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Brain DiseasesPROSTNCT03994822

pRESET for Occlusive Stroke Treatment

A study testing Mechanical Thrombectomy using the pRESET Thrombectomy device and Mechanical Thrombectomy using the Solitaire Revascularization Device in people with Brain Diseases and Cardiovascular Diseases, run by phenox Inc. at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mechanical Thrombectomy using the pRESET Thrombectomy device and Mechanical Thrombectomy using the Solitaire Revascularization Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
24 sitesin 2 countries
Study dates
4 Oct 2019to 12 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >/=18
  • Clinical signs consistent with acute ischemic stroke
  • 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.
  • Pre-stroke modified Rankin Score of 0 or 1
  • NIHSS ≥6 at the time of enrolment
  • 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:
  • Intracranial internal carotid
  • M1 and/or M2 segment of the MCA
  • Carotid terminus
  • Vertebral artery
  • 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:
  • MR diffusion-weighted imaging (DWI) ≤50cc
  • Computed tomography perfusion (CTP) core ≤50 cc
  • Subject is willing to conduct protocol-required follow-up visits.
  • A valid completed informed consent by participant or LAR (Legally Authorized Representative)

Who cannot join

  • Subject who has received IA-tPA prior to enrolment in the study
  • Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
  • Rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke
  • Known serious sensitivity to radiographic contrast agents
  • Known sensitivity to nickel, titanium metals, or their alloys
  • 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.)
  • Known renal failure as defined by a serum creatinine > 2.0 mg/dl (or 176.8 μmol/l) or glomerular filtration rate (GFR) < 30.
  • Subject who requires hemodialysis or peritoneal dialysis, or who has a contraindication to an angiogram for whatever reason.
  • Life expectancy of less than 90 days
  • Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
  • Suspicion of aortic dissection
  • 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.
  • 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).
  • 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
  • Subject who requires balloon angioplasty or stenting of the carotid artery at the time of the index procedure
  • Angiographic evidence of carotid dissection
  • Imaging exclusion criteria:
  • CT or MRI evidence of hemorrhage on presentation
  • CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma)
  • CT or MRI evidence of cerebral vasculitis
  • CT or MRI-DWI showing ASPECTS 0-5. Alternatively, if automated core volume assessment software is used, MRI-DWI or CTP core > 50cc.
  • CT/MRI shows evidence of carotid dissection or complete cervical carotid occlusion requiring a stent
  • 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.).
  • 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

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

United States19 sites

  • Grady Memorial Hospital

    Atlanta, Georgia, 30322

  • Buffalo General Medical Center

    Buffalo, New York, 14203

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • OhioHealth Research Institute

    Columbus, Ohio, 43214

  • University of Miami

    Coral Gables, Florida, 33146

  • Advocate Lutheran General Hospital

    Downers Grove, Illinois, 60515

  • JFK Medical Center

    Edison, New Jersey, 08820

  • Valley Baptist

    Harlingen, Texas, 78550

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Baptist Health Research Institute Jacksonville

    Jacksonville, Florida, 32207

  • NYU Langone Health

    New York, New York, 10016

  • The Mount Sinai Hosptial

    New York, New York, 10029

  • UPMC

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Providence Little Company of Mary Medical Center

    Santa Monica, California, 90404

  • Honor Health Research Institute

    Scottsdale, Arizona, 85251

  • Swedish Medical Center - Cherry Hill Campus

    Seattle, Washington, 98122

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • University of Massachusetts

    Worcester, Massachusetts, 01655

Other trials in United States

Germany5 sites

  • Klinikum Bremen-Mitte

    Bremen, Lower Saxony, 28205

  • Helios Klinikum Erfurt GmbH

    Erfurt, Thuringia, 99089

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, Schleswig-Holstein, 23562

  • Klinikum rechts der Isar Technische Universität München

    München, Bavaria, 81675

Other trials in Germany

About this study

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

Read the 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

Being tested
Mechanical Thrombectomy using the pRESET Thrombectomy device, Mechanical Thrombectomy using the Solitaire Revascularization Device
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
Medical subject headings
Brain Diseases, Cardiovascular Diseases, Central Nervous System Diseases, Cerebrovascular Disorders, Ischemia, Nervous System Diseases, Pathologic Processes, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mechanical Thrombectomy using the pRESET Thrombectomy deviceDevice

    Clot removal using the pRESET Thrombectomy device

  • Mechanical Thrombectomy using the Solitaire Revascularization DeviceDevice

    Clot removal using the Solitaire Revascularization Device

Study groups in NCT03994822
Study groupRoleWhat they receive
pRESET Thrombectomy DeviceExperimentalMechanical Thrombectomy using the pRESET Thrombectomy Device
Receives: Device: Mechanical Thrombectomy using the pRESET Thrombectomy device
Solitaire Revascularization DeviceActive comparatorMechanical Thrombectomy using the Solitaire Revascularization Device
Receives: Device: Mechanical Thrombectomy using the Solitaire Revascularization Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 90 (+/-15) days

  2. Primary Safety Endpoint: Device- or procedure-related symptomatic intracerebral hemorrhage (sICH)

    Proportion of subjects with device- or procedure-related symptomatic intracerebral hemorrhage (sICH)

    Measured: 24 (-8/+12) hours

Secondary outcomes (4)

  1. 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.

    Measured: During Index Procedure

  2. 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

    Measured: During Index Procedure

  3. Overall mortality following the index stroke

    Overall mortality following the index stroke

    Measured: 90 (+/-15) days

  4. Distribution of mRS shift across the entire spectrum of disability

    Distribution of mRS shift across the entire spectrum of disability

    Measured: 90 (+/-15) days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study start4 Oct 2019
  3. Primary completion12 May 2022
  4. Study completion12 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, multi-center randomized
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03994822
Sponsor's protocol ID
pCT-001-19
Acronym
PROST
Status last verified
Feb 2022
First submitted
24 May 2019
Last updated
21 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mechanical Thrombectomy using the pRESET Thrombectomy device and Mechanical Thrombectomy using the Solitaire Revascularization Device in people with Brain Diseases and Cardiovascular Diseases, run by phenox Inc. at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint: Patients with a Modified Rankin Scale (mRS) </= 2 (time frame: 90 (+/-15) days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03994822.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.

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