Trial record 3 of 6 for:    trevo

Trevo and Medical Management Versus Medical Management Alone in Wake Up and Late Presenting Strokes (DAWN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Stryker Neurovascular
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT02142283
First received: May 15, 2014
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.


Condition Intervention
Ischemic Stroke
Device: Trevo Thrombectomy Procedure
Other: Medical Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention

Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • Weighted modified Rankin Scale (mRS) score [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Stroke-related mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Good functional outcome [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    The proportion of subjects with a good functional outcome at 90 days, defined as mRS 0-2.

  • Early response [ Time Frame: 5-7 Days ] [ Designated as safety issue: No ]
    The proportion of subjects with "early response" at Day 5-7/Discharge (whichever is earlier), defined as a National Institutes of Health Stroke Scale (NIHSS) drop of ≥10 from baseline or NIHSS score 0 or 1.

  • All cause mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Median final infarct size [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The median final infarct size at 24 hours from randomization, by MRI T2/Flair or CT.

  • Revascularization rates [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Revascularization rates at 24 hours from randomization, by CT-MR core lab assessment of vessel patency on CTA/MRA.

  • Vessel reperfusion rates [ Time Frame: Immediately after device usage and at the end of the thrombectomy procedure ] [ Designated as safety issue: No ]
    Vessel reperfusion rates (percentages) post device and post procedure, by angiography core lab measurement of modified TICI ≥ 2b (Treatment arm only).

  • Symptomatic intracranial hemorrhage [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Symptomatic intracranial hemorrhage, by ECASS III definition, within 24 hours post randomization.

  • Neurological deterioration from baseline NIHSS score [ Time Frame: 5-7 days ] [ Designated as safety issue: Yes ]
    Neurological deterioration from baseline NIHSS score through Day 5-7/discharge (whichever is earlier) post randomization. Neurological deterioration is defined as ≥ 4 point increase in the NIHSS score from the baseline score.

  • Procedure-related and device-related SAEs [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Procedure-related and device-related serious adverse events (SAEs) through 24 hours post randomization (Treatment arm only).


Estimated Enrollment: 500
Study Start Date: July 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trevo Thrombectomy Procedure
Trevo Thrombectomy Procedure and Medical Management
Device: Trevo Thrombectomy Procedure
Other Names:
  • Trevo ProVue Retriever
  • Trevo XP ProVue Retriever
Other: Medical Management
Other Name: Medical Management per each institution's standard of care
Active Comparator: Medical Management
Medical Management
Other: Medical Management
Other Name: Medical Management per each institution's standard of care

Detailed Description:

The study is a prospective, randomized, multi-center, Phase II/III (feasibility/pivotal), adaptive, controlled trial, designed to demonstrate that mechanical thrombectomy using the Trevo Retriever with medical management is superior to medical management alone in improving clinical outcomes at 90 days in appropriately selected wake up and late presenting acute ischemic stroke subjects.

The intent of this study is to support the use of the Trevo Retriever beyond the currently labeled 8 hour indicated time limit in wake up, unclear onset, and late presenting ischemic stroke subjects, who currently have no other option besides medical management of their symptoms.

Patients with wake-up strokes, strokes with unclear onset time, and witnessed late presenting strokes may potentially benefit from intra-arterial reperfusion therapy. However, an important indicator of whether subjects will benefit or not during this later time window is the confirmation of a large vessel occlusion (LVO), and assessment of the core infarct volume relative to the volume of salvageable penumbra. Therefore, standardized imaging selection of subjects is required for inclusion into the study.

This trial has been designed with subject safety in mind, as a seamless Phase II (feasibility) / Phase III (pivotal) adaptive design, in order to address the concerns around potential unknown harms to enrolled subjects. This study will help to answer the question of whether carefully selecting subjects by using Clinical Imaging Mismatch will allow acute ischemic stroke patients who present at or beyond 6 hours from Time Last Seen Well (TLSW) to be considered for intra-arterial intervention. If Trevo thrombectomy plus medical management leads to better clinical outcomes over medical management alone, more patients in the future could receive endovascular treatment (either in addition to or in lieu of IV tPA).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:

    1. Subject has failed IV t-PA therapy (defined as a confirmed persistent occlusion 60 min after administration)
    2. Subject is contraindicated for IV t-PA administration
  2. Age ≥18
  3. Baseline NIHSS ≥10 (assessed within one hour prior to measuring core infarct volume)
  4. Subject can be randomized between with 6 to 24 hours after time last known well
  5. No significant pre-stroke disability (pre-stroke mRS must be 0 or 1)
  6. Anticipated life expectancy of at least 6 months
  7. Subject willing/able to return for protocol required follow up visits
  8. Subject or subject's Legally Authorized Representative (LAR) has signed the study Informed Consent form*

