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Mechanical Thrombectomy in Acute Ischemic Stroke Beyond the Time of Window (AIS)

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ClinicalTrials.gov Identifier: NCT04087382
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
Ain Shams University
Aswan University
Information provided by (Responsible Party):
Eman M. Khedr, Assiut University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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).
Device: thrombectomy
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.

non-intervention group
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)




Primary Outcome Measures :
  1. 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. 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.


Secondary Outcome Measures :
  1. 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. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Patients Aged between 18 and 80 years old.
  2. Patients with acute ischemic stroke due to occlusion of the MCA or ICA suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram.

4. Patients with symptoms onset between 6- 24 hours from arrival to the time of femoral puncture.

Exclusion criteria

A. Clinical exclusion criteria:

  1. Patients known to have hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 2.0.
  2. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological evaluations; mRS score before the onset of stroke must be ≤ 1.

B. Neuroimaging exclusion criteria:

  1. Patients with hypodensity on CT accounting to an ASPECTS score of <7.
  2. Patients with CT or MRI evidence of hemorrhage (the presence of micro-bleeds is allowed).
  3. Patients Significant mass effect with midline shift on CT brain.
  4. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) on CT brain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087382


Contacts
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Contact: Abdalla M khalil, professor 01001286173 ext 088 abdallah_khalil_91@yahoo.com
Contact: Ahmed El-bassiony, professor 01222132125 ext 002 arbassiouny@yahoo.com

Locations
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Egypt
Ahmed El-Bassiony Recruiting
Cairo, Cairo, Egypt, Egypt
Abdalla Khalil Completed
Aswan, Select State/Province, Egypt, 11577
Sponsors and Collaborators
Assiut University
Ain Shams University
Aswan University
Investigators
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Principal Investigator: Eman M khedr, Professor Assiut University

Publications:

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Responsible Party: Eman M. Khedr, Professor of Neurology, Assiut University
ClinicalTrials.gov Identifier: NCT04087382     History of Changes
Other Study ID Numbers: M thrombectomy in late AIS
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia