center — Buffalo, New York, United States
• NYU Langone Health — New York, New York, United States
• The Mount Sinai Hosptial — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• OhioHealth Research Institute — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Valley Baptist — Harlingen, Texas, United States
• Swedish Medical Center - Cherry Hill Campus — Seattle, Washington, United States
• Universitätsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany
• Klinikum rechts der Isar Technische Universität München — München, Bavaria, Germany
• Klinikum Bremen-Mitte — Bremen, Lower Saxony, Germany
• Universitätsklinikum Schleswig-Holstein, Campus Lübeck — Lübeck, Schleswig-Holstein, Germany
• Helios Klinikum Erfurt GmbH — Erfurt, Thuringia, Germany

Full record on ClinicalTrials.gov

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