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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03876457




Registration number
NCT03876457
Ethics application status
Date submitted
8/03/2019
Date registered
15/03/2019

Titles & IDs
Public title
SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
Scientific title
SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
Secondary ID [1] 0 0
G180275, Pro00056862
Universal Trial Number (UTN)
Trial acronym
SELECT2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Endovascular Thrombectomy
Other interventions - Medical Management

Experimental: Endovascular Thrombectomy plus Medical Management -

Active comparator: Medical Management -


Treatment: Devices: Endovascular Thrombectomy
Patients randomized to endovascular thrombectomy arm will receive thrombectomy plus medical management. They will be treated with thrombectomy devices (stent-retrievers or aspiration devices) 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 FDA-approved stent retrievers: the Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with or without aspiration, will be left up to the interventionalist, with any of the FDA-approved devices approved in the study protocol or a combination of them.

Other interventions: Medical Management
Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis 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-thrombolysis patients will be treated based on standard study site protocols for these patients.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up
Timepoint [1] 0 0
90 days
Secondary outcome [2] 0 0
Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up
Timepoint [2] 0 0
90 days
Secondary outcome [3] 0 0
Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria
Timepoint [3] 0 0
24 hours
Secondary outcome [4] 0 0
Number of Participants With Neurological Worsening Defined as a =4-point Increase on the NIHSS Score Due to the Stroke Itself
Timepoint [4] 0 0
24 hours
Secondary outcome [5] 0 0
Number of Mortalities Within 90-day Follow-up
Timepoint [5] 0 0
90 days
Secondary outcome [6] 0 0
Number of Procedural Complications
Timepoint [6] 0 0
24 hours
Secondary outcome [7] 0 0
Successful Reperfusion in the EVT Group, Defined as Modified Thrombolysis in Cerebral Ischemia (mTICI) Grade of 2b or Higher
Timepoint [7] 0 0
at the end of endovascular thrombectomy procedure
Secondary outcome [8] 0 0
Discharge Location
Timepoint [8] 0 0
day 5-7 after randomization/at discharge (whichever is later)
Secondary outcome [9] 0 0
Number of Participants That Showed Early Neurological Improvement, Defined as Improvement of =8 Points on NIHSS at 24 Hours of Presentation or an NIHSS of 0-1
Timepoint [9] 0 0
24 hours
Secondary outcome [10] 0 0
Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up
Timepoint [10] 0 0
90 days
Secondary outcome [11] 0 0
The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score
Timepoint [11] 0 0
1 year
Secondary outcome [12] 0 0
Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up
Timepoint [12] 0 0
1 year
Secondary outcome [13] 0 0
Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up
Timepoint [13] 0 0
1 year
Secondary outcome [14] 0 0
Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up
Timepoint [14] 0 0
1 year

Eligibility
Key inclusion criteria
1. Adults (18-85 years) with the final diagnosis of an acute ischemic stroke
2. NIH Stroke Scale Score (NIHSS) = 6
3. Last known well to groin puncture or medical management between 0 to 24 hours
4. Pre-stroke modified Rankin Scale score (mRS) of 0-1
5. Eligible for thrombectomy or medical management
6. Signed Informed Consent obtained
7. Subject willing to comply with the protocol follow-up requirements
8. Anticipated life expectancy of at least 3 months

Specific Neuroimaging

1. 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
2. Large infarct-core lesion on at least one of the following:

* 2.1. Non-Contrast CT (ASPECTS of 3-5),
* 2.2. CT perfusion (rCBF<30% =50cc),
* 2.3. MRI-DWI (ADC<620 =50cc)
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to undergo CT angiography and/or CT perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)
2. Co-morbid psychiatric or medical illnesses that would confound the neurological assessments
3. Treatment with thrombolytic agent beyond 4.5 hours from last known well
4. 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
5. Current participation in another investigational drug or device study.

Neuroimaging Exclusion Criteria

1. Patients who have both ASPECTS of 6-10 on non-contrast CT AND core volume <50 cc on perfusion imaging
2. Patients with very large core on non-contrast CT i.e. ASPECTS = 2
3. Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
4. A 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/11/2023
Sample size
Target
Accrual to date
Final
352
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - South Western Sydney Clinical School - Liverpool
Recruitment hospital [2] 0 0
The Royal Adelaide Hospital (RAH) - Adelaide
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
New Zealand
State/province [16] 0 0
Canterbury
Country [17] 0 0
Spain
State/province [17] 0 0
Badalona
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Valladolid
Country [20] 0 0
Switzerland
State/province [20] 0 0
Basel

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospitals Cleveland Medical Center
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Stryker Neurovascular
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of Texas Health Science Center, Houston
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amrou Sarraj, MD
Address 0 0
Case Western Reserve University - University Hospitals Cleveland Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03876457