pRESET for Occlusive Stroke Treatment (PROST)

April 20, 2023 updated by: phenox Inc.
Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
340

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
90 (+/-15) days
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)
24 (-8/+12) hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Successful Revascularization measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)
Time Frame: 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.
During Index Procedure
Successful Revascularization on first pass measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)
Time Frame: During Index Procedure
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
Time Frame: 90 (+/-15) days
Overall mortality following the index stroke
90 (+/-15) days
Distribution of mRS shift across the entire spectrum of disability
Time Frame: 90 (+/-15) days
Distribution of mRS shift across the entire spectrum of disability
90 (+/-15) days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
phenox Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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