4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / pRESET for Occlusive Stroke Treatment (PROST)

pRESET for Occlusive Stroke Treatment (PROST)

Study Description
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
Study Design
Layout table for study information
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 : September 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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

Outcome Measures
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 ]
    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 patients with eTICI 2c or greater, following the first pass of the assigned study device

  3. Overall mortality following the index stroke [ Time Frame: 90 (+/-15) days ]
    Overall mortality following the index stroke

  4. 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


Eligibility Criteria
Layout table for eligibility information
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. 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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Gary Brogan +35391740103 gary.brogan@phenox.ie

Locations
Show Show 21 study locations
Sponsors and Collaborators
phenox Inc.
Investigators
Layout table for investigator information
Principal Investigator: Raul G Nogueira, MD Grady Memorial Hospital
Principal Investigator: Richardo A Hanel, MD Baptist Medical Center, Jacksonville
Tracking Information
First Submitted Date  ICMJE May 24, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date April 21, 2021
Actual Study Start Date  ICMJE October 4, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2019)
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • 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
  • 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2021)
  • 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.
  • 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
  • Overall mortality following the index stroke [ Time Frame: 90 (+/-15) days ]
    Overall mortality following the index stroke
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • Occurrence of all intracranial hemorrhage [ Time Frame: 24 (-8/+12) hours ]
    All intracranial hemorrhages using the Heidelberg Bleeding classification.
  • Occurrence of stroke related and all-cause mortality [ Time Frame: 90 (+/-15) days ]
    Stroke-related mortality and overall mortality
  • 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.
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE pRESET for Occlusive Stroke Treatment
Official Title  ICMJE pRESET for Occlusive Stroke 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Brain Diseases
  • Cardiovascular Diseases
  • Central Nervous System Diseases
  • Cerebrovascular Disorders
  • Ischemia
  • Nervous System Diseases
  • Pathologic Processes
  • Stroke, Ischemic
  • Stroke, Acute
  • Vascular Diseases
Intervention  ICMJE
  • Device: Mechanical Thrombectomy using the pRESET Thrombectomy device
    Clot removal using the pRESET Thrombectomy device
  • Device: Mechanical Thrombectomy using the Solitaire Revascularization Device
    Clot removal using the Solitaire Revascularization Device
Study Arms  ICMJE
  • Experimental: pRESET Thrombectomy Device
    Mechanical Thrombectomy using the pRESET Thrombectomy Device
    Intervention: Device: Mechanical Thrombectomy using the pRESET Thrombectomy device
  • Active Comparator: Solitaire Revascularization Device
    Mechanical Thrombectomy using the Solitaire Revascularization Device
    Intervention: Device: Mechanical Thrombectomy using the Solitaire Revascularization Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2019)
316
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gary Brogan +35391740103 gary.brogan@phenox.ie
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994822
Other Study ID Numbers  ICMJE pCT-001-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party phenox Inc.
Study Sponsor  ICMJE phenox Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raul G Nogueira, MD Grady Memorial Hospital
Principal Investigator: Richardo A Hanel, MD Baptist Medical Center, Jacksonville
PRS Account phenox Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP