Status:
COMPLETED
SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Stryker Neurovascular
The University of Texas Health Science Center, Houston
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
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...
Detailed Description
SELECT 2 is a prospective, phase III randomized, international, multicenter, assessor-blinded controlled trial evaluating the efficacy and safety of thrombectomy in patients with large core on either ...
Eligibility Criteria
Inclusion
- Adults (18-85 years) with the final diagnosis of an acute ischemic stroke
- NIH Stroke Scale Score (NIHSS) ≥ 6
- Last known well to groin puncture or medical management between 0 to 24 hours
- Pre-stroke modified Rankin Scale score (mRS) of 0-1
- Eligible for thrombectomy or medical management
- Signed Informed Consent obtained
- Subject willing to comply with the protocol follow-up requirements
- Anticipated life expectancy of at least 3 months
- Specific Neuroimaging
- Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA
- Large infarct-core lesion on at least one of the following:
- 1. Non-Contrast CT (ASPECTS of 3-5),
- 2. CT perfusion (rCBF\<30% ≥50cc),
- 3. MRI-DWI (ADC\<620 ≥50cc)
Exclusion
- Inability to undergo CT angiography and/or CT perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)
- Co-morbid psychiatric or medical illnesses that would confound the neurological assessments
- Treatment with thrombolytic agent beyond 4.5 hours from last known well
- Treated with thrombolytic agent 3-4.5 hours after last known well AND any of the following:
- 1\) age \>80,
- 2\) current anticoagulant use,
- 3\) history of diabetes AND prior stroke,
- 4\) NIHSS \>25,
- 5\) ischemic involvement of \> 1/3 MCA territory
- Current participation in another investigational drug or device study.
- Neuroimaging Exclusion Criteria
- Patients who have both ASPECTS of 6-10 on non-contrast CT AND core volume \<50 cc on perfusion imaging
- Patients with very large core on non-contrast CT i.e. ASPECTS ≤ 2
- Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
- A significant mass effect with midline shift
- Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
- Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
- 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).
- Signs of established infarct and large area of cerebral edema on non-contrast CT
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2023
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT03876457
Start Date
October 11 2019
End Date
November 16 2023
Last Update
November 21 2024
Active Locations (31)
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1
Kaiser Permanente
Los Angeles, California, United States, 90027
2
Baptist Health
Jacksonville, Florida, United States, 32207
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
4
Ascension St. Vincent Hospital
Indianapolis, Indiana, United States, 46260