Imaging Inclusion Criteria:

  1. < 1/3 MCA territory involved, as evidenced by CT or MRI
  2. Occlusion of the intracranial ICA and/or MCA-M1 as evidenced by MRA or CTA
  3. Clinical Imaging Mismatch (CIM) defined as one of the following on RAPID MR-DWI or CTP-rCBF maps:

    1. 0-20 cc core infarct and NIHSS ≥ 10 (and age ≥ 80 years old)
    2. 0-30 cc core infarct and NIHSS ≥ 10 (and age < 80 years old)
    3. 31 cc to < 50 cc core infarct and NIHSS ≥ 20 (and age < 80 years old)

General Exclusion Criteria:

  1. History of severe head injury within past 90 days with residual neurological deficit, as determined by medical history
  2. Rapid improvement in neurological status to an NIHSS <10 or evidence of vessel recanalization prior to randomization
  3. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept)
  4. Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment
  5. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol)
  6. Renal failure as defined by a serum creatinine >3.0 mg/dL (264 µmol/L) NOTE: subjects on renal dialysis may be treated regardless of serum creatinine levels
  7. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR > 3.0 or PTT > 3 times normal; If factor Xa inhibitor (e.g. apixaban) < 24 hrs ago must have normal ecarin clotting time and if 24-48 hrs ago must have normal PTT.
  8. Any active or recent hemorrhage within the past 30 days
  9. Baseline platelet count < 50,000/uL
  10. History of severe allergy (more than rash) to contrast medium
  11. Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using medication the subject can be enrolled
  12. Female who is pregnant or lactating at time of admission
  13. Current participation in another investigational drug or device study or registry
  14. Presumed septic embolus, or suspicion of bacterial endocarditis
  15. Treatment with any cleared thrombectomy devices or other intra-arterial (neurovascular) therapies prior to randomization

Imaging Exclusion Criteria:

  1. Evidence of intracranial hemorrhage on CT/MRI
  2. Evidence of internal carotid artery flow limiting dissection on CTA/MRA
  3. Severe proximal extra-cranial carotid artery stenosis, or occlusion of any etiology, where concurrent vessel angioplasty or stenting is expected to be necessary and the procedure cannot be delayed until after the 24 (-6/+24) hours assessments have been completed
  4. Excessive tortuosity of cervical vessels on CTA/MRA that would likely preclude device delivery/deployment
  5. Suspected cerebral vasculitis based on medical history and CTA/MRA
  6. Suspected aortic dissection based on medical history and CTA/MRA
  7. Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the Trevo device
  8. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories
  9. Significant mass effect with midline shift as confirmed on CT/MRI
  10. Evidence of intracranial tumor (except small meningioma) as confirmed on CT/MRI
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02142283

Contacts
Contact: Julie Moore, BSc 510-413-2701 julie.moore@stryker.com
Contact: Amelia Saliba, BA 510-413-2634 amelia.saliba@stryker.com

Locations
United States, Michigan
St. Joseph Mercy - Oakland Not yet recruiting
Pontiac, Michigan, United States, 48341
Contact: Lynn Boomer, RN, BSN    248-858-3756    boomerl@trinity-health.org   
Principal Investigator: Andrew Xavier, MD         
Sub-Investigator: Aniel Majjhoo, MD         
United States, New Jersey
Capital Health System Recruiting
Trenton, New Jersey, United States, 08638
Contact: Cynthia Lewis-Diaz, RN,MHA    609-384-6287    cdiaz@capitalhealth.org   
Principal Investigator: Erol Veznedaroglu, MD         
Sub-Investigator: Mandy J Binning, MD         
United States, Ohio
Riverside Methodist Hospital/ Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Brittany Latoche       brittany.latoche@ohiohealth.com   
Principal Investigator: Ronald Budzik, MD         
Sub-Investigator: Nirav Vora, MD         
Sub-Investigator: Peter Pema, MD         
Sub-Investigator: Thomas Davis, MD         
Sponsors and Collaborators
Stryker Neurovascular
Investigators
Principal Investigator: Tudor G Jovin, MD University of Pittsburg Medical Center Stroke Institute
Principal Investigator: Raul Nogueira, MD Marcus Stroke & Neuroscience Center, Grady Memorial Hospital
  More Information

No publications provided

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT02142283     History of Changes
Other Study ID Numbers: T4024
Study First Received: May 15, 2014
Last Updated: September 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stryker Neurovascular:
Mechanical thrombectomy
Acute ischemic stroke
Wake up stroke
Late presenting stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on October 01, 2014