Mechanical Thrombectomy in Acute Ischemic Stroke Beyond the Time of Window (AIS)
|ClinicalTrials.gov Identifier: NCT04087382|
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Background: intravenous alteplase appears to be much less effective at opening proximal occlusions of the major intracranial arteries, which account for more than one third of cases of acute anterior-circulation stroke and expanding time window using mechanical thrombectomy can improve clinical outcome in patients that would have only received conservative treatment.
The aim of this work is to evaluate the effectiveness of endovascular therapy within 24 hours of symptom onset and to compare clinical outcome of endovascular therapy with the standard medical therapy at the end of 3rd month follow up.
Material and Methods 57 subjects presenting with an acute ischemic stroke caused by occlusion of the proximal middle cerebral artery (M1 segment) or Internal carotid artery ( ICA segment) within 24 hours from symptom onset as documented by Ct, and or MRI perfusion were recruited consecutively from 2 University hospitals Ain shams University Hospital (32 Patients) and Aswan University (25 patients). Assessment of each subject was performed using NIHSS, and MRS, Aspect score, before intervention. Follow up was done using the same clinical scale one week and the 3 month after the onset.
Primary outcome NIHSS and MRS at the end of 3 month after the onset. secondary outcome complications (cerebral Hge) and death at 3 months.
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke||Device: thrombectomy Other: non intervention group||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mechanical Thrombectomy in Acute Ischemic Stroke Beyond the Time of Window: Non Randomized Controlled Clinical Trial|
|Actual Study Start Date :||January 15, 2019|
|Actual Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||October 20, 2019|
Active Comparator: Intervention group
it included 32 patients with acute ischemic stroke beyond the time of window (more than 6 hours) assigned to mechanical thrombectomy) plus the conventional treatment (Aspirin 150 mg and atorvastatin 40 mg).
Transfemoral a microcatheter with its distal end was positioned a few millimeters beyond the distal aspect of the clot, the guide wire was exchanged by Solitaire stent device. The device was held in place when 3 mm was out of the microcatheter. The microcatheter was slowly pulled back to deploy the TR or ST device over the clot.
it included 25 patients with acute ischemic stroke beyond the time of window (more than 6 hours) who received medical treatment (Aspirin 150 mg and atorvastatin 40 mg).
Other: non intervention group
medical treatment (Asprin, statin, nootropic drug)
- 1- Measuring the Modified Rankin Score (MRS) on day 90 [ Time Frame: 3 months ]1- Measuring the Modified Rankin Score (MRS) on day 90 (ranging from, 0 to 6, with higher scores indicating greater disability). Favorable outcome was defined as achieving functional independence (mRS of 0,1or 2) poor outcome was defined as MRS of 3-5.
- 2- Measuring the changes in NIHSS on day 90 [ Time Frame: 3 months ]2- Changes in National Institute of Health Stroke Scale (NIHSS) were also measured at baseline (pre-thrombectomy) and on day 90. Favorable outcome when the score decrease by 4 or more point of the score.
- 1-Estimate the number and percent of participants who have vascular recanalization [ Time Frame: 3 months ]1-Estimate the number and percent of patients who have vascular recanalization according to thrombolysis in cerebral ischemia (TICI) score. TICI categories span from no perfusion (grade 0) to complete perfusion (grade 3). The "partial perfusion" category (grade 2) is defined as cases in which contrast passes the obstruction but with rates of entry and wash-out slower than normal and is subdivided into 2 subcategories, 2a and 2b. Successful vascular recanalization was defined as TICI grade 2b to 3.
- 2- Estimate the number of participants who developed complications [ Time Frame: 3 months ]2-estimate the number of patients who developed complication death (mRS=6) symptomatic intracerebral hemorrhage, and arterial dissection.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087382
|Contact: Abdalla M khalil, professor||01001286173 ext email@example.com|
|Contact: Ahmed El-bassiony, professor||01222132125 ext firstname.lastname@example.org|
|Cairo, Cairo, Egypt, Egypt|
|Aswan, Select State/Province, Egypt, 11577|
|Principal Investigator:||Eman M khedr, Professor||Assiut University|