Clinical Trial TitleSELECT 2: A randomized controlled trial to optimize patient’s selection for endovascular treatment in acute ischemic stroke.
National Clinical Trial Number:NCT03876457
Clinical Trial Protocol Description:
This is a research study to find out if mechanical thrombectomy is better than medical management in treating patients who have a large stroke. Additionally, this study aims to examine if images obtained by CT scan can identify patients for thrombectomy just as well as perfusion imaging (how blood flows through your brain), a different type of imaging.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are an adult (18-85 years of age) with the final diagnosis of an acute ischemic stroke.
- Have an NIHSS ≥ 6.
- Last known well to groin puncture or medical management between 0 to 24 hours.
- Have a pre-stroke modified Rankin Scale score (mRS) of 0-1.
- Are eligible for thrombectomy with stent retriever or medical management.
- Have signed Informed Consent obtained.
- Are willing to comply with the protocol follow-up requirements.
- Have anticipated life expectancy of at least 3 months.
You will be excluded from the study if any of the following criteria apply to you:
- Are inable to undergo CT angiography and/or CT perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy).
- Have co-morbid psychiatric or medical illnesses that would confound the neurological assessments
- Have treatment with tPA beyond 4.5 hours from last known well.
- Have been treated with tPA 3‐4.5 hours after last known well AND any of the following:
- age >80,
- current anticoagulant use
- history of diabetes AND prior stroke
- NIHSS >25
- ischemic involvement of > 1/3 MCA territory
- Are currently participation in another investigational drug or device study.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.