Clinical trial NCT03144960: Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke
Official title: Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Stroke
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment Of Acute Occlusion In Ischemic Stroke by Mechanical Thrombectomy
timeFrame: 18 months
Secondary outcomes:
measure: The patients will be undergoing NIHSS score
timeFrame: 1 hour
measure: The patients will be undergoing ASPECTS score
timeFrame: 1 hour
measure: The patients will be undergoing CT/CT angiography
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
References:
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.