Acute Ischemic Stroke Clinical Trial
Official title:
A Randomized Study to Compare the Efficacy of Primary Thrombectomy With Double Stent (DS-EVT) Versus Primary Thrombectomy With One Stent (SS-EVT) as an Initial Attempt at Thrombectomy
The use of a double stent retriever (Dual-SR) has been proposed as a safe and effective technique. The invesigators hypothesized that the use of Dual-SR primary could lead to higher first-pass effect rates and better outcomes compared to Single-SR primary. Our goal is to develop a research project to provide additional information on the potential benefits of the simultaneous double stent approach primarily in stroke patients receiving TVS. A randomized study to compare the efficacy of double primary SR versus single primary SR
Status | Recruiting |
Enrollment | 180 |
Est. completion date | June 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion criteria: Clinic Age =18 and =85 years. Informed consent obtained from the patient or an acceptable surrogate for the patient (ie, next of kin or legal representative). A new disabling focal neurological deficit compatible with acute cerebral ischemia. Baseline NIHSS obtained before the procedure, = 6 points. Preictal mRS score of 0 or 2. Treatable as soon as possible and at least within 24 hours of symptom onset, defined as the time the patient was last seen well (at baseline). Patients for whom IV t-PA is indicated and who are available for treatment are treated with IV t-PA. For those patients for whom IV t-PA is indicated and available for treatment, IV t-PA should be administered as recommended in the AHA/ASA Guidelines for the Early Management of Patients with Acute Ischemic Stroke ( AIS). Neuroimaging Occlusion (flow TICI 0 or TICI 1), of the terminal internal carotid artery, segments or distal M1 of the basilar or middle cerebral artery, suitable for mechanical embolectomy, confirmed by conventional angiography. The patient is indicated for neurothrombectomy treatment by the Interventionist. Participating NRIs will have to complete a teaching module on the DS-EVT Exclusion criteria: Clinic Functional disability prior to stroke on the modified Rankin scale (mRS >2). Initial treatment with a different thrombectomy device. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories. Known bleeding diathesis, coagulation factor deficiency, or known oral anticoagulant therapy with INR > 3.0. Baseline platelet count < 50,000. Serious, advanced or terminal illness with an expected life expectancy of less than six months. Subjects with identifiable intracranial tumors. Brain vasculitis. Evidence of active systemic infection. Known current use of cocaine at the time of treatment. Woman of childbearing age who is known to be pregnant, and/or breastfeeding, or who has a positive pregnancy test at the time of admission. Patient participating in a study involving an investigational drug or device that may affect this study. Patients who are unlikely to be available for a 90-day follow-up (eg, homeless, visitor from abroad). Neurological imaging Hypodensity on CT or diffusion-restricted resulting in an ASPECTS score of < 6 on CT or < 5 on DMR (diffusion-weighted MRI). Evidence of hemorrhage on CT or MRI (the presence of microbleeds is allowed). Angiographic evidence of carotid artery dissection, high-grade stenosis impeding access to the clot, or vasculitis. Significant mass effect with midline shift. Patients with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion. Patients with occlusions in multiple vascular territories (for example, bilateral anterior circulation or anterior/posterior circulation). Evidence of intracranial tumor (except small meningiomas). Suspected aortic dissection, suspected septic embolus, or suspected bacterial endocarditis. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Vall d'Hebrón | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Reperfusion | Rate of satisfactory reperfusion at the end of procedure, defined as the achievement of a modified Thrombolysis in Cerebral Infarction - mTICI =2b in the target vessel in 3 passes and at the end of the procedure. | 4 months | |
Other | Procedure time | Procedure time, defined as the time from puncture to obtaining mTICI =2b or, if not obtained, to final angiography | 4 months | |
Other | National Institutes of Health Stroke Scale (NIHSS) at 24h | Neurological status at 24 hours, at day 5 (+/- 12 hours) or discharge, and at 90 days (+/- 14 days), determined by National Institutes of Health Stroke Scale [NIHSS score] range 0-42, with higher scores indicating greater stroke severity | 4 months | |
Other | Modified Rankin Scale (mRs) at 5 days | Modified Rankin Scale (mRS; range 0 [no symptoms] to 6 [death]) for the evaluation of neurological functional disability score at day 5 (+/- 12 hours) or at discharge and at 90 days | 4 months | |
Primary | Complete recanalization on first pass | Comparison of the complete recanalization rate in the first pass in the double stent group compared to the simple stent group, defined as TiCI greater than 2c on the Thrombolysis in Cerebral Infarction scale (eTICI scale) | 4 months | |
Secondary | Intracerebral hemorrhage | Evaluation of symptomatic or asymptomatic intracerebral hemorrhage at 24h evaluated by CT or MRI | 4 months | |
Secondary | Neurological impairment | Evaluation of neurological deterioration in National Institutes of Health Stroke Scale [NIHSS] >4; range 0-42, with higher scores indicating greater stroke severity at 24 hours (-8/+12h) | 4 months | |
Secondary | Embolization in new territories | Rate of embolization in a territory previously not affected in the initial cerebral angiogram. | 4 months | |
Secondary | Mortality | Mortality rate related to the procedure at 5 days (+/- 12h) or at discharge | 4 months | |
Secondary | Infarct in new territory | Presence of infarction in a previously unaffected vascular territory on baseline imaging, based on evaluation of 24-hour imaging (MRI/CT) after the procedure | 4 months |
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