Clinical Trial TitleThis research study is to compare the safety and effectiveness of the pRESET investigational device to the Solitaire FDA approved device in patients with acute ischemic stroke due to large vessel occlusion.
National Clinical Trial Number:NCT03994822
Clinical Trial Protocol Description:
If it is confirmed that you have a stroke and choose to participate you will be randomized, like the flip of a coin, to a mechanical thrombectomy (clot retrieval) using either the pRESET investigational device, or Solitaire approved device. You will have tests, exams and procedures that are part of your standard care and for study purposes. The total amount of time you will be in this study is 90 days.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age.
- Have clinical signs consistent with acute ischemic stroke.
- Are 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.
- Have a pre-stroke modified Rankin Score of 0 or 1.
- Have a 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.
- Have 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.
- Have 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
- Are willing to conduct protocol-required follow-up visits.
- Have a valid signed and dated informed consent by participant or LAR (Legally Authorized Representative) has been obtained.
- Note: If approved by the local Ethics Committee and country regulations, an independent physician is permitted to sign consent, to allow enrolment in the study. However, as soon as possible, the patient is informed and his/her consent is requested for the possible continuation of this research.
You will be excluded from the study if any of the following criteria apply to you:
- Has received IA-tPA prior to enrolment in the study.
- Are a female who is pregnant or lactating or has a positive pregnancy test at time of admission.
- Have rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke
- Have known serious sensitivity to radiographic contrast agents.
- Have known sensitivity to nickel, titanium metals, or their alloys.
- Are already enrolled in other investigational studies that would interfere with study endpoints.
- Have 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.)
- Have known renal failure as defined by a serum creatinine > 2.0 mg/dl (or 176.8 μmol/l) or glomerular filtration rate (GFR) < 30.
- Require hemodialysis or peritoneal dialysis, or have a contraindication to an angiogram for whatever reason.
- Have a life expectancy of less than 90 days.
- Have clinical presentation that suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.
- Have suspicion of aortic dissection.
- Have a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
- Are known to currently use or have a recent history of illicit drug(s) or abuse alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
- Have 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.
- Require balloon angioplasty or stenting of the carotid artery at the time of the index procedure.
- Have angiographic evidence of carotid dissection.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.