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pRESET for Occlusive Stroke Treatment (PROST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994822
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
phenox Inc.

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
Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Nervous System Diseases Pathologic Processes Stroke, Ischemic Stroke, Acute Vascular Diseases Device: Mechanical Thrombectomy using the pRESET Thrombectomy device Device: Mechanical Thrombectomy using the Solitaire Revascularization Device Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, multi-center randomized
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
Primary Purpose: Treatment
Official Title: pRESET for Occlusive Stroke Treatment
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021

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




Primary Outcome Measures :
  1. Primary Effectiveness Endpoint: Patients with a Modified Rankin Scale (mRS) </= 2 [ Time Frame: 90 (+/-15) days ]
    Global disability assessed via the blinded evaluation of the proportion of patients with a Modified Rankin Scale (mRS) </= 2

  2. Primary Safety Endpoint: Device- or procedure-related symptomatic intracerebral hemorrhage (sICH) [ Time Frame: 24 (-8/+12) hours ]
    Proportion of subjects with device- or procedure-related symptomatic intracerebral hemorrhage (sICH)


Secondary Outcome Measures :
  1. Successful Revascularization measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI) [ Time Frame: During Index Procedure ]
    Difference in 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.

  2. Successful Revascularization on first pass measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI) [ Time Frame: During Index Procedure ]
    Proportion of target vessels with first-pass eTICI 2c or greater, separately per group and difference in these proportions, with 3 or fewer passes of the assigned study device

  3. Successful Revascularization measured per group using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI) [ Time Frame: During Index Procedure ]
    Final eTICI 2b50 or greater and eTICI 2c or greater proportions per group and differences in proportions.

  4. Successful Revascularization on first pass per group measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI) [ Time Frame: During Index Procedure ]
    Proportion of target vessels with first-pass eTICI 2b50, 2b67, 2c or 3, per group and comparison of proportions.

  5. Early Response [ Time Frame: Day 7 / Discharge (whichever is earlier) ]
    Proportion of subjects with "early response", defined as a NIHSS drop of ≥10 points from baseline or NIHSS score 0 or 1.

  6. Occurrence of all intracranial hemorrhage [ Time Frame: 24 (-8/+12) hours ]
    All intracranial hemorrhages using the Heidelberg Bleeding classification.

  7. Occurrence of stroke related and all-cause mortality [ Time Frame: 90 (+/-15) days ]
    Stroke-related mortality and overall mortality

  8. Neurological deterioration [ Time Frame: Day 7 / Discharge (whichever is earlier) ]
    Incidence of neurological deterioration from baseline NIHSS score through Day 7/discharge (whichever is earlier) post treatment (time zero). Neurological deterioration is defined as ≥ 4-point increase in the NIHSS score from the baseline score.

  9. Occurrence of procedure-related and device-related Serious Adverse Events [ Time Frame: 24 (-6/+24) hours ]

    Incidence of procedure-related and device-related serious adverse events (PRSAEs and DRSAEs) as adjudicated by the clinical events committee, and defined as:

    1. Vascular perforation
    2. Intramural arterial dissection
    3. Embolization to a new territory
    4. Access site complication requiring surgical repair or blood transfusion
    5. Intra-procedural mortality
    6. Device failure (in vivo breakage)
    7. Any other complications adjudicated by the CEC to be related to the procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Current participation in another investigation drug or device treatment study
  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. 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 currently uses 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 has undergone balloon angioplasty or stenting of the carotid artery
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994822


Contacts
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Contact: Gary Brogan +35391740103 gary.brogan@phenox.ie

Locations
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United States, Florida
University of Miami Recruiting
Coral Gables, Florida, United States, 33146
Contact: Robert M Starke, MD         
Baptist Health Research Institute Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Richardo A Hanel, MD         
Principal Investigator: Eric Sauvageau, MD         
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Diogo Haussen, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Michael Chen, MD         
Advocate Lutheran General Hospital Recruiting
Downers Grove, Illinois, United States, 60515
Contact: Demetrius Lopes, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Edgar Samaniego, MD         
United States, Massachusetts
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Ajit Puri, MD         
United States, New Jersey
JFK Medical Center Recruiting
Edison, New Jersey, United States, 08820
Contact: Jawad Kirmani, MD         
United States, New York
Buffalo General Medical Center Recruiting
Buffalo, New York, United States, 14203
Contact: Adnan H Siddiqui, MD         
The Mount Sinai Hosptial Active, not recruiting
New York, New York, United States, 10029
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Hormozd Bozorgchami, MD         
Germany
Universitätsklinikum Heidelberg Not yet recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Markus Möhlenbruch, Dr. med.         
Klinikum Bremen-Mitte Not yet recruiting
Bremen, Lower Saxony, Germany, 28205
Contact: Christian Roth, Dr. med.         
Helios Klinikum Erfurt GmbH Not yet recruiting
Erfurt, Thuringia, Germany, 99089
Contact: Joachim Klisch, Prof.         
Sponsors and Collaborators
phenox Inc.
Investigators
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Principal Investigator: Raul G Nogueira, MD Grady Memorial Hospital
Principal Investigator: Richardo A Hanel, MD Baptist Medical Center, Jacksonville
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Responsible Party: phenox Inc.
ClinicalTrials.gov Identifier: NCT03994822    
Other Study ID Numbers: pCT-001-19
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by phenox Inc.:
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
Additional relevant MeSH terms:
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Stroke
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes