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Status unknownNCT03144960Updated May 9, 2017

Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke

An interventional study of Mechanical Thrombectomy in Acute Stroke, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Assessment of Therapeutic benefits and hazards of Mechanical Thrombectomy in Ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset.

Read the 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.

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Conditions studied

  • Acute Stroke
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    mechanical thrombectomy

    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.

    Procedure: Mechanical Thrombectomy

Interventions

  • ProcedureMechanical Thrombectomy

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 18 months

Secondary outcomes

  1. The patients will be undergoing NIHSS score

    patients with NIHSS score less than 10 non eligible for mechanical thrombectomy

    Time frame: 1 hour

  2. The patients will be undergoing ASPECTS score

    patients with ASPECTS score less than 6 non eligible for mechanical thrombectomy

    Time frame: 1 hour

  3. The patients will be undergoing CT/CT angiography

    ct and ct angiography for exclusion of any bleeding or head injury

    Time frame: 2 hours

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 17258667 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03144960
Lead sponsor
Assiut University
Responsible party
AHMohamed (Dr, Assiut University) — Principal investigator
First posted
May 9, 2017
Start date
Nov 2017 (estimated)
Primary completion
Nov 2018 (estimated)
Completion
Dec 2019 (estimated)
Last update
May 9, 2017

Study contacts

Eman Khedr, Professor
Contact
emankhedr99@yahoo.com
+201005850632

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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