Clinical trial NCT03994822: pRESET for Occlusive Stroke Treatment
Official title: pRESET for Occlusive Stroke Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Ischemia
Nervous System Diseases
Pathologic Processes
Stroke, Ischemic
Stroke, Acute
Vascular Diseases
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
Lead sponsor: phenox Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-21
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multi-center randomized
Primary purpose: TREATMENT

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

Eligibility criteria: 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 exclusion criteria:
18. CT or MRI evidence of hemorrhage on presentation
19. CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma)
20. CT or MRI evidence of cerebral vasculitis
21. CT or MRI-DWI showing ASPECTS 0-5. Alternatively, if automated core volume assessment software is used, MRI-DWI or CTP core \> 50cc.
22. CT/MRI shows evidence of carotid dissection or complete cervical carotid occlusion requiring a stent
23. 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.).
24. 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

Primary outcomes:
measure: Primary Effectiveness Endpoint: Patients with a Modified Rankin Scale (mRS) </= 2
timeFrame: 90 (+/-15) days
measure: Primary Safety Endpoint: Device- or procedure-related symptomatic intracerebral hemorrhage (sICH)
timeFrame: 24 (-8/+12) hours
Secondary outcomes:
measure: Successful Revascularization measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)
timeFrame: During Index Procedure
measure: Successful Revascularization on first pass measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)
timeFrame: During Index Procedure
measure: Overall mortality following the index stroke
timeFrame: 90 (+/-15) days
measure: Distribution of mRS shift across the entire spectrum of disability
timeFrame: 90 (+/-15) days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health Research Institute
state: Arizona
city: Santa Monica
country: United States
facility: Providence Little Company of Mary Medical Center
state: California
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health Research Institute Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Downers Grove
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Edison
country: United States
facility: JFK Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: The Mount Sinai Hosptial
state: New York
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Harlingen
country: United States
facility: Valley Baptist
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center - Cherry Hill Campus
state: Washington
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: München
country: Germany
facility: Klinikum rechts der Isar Technische Universität München
state: Bavaria
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte
state: Lower Saxony
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
state: Schleswig-Holstein
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt GmbH
state: Thuringia
Study officials:
affiliation: University of Pittsburgh Medical Center, Pittsburgh
name: Raul G Nogueira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Medical Center Jacksonville
name: Richardo A Hanel, MD
role: PRINCIPAL_INVESTIGATOR
References: