PROST: pRESET for Occlusive Stroke Treatment
Study Details
Study Description
Brief Summary
Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: pRESET Thrombectomy Device Mechanical Thrombectomy using the pRESET Thrombectomy Device |
Device: Mechanical Thrombectomy using the pRESET Thrombectomy device
Clot removal using the pRESET Thrombectomy device
|
Active Comparator: Solitaire Revascularization Device Mechanical Thrombectomy using the Solitaire Revascularization Device |
Device: Mechanical Thrombectomy using the Solitaire Revascularization Device
Clot removal using the Solitaire Revascularization Device
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age >/=18
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Clinical signs consistent with acute ischemic stroke
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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.
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Pre-stroke modified Rankin Score of 0 or 1
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NIHSS ≥6 at the time of enrolment
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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.
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Expanded Thrombolysis in Cerebral Infarction (eTICI) 0-1 flow confirmed by angiography that is accessible to the mechanical thrombectomy device in the following locations:
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Intracranial internal carotid
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M1 and/or M2 segment of the MCA
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Carotid terminus
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Vertebral artery
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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:
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MR diffusion-weighted imaging (DWI) ≤50cc
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Computed tomography perfusion (CTP) core ≤50 cc
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Subject is willing to conduct protocol-required follow-up visits.
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A valid completed informed consent by participant or LAR (Legally Authorized Representative)
Exclusion Criteria:
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Subject who has received IA-tPA prior to enrolment in the study
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Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
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Rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke
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Known serious sensitivity to radiographic contrast agents
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Known sensitivity to nickel, titanium metals, or their alloys
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Subjects already enrolled in other investigational studies that would interfere with study endpoints
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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.)
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Known renal failure as defined by a serum creatinine > 2.0 mg/dl (or 176.8 μmol/l) or glomerular filtration rate (GFR) < 30.
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Subject who requires hemodialysis or peritoneal dialysis, or who has a contraindication to an angiogram for whatever reason.
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Life expectancy of less than 90 days
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Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
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Suspicion of aortic dissection
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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.
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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).
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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
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Subject who requires balloon angioplasty or stenting of the carotid artery at the time of the index procedure
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Angiographic evidence of carotid dissection
Imaging exclusion criteria:
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CT or MRI evidence of hemorrhage on presentation
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CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma)
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CT or MRI evidence of cerebral vasculitis
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CT or MRI-DWI showing ASPECTS 0-5. Alternatively, if automated core volume assessment software is used, MRI-DWI or CTP core > 50cc.
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CT/MRI shows evidence of carotid dissection or complete cervical carotid occlusion requiring a stent
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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.).
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Honor Health Research Institute | Scottsdale | Arizona | United States | 85251 |
2 | Providence Little Company of Mary Medical Center | Santa Monica | California | United States | 90404 |
3 | University of Miami | Coral Gables | Florida | United States | 33146 |
4 | Baptist Health Research Institute Jacksonville | Jacksonville | Florida | United States | 32207 |
5 | Grady Memorial Hospital | Atlanta | Georgia | United States | 30322 |
6 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
7 | Advocate Lutheran General Hospital | Downers Grove | Illinois | United States | 60515 |
8 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
9 | University of Massachusetts | Worcester | Massachusetts | United States | 01655 |
10 | JFK Medical Center | Edison | New Jersey | United States | 08820 |
11 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
12 | Buffalo General Medical Center | Buffalo | New York | United States | 14203 |
13 | NYU Langone Health | New York | New York | United States | 10016 |
14 | The Mount Sinai Hosptial | New York | New York | United States | 10029 |
15 | OhioHealth Research Institute | Columbus | Ohio | United States | 43214 |
16 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
17 | UPMC | Pittsburgh | Pennsylvania | United States | 15213 |
18 | Valley Baptist | Harlingen | Texas | United States | 78550 |
19 | Swedish Medical Center - Cherry Hill Campus | Seattle | Washington | United States | 98122 |
20 | Universitätsklinikum Heidelberg | Heidelberg | Baden-Württemberg | Germany | 69120 |
21 | Klinikum rechts der Isar Technische Universität München | München | Bavaria | Germany | 81675 |
22 | Klinikum Bremen-Mitte | Bremen | Lower Saxony | Germany | 28205 |
23 | Universitätsklinikum Schleswig-Holstein, Campus Lübeck | Lübeck | Schleswig-Holstein | Germany | 23562 |
24 | Helios Klinikum Erfurt GmbH | Erfurt | Thuringia | Germany | 99089 |
Sponsors and Collaborators
- phenox Inc.
Investigators
- Principal Investigator: Raul G Nogueira, MD, Grady Memorial Hospital
- Principal Investigator: Richardo A Hanel, MD, Baptist Medical Center Jacksonville
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- pCT-001-19