pRESET for Occlusive Stroke Treatment (PROST)

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

Study Overview

• Status: Completed
• Conditions: Ischemia; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke, Ischemic; Stroke, Acute
• Intervention / Treatment: Device: Mechanical Thrombectomy using the pRESET Thrombectomy device; Device: Mechanical Thrombectomy using the Solitaire Revascularization Device

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 Type: Interventional
• Enrollment (Actual): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Universitätsklinikum Heidelberg
  • Bavaria
    • München, Bavaria, Germany, 81675
      • Klinikum rechts der Isar Technische Universität München
  • Lower Saxony
    • Bremen, Lower Saxony, Germany, 28205
      • Klinikum Bremen-Mitte
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23562
      • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Thuringia
    • Erfurt, Thuringia, Germany, 99089
      • Helios Klinikum Erfurt GmbH
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Honor Health Research Institute
  • California
    • Santa Monica, California, United States, 90404
      • Providence Little Company of Mary Medical Center
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami
    • Jacksonville, Florida, United States, 32207
      • Baptist Health Research Institute Jacksonville
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Grady Memorial Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Downers Grove, Illinois, United States, 60515
      • Advocate Lutheran General Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • New Jersey
    • Edison, New Jersey, United States, 08820
      • JFK Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Buffalo, New York, United States, 14203
      • Buffalo General Medical Center
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10029
      • The Mount Sinai Hosptial
  • Ohio
    • Columbus, Ohio, United States, 43214
      • OhioHealth Research Institute
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC
  • Texas
    • Harlingen, Texas, United States, 78550
      • Valley Baptist
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center - Cherry Hill Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint: Patients with a Modified Rankin Scale (mRS) </= 2	Global disability assessed via the blinded evaluation of the proportion of patients with a Modified Rankin Scale (mRS) </= 2	90 (+/-15) days
Primary Safety Endpoint: Device- or procedure-related symptomatic intracerebral hemorrhage (sICH)	Proportion of subjects with device- or procedure-related symptomatic intracerebral hemorrhage (sICH)	24 (-8/+12) hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Revascularization measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)	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.	During Index Procedure
Successful Revascularization on first pass measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)	Proportion of patients with eTICI 2c or greater, following the first pass of the assigned study device	During Index Procedure
Overall mortality following the index stroke	Overall mortality following the index stroke	90 (+/-15) days
Distribution of mRS shift across the entire spectrum of disability	Distribution of mRS shift across the entire spectrum of disability	90 (+/-15) days

Collaborators and Investigators

• Sponsor: phenox Inc.
• Investigators: Principal Investigator: Richardo A Hanel, MD, Baptist Medical Center Jacksonville; Principal Investigator: Raul G Nogueira, MD, University of Pittsburgh Medical Center, Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Actual): May 12, 2022
• Study Completion (Actual): May 12, 2022

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Vascular Diseases; Ischemic; Revascularization; Ischemia; Brain; Ischemic Stroke; Cerebrovascular Disorders; Brain Infarction; Cerebral Ischemia; Brain Clot; Mechanical Thrombectomy; Neurovascular Intervention; Stent Retriever; Solitaire; Randomized Control; phenox; pRESET; pRESET Thrombectomy Device
• Additional Relevant MeSH Terms: Stroke; Cardiovascular Diseases; Vascular Diseases; Ischemic Stroke; Ischemia; Nervous System Diseases; Brain Diseases; Cerebrovascular Disorders; Pathologic Processes; Central Nervous System Diseases
• Other Study ID Numbers: pCT-001-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes