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SELECT 2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT03876457
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : October 16, 2019
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
Amrou Sarraj, The University of Texas Health Science Center, Houston

Brief Summary:

SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: ≥50cc) or both and are treated within 0-24 hours from last known well.

The second aim is to look at the correlation of imaging profiles with thrombectomy clinical outcomes and treatment effect. This will be evaluated by comparing the outcomes in patients with discordant imaging profile and assessing if thrombectomy outcome rates and treatment effect will differ in patients with discordant imaging profiles (favorable CT/unfavorable perfusion imaging and unfavorable CT/favorable perfusion imaging).


Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Device: Endovascular thrombectomy with stent retrievers: Trevo®, Solitaire®, and EmboTrap Revascularization Device Other: Medical Management Not Applicable

Detailed Description:

SELECT 2 is a prospective, randomized, international, multicenter, assessor-blinded controlled trial evaluating the efficacy and safety of thrombectomy in patients with large core on either CT or advanced perfusion imaging treated within 0-24 hours from last known well. The secondary aim is to look at the correlation of imaging profiles with thrombectomy clinical outcomes and treatment effect.

Patients with the final diagnosis of an acute ischemic stroke due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: ≥50cc) or both within 0-24 hrs from last known well will be randomized in a 1:1 ratio into thrombectomy plus medical management vs medical management alone. Patient outcomes will be measured at baseline, 24 hours post, discharge, 30 days and 90 days.

The primary endpoint is the Modified Rankin Scale (mRS) at 90 (+/- 15) days. The primary outcome is a shift on 90-day mRS. The 2nd primary outcome is favorable clinical outcomes: mRS score of 0-2. Secondary outcomes are safety outcomes such the incidence of symptomatic intracranial hemorrhage (sICH per SITS-MOST) and Imaging endpoints such as infarct volume on MRI diffusion-weighted imaging (DWI) sequence (or CT if MRI not feasible) 24 to 72 hours after randomization. CT images will be read by iSchemaView automated ASPECTS as well as by a physician. In cases where there is disagreement, the physician reading will override the automated software reading. CT/MR perfusion images with mismatch determination will be read by iSchemaView automated RAPID software. All the images will be adjudicated by a blinded core lab at the University of Texas-Medical School at Houston.

A maximum of 560 patients will be randomized across the study sites. Covariate adaptive randomization will be used to balance the distribution of important variables. Interim analyses will be conducted at 200 and 380 patients, at which time the study may stop for efficacy or futility.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SELECT 2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
Actual Study Start Date : October 11, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Arm Intervention/treatment
Experimental: Endovascular Thrombectomy plus Medical Management Device: Endovascular thrombectomy with stent retrievers: Trevo®, Solitaire®, and EmboTrap Revascularization Device
Patients randomized to endovascular thrombectomy arm will receive thrombectomy plus medical management. They will be treated with thrombectomy devices (stent‐retrievers) with/without suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and EmboTrap Revascularization Device. Stent retrievers will be used as the primary mode of thrombectomy with adjunctive use of the aspiration devices approved by the FDA (MicroVention SOFIA Catheter, and the Penumbra thrombectomy system) permitted in the study.

Other: Medical Management
Patients will receive standard AHA guideline-directed medical therapy, which will include IV-tPA in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria. For non-tPA treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-tPA patients will be treated based on standard study site protocols for these patients.

Active Comparator: Medical Management Other: Medical Management
Patients will receive standard AHA guideline-directed medical therapy, which will include IV-tPA in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria. For non-tPA treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-tPA patients will be treated based on standard study site protocols for these patients.




Primary Outcome Measures :
  1. Change in Modified Rankin Scale (mRS) score [ Time Frame: baseline, 90 days ]

    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.

    Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.

    Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.

    Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.

    Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

    Score 6: Dead


  2. Number of participants with favorable clinical outcomes defined as mRS scores of 0-2. [ Time Frame: 90 days ]

    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.

    Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.

    Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.

    Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.

    Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

    Score 6: Dead



Secondary Outcome Measures :
  1. Number of participants with symptomatic intracranial hemorrhage (sICH) per SITS-MOST [ Time Frame: Up to 24 hours after randomization ]
    NIHSS worsening of 4 or more points associated with sICH per Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) definition assessed within 24 hours after randomization

  2. Mortality [ Time Frame: 90 days ]
  3. Number of participants with groin hematomas, infections or any vascular injury cause by the endovascular procedure [ Time Frame: Up to 72 hours after procedure ]
  4. Length of hospital stay [ Time Frame: From admission date to discharge date (about 1 week) ]
  5. Discharge location [ Time Frame: discharge (about 1 week after randomization) ]
  6. NIH Stroke Scale score at 24 hours [ Time Frame: 24 hours after randomization ]
  7. NIH Stroke Scale score at discharge or day 5-7 (whichever comes earlier) [ Time Frame: at discharge (which is about 1 week after randomization) or Day 5-7, whichever comes earlier ]
  8. Neuro-QoL score [ Time Frame: 90 days ]
  9. Infarct volume [ Time Frame: 24 to 72 hours after randomization ]
    Infarct volume on MRI diffusion-weighted imaging (DWI) sequence (or CT if MRI not feasible) 24 to 72 hours after randomization

  10. Lesion growth [ Time Frame: 24 to 72 hours after randomization ]
    Lesion growth between the RAPID identified ischemic core on baseline imaging and the infarct volume

  11. Number of participants with successful reperfusion [ Time Frame: 24 to 72 hours after randomization ]
    Successful reperfusion defined as DWI lesion volume minus Tmax>6 seconds greater than 50%

  12. Number of participants with recanalization of the primary arterial occlusive lesion [ Time Frame: 24 hours after randomization ]
    Recanalization of the primary arterial occlusive lesion, assessed by a modified Thrombolysis in Cerebral Infarction scores of 2b (50% to 75% reperfusion), 2c (>75% to 99% reperfusion) or 3 (complete reperfusion)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults (18-85 years) with the final diagnosis of an acute ischemic stroke
  2. CT-angiogram or MR-angiogram proven large artery occlusion in the distal ICA or MCA M1 locations
  3. NIHSS ≥ 6
  4. Last known well to groin puncture or medical management between 0 to 24 hours
  5. Baseline modified Rankin Scale score of 0-1
  6. Eligible for thrombectomy with stent retriever or medical management
  7. Signed Informed Consent obtained
  8. Subject willing to comply with the protocol follow-up requirements
  9. Anticipated life expectancy of at least 3 months
  10. IV-tPA eligible patients treated per FDA guidelines

Specific Neuroimaging Inclusion Criteria:

  1. ICA or MCA M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) determined by MRA or CTA
  2. Non-contrast ASPECTS scores of 3-10 as determined by the treating physician, without use of automated ASPECTS.

    The definitions of CT imaging profiles are:

    1. ASPECTS ≥6 for favorable profiles
    2. ASPECTS 3-5 for unfavorable profiles*

      • ASPECTS 0-2 are not included in this study due to the expected poor outcome in these patients.
  3. CTP inclusion criteria:

The definitions of CTP imaging profiles are:

  1. rCBF (<30%) <50cc for favorable profiles
  2. rCBF (<30%) ≥50cc for unfavorable profiles

MR perfusion will be allowed if CT perfusion is not available. The definitions of MR Perfusion imaging profiles are:

  1. ADC <620 <50cc for favorable profiles
  2. ADC <620 ≥50cc for unfavorable profiles

Exclusion Criteria:

  1. Inability to undergo CT-Angiography and/or CT/MR Perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)
  2. Co-morbid psychiatric or medical illnesses that would confound the neurological assessments

Neuroimaging Exclusion Criteria

  1. Patients who have both favorable CT and favorable CTP/MRP
  2. Patients with very large core on imaging on non contrast CT i.e. ASPECTS ≤ 2
  3. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
  4. Significant mass effect with midline shift
  5. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
  6. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
  7. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
  8. Signs of established infarct and large area of cerebral edema on non-contrast CT

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): NCT03876457


Contacts
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Contact: Amrou Sarraj, MD 713-500-7075 amrou.sarraj@uth.tmc.edu
Contact: Bita Imam, PhD 713-500-7194 bita.imam@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Amrou Sarraj, MD    713-500-7075    amrou.sarraj@uth.tmc.edu   
Contact: Bita Imam, PhD    713-500-7194    bita.imam@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Stryker Neurovascular
Investigators
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Principal Investigator: Amrou Sarraj, MD The University of Texas Health Science Center, Houston

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Responsible Party: Amrou Sarraj, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03876457    
Other Study ID Numbers: HSC-MS-18-0997
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
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
Keywords provided by Amrou Sarraj, The University of Texas Health Science Center, Houston:
Ischemic stroke
Large vessel occlusion
Endovascular thrombectomy
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia