Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke
Primary Purpose
Acute Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mechanical Thrombectomy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Stroke
Eligibility Criteria
Inclusion Criteria:
- Aged between 18 - 80 years old of both sex.
- Acute ischemic stroke due to proved large-artery occlusion.
- Ineligibility for IV thrombolysis.
- A timeframe of ≤ 4.5 hours between stroke onset and the start of mechanical thrombectomy.
- The patients included in this series should have an NIHSS score of at least 10 or fluctuating symptoms.
- ASPECTS of 6 or > 6
- All patients will be undergoing CT/CT angiography before and after treatment
Exclusion Criteria:
- Age older than 80 years or less than 18
- Cerebral haemorrhage.
- Acute infarction > 1/3 of middle cerebral artery (MCA) territory on CT-scan.
- A history of stroke in the last 6 weeks.
- A time interval of > 4.5 hours.
- laboratory evidence of coagulation abnormalities.
- Known arteriovenous malformation , neoplasm or aneurysm.
- Woman at child bearing age who has a positive pregnancy test
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
mechanical thrombectomy
Arm Description
The study will be performed involving ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset, mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption.
Outcomes
Primary Outcome Measures
Treatment Of Acute Occlusion In Ischemic Stroke by Mechanical Thrombectomy
Treatment of ischemic stroke patients after 4.5 hours from stroke onset by endovascular intervention by using Mechanical Thrombectomy techniques and without using Recombinant tissue-type plasminogen Activator and non eligible patients for Thrombectomy will be excluded.
The number of people will be participated into this study will be 20 aged 18 to 80 years old The patients will be undergoing NIHSS score , ASPECTS score The patients will be undergoing CT/CT angiography The patients will be undergoing mechanical thrombectomy Results will be collected and correlated with the prognosis of the outcomes
Secondary Outcome Measures
The patients will be undergoing NIHSS score
patients with NIHSS score less than 10 non eligible for mechanical thrombectomy
The patients will be undergoing ASPECTS score
patients with ASPECTS score less than 6 non eligible for mechanical thrombectomy
The patients will be undergoing CT/CT angiography
ct and ct angiography for exclusion of any bleeding or head injury
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03144960
Brief Title
Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke
Official Title
Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2017 (Anticipated)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Assessment of Therapeutic benefits and hazards of Mechanical Thrombectomy in Ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset.
Detailed Description
Stroke is an acute neurologic dysfunction of vascular origin with sudden or at least rapid occurrence of symptoms and signs corresponding to the involvement of focal areas in the brain.The two main types of stroke are ischemic and hemorrhagic.Thrombosis can form in the extracranial and intracranial arteries when the intima is roughened and plaque forms along the injured vessel.The endothelial injury permits platelets to adhere and aggregate, then coagulation is activated and thrombus develops at site of plaque.Blood flow through the extracranial and intracranial systems decreases, and the collateral circulation maintains function. When the compensatory mechanism of collateral circulation fails, perfusion is compromised, leading to decreased perfusion and cell death. Stroke is the third leading cause of death in the United States. Many people die each year from stroke in the United States.Stroke is the leading cause of serious, long-term disability in the United States. Nearly one fourth of strokes occur in people under the age of 65.High blood pressure is the most important risk factor for stroke. Intravenous recombinant tissue-type plasminogen activator is the only Food and Drug Administration approved treatment for acute ischemic stroke. Mechanical thrombectomy improves clinical outcomes in patients with acute ischemic stroke caused by a large vessel occlusion.There is no apparent benefit of intravenous thrombolysis to patients with ischemic stroke undergoing mechanical thrombectomy. The study will be performed involving ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mechanical thrombectomy
Arm Type
Other
Arm Description
The study will be performed involving ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset, mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption.
Intervention Type
Procedure
Intervention Name(s)
Mechanical Thrombectomy
Intervention Description
mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption
Primary Outcome Measure Information:
Title
Treatment Of Acute Occlusion In Ischemic Stroke by Mechanical Thrombectomy
Description
Treatment of ischemic stroke patients after 4.5 hours from stroke onset by endovascular intervention by using Mechanical Thrombectomy techniques and without using Recombinant tissue-type plasminogen Activator and non eligible patients for Thrombectomy will be excluded.
The number of people will be participated into this study will be 20 aged 18 to 80 years old The patients will be undergoing NIHSS score , ASPECTS score The patients will be undergoing CT/CT angiography The patients will be undergoing mechanical thrombectomy Results will be collected and correlated with the prognosis of the outcomes
Time Frame
18 months
Secondary Outcome Measure Information:
Title
The patients will be undergoing NIHSS score
Description
patients with NIHSS score less than 10 non eligible for mechanical thrombectomy
Time Frame
1 hour
Title
The patients will be undergoing ASPECTS score
Description
patients with ASPECTS score less than 6 non eligible for mechanical thrombectomy
Time Frame
1 hour
Title
The patients will be undergoing CT/CT angiography
Description
ct and ct angiography for exclusion of any bleeding or head injury
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 18 - 80 years old of both sex.
Acute ischemic stroke due to proved large-artery occlusion.
Ineligibility for IV thrombolysis.
A timeframe of ≤ 4.5 hours between stroke onset and the start of mechanical thrombectomy.
The patients included in this series should have an NIHSS score of at least 10 or fluctuating symptoms.
ASPECTS of 6 or > 6
All patients will be undergoing CT/CT angiography before and after treatment
Exclusion Criteria:
Age older than 80 years or less than 18
Cerebral haemorrhage.
Acute infarction > 1/3 of middle cerebral artery (MCA) territory on CT-scan.
A history of stroke in the last 6 weeks.
A time interval of > 4.5 hours.
laboratory evidence of coagulation abnormalities.
Known arteriovenous malformation , neoplasm or aneurysm.
Woman at child bearing age who has a positive pregnancy test
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Khedr, Professor
Phone
+201005850632
Email
emankhedr99@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17258667
Citation
Wahlgren N, Ahmed N, Davalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V, Lees KR, Roine RO, Soinne L, Toni D, Vanhooren G; SITS-MOST investigators. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007 Jan 27;369(9558):275-82. doi: 10.1016/S0140-6736(07)60149-4. Erratum In: Lancet. 2007 Mar 10;369(9564):826.
Results Reference
result
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Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke
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