Brain Diseases, Cardiovascular Diseases, Central Nervous System Diseases, Cerebrovascular Disorders, Ischemia, Nervous System Diseases, Pathologic Processes, Stroke, Acute, Stroke, Ischemic, Vascular Diseases
Conditions
Keywords
Brain, Brain Clot, Brain Infarction, Cerebral Ischemia, Cerebrovascular Disorders, Ischemia, Ischemic, Ischemic Stroke, Mechanical Thrombectomy, Neurovascular Intervention, phenox, pRESET, pRESET Thrombectomy Device, Revascularization, Randomized Control, Solitaire, Stent Retriever, Stroke, Vascular Diseases
Brief summary
Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion
Detailed description
To determine the safety and effectiveness of pRESET for the treatment of acute ischemic stroke within 8 hours of symptom onset (defined as time patient was last seen well) due to large vessel occlusion and to compare safety and effectiveness to the predicate device, Solitaire™ Platinum revascularization device
Interventions
DEVICEMechanical Thrombectomy using the pRESET Thrombectomy device
Clot removal using the pRESET Thrombectomy device
DEVICEMechanical Thrombectomy using the Solitaire Revascularization Device
Clot removal using the Solitaire Revascularization Device
Sponsors
phenox Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The blinded assessor performs all study assessments during and after hospital discharge (i.e., 24 hours, Day 7/Discharge (whichever is earlier), and 30 and day 90 visits
Intervention model description
Prospective, multi-center randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>/=18 2. Clinical signs consistent with acute ischemic stroke 3. 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. 4. Pre-stroke modified Rankin Score of 0 or 1 5. NIHSS ≥6 at the time of enrolment 6. 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. 7. Expanded Thrombolysis in Cerebral Infarction (eTICI) 0-1 flow confirmed by angiography that is accessible to the mechanical thrombectomy device in the following locations: 1. Intracranial internal carotid 2. M1 and/or M2 segment of the MCA 3. Carotid terminus 4. Vertebral artery 5. 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. 8. 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 9. Subject is willing to conduct protocol-required follow-up visits. 10. A valid completed informed consent by participant or LAR (Legally Authorized Representative)
Exclusion criteria
1. Subject who has received IA-tPA prior to enrolment in the study 2. Female who is pregnant or lactating or has a positive pregnancy test at time of admission. 3. Rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke 4. Known serious sensitivity to radiographic contrast agents 5. Known sensitivity to nickel, titanium metals, or their alloys 6. Subjects already enrolled in other investigational studies that would interfere with study endpoints 7. 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.) 8. Known renal failure as defined by a serum creatinine \> 2.0 mg/dl (or 176.8 μmol/l) or glomerular filtration rate (GFR) \< 30. 9. Subject who requires hemodialysis or peritoneal dialysis, or who has a contraindication to an angiogram for whatever reason. 10. Life expectancy of less than 90 days 11. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal 12. Suspicion of aortic dissection 13. 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. 14. 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). 15. 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 16. Subject who requires balloon angioplasty or stenting of the carotid artery at the time of the index procedure 17. Angiographic evidence of carotid dissection Imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint: Patients with a Modified Rankin Scale (mRS) </= 2 | 90 (+/-15) days | Global disability assessed via the blinded evaluation of the proportion of patients with a Modified Rankin Scale (mRS) \</= 2 |
| Primary Safety Endpoint: Device- or procedure-related symptomatic intracerebral hemorrhage (sICH) | 24 (-8/+12) hours | Proportion of subjects with device- or procedure-related symptomatic intracerebral hemorrhage (sICH) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Revascularization measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI) | During Index Procedure | Proportion of subjects with eTICI 2b50 or greater flow in the target vessel post procedure with 3 or fewer passes of the assigned study device. |
| Successful Revascularization on first pass measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI) | During Index Procedure | Proportion of patients with eTICI 2c or greater, following the first pass of the assigned study device |
| Overall mortality following the index stroke | 90 (+/-15) days | Overall mortality following the index stroke |
| Distribution of mRS shift across the entire spectrum of disability | 90 (+/-15) days | Distribution of mRS shift across the entire spectrum of disability |
Countries
Germany, United States
Outcome results
None listed