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Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke

Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03144960
Enrollment
20
Registered
2017-05-09
Start date
2017-11-30
Completion date
2019-12-31
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke

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.

Interventions

PROCEDUREMechanical Thrombectomy

mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Aged between 18 - 80 years old of both sex. 2. Acute ischemic stroke due to proved large-artery occlusion. 3. Ineligibility for IV thrombolysis. 4. A timeframe of ≤ 4.5 hours between stroke onset and the start of mechanical thrombectomy. 5. The patients included in this series should have an NIHSS score of at least 10 or fluctuating symptoms. 6. ASPECTS of 6 or \> 6 7. All patients will be undergoing CT/CT angiography before and after treatment

Exclusion criteria

1. Age older than 80 years or less than 18 2. Cerebral haemorrhage. 3. Acute infarction \> 1/3 of middle cerebral artery (MCA) territory on CT-scan. 4. A history of stroke in the last 6 weeks. 5. A time interval of \> 4.5 hours. 6. laboratory evidence of coagulation abnormalities. 7. Known arteriovenous malformation , neoplasm or aneurysm. 8. Woman at child bearing age who has a positive pregnancy test

Design outcomes

Primary

MeasureTime frameDescription
Treatment Of Acute Occlusion In Ischemic Stroke by Mechanical Thrombectomy18 monthsTreatment 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

MeasureTime frameDescription
The patients will be undergoing NIHSS score1 hourpatients with NIHSS score less than 10 non eligible for mechanical thrombectomy
The patients will be undergoing ASPECTS score1 hourpatients with ASPECTS score less than 6 non eligible for mechanical thrombectomy
The patients will be undergoing CT/CT angiography2 hoursct and ct angiography for exclusion of any bleeding or head injury

Contacts

Primary ContactEman Khedr, Professor
emankhedr99@yahoo.com+201005850632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026