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Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion

Not Applicable
Not yet recruiting
Conditions
Acute Ischemic Stroke
Interventions
Device: an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systems
Registration Number
NCT06427187
Lead Sponsor
Assiut University
Brief Summary

Ischemic stroke continues to be of the leading causes of disability and death. Distal vessel occlusion one of most presenting and disabling varieties of ischemic stroke. Distal vessel occlusion stroke is a type of ischemic stroke that affects the small arteries in the brain, usually beyond the M2 segment of the middle cerebral artery. These strokes can cause various neurological symptoms depending on the location and size of the occluded vessel and the extent of the brain tissue damage

Detailed Description

DMVOs are defined by the Distal Thrombectomy Summit Group consensus statement as thromboembolic occlusion of the anterior cerebral artery, M2-M4 middle cerebral artery (MCA), posterior cerebral artery (PCA), posterior inferior cerebellar artery, anterior inferior cerebellar artery or superior cerebellar artery. It is estimated that 25-40% of all AIS is due to DMVO.Though distal vessel occlusion associated with poor disabling comorbidities'.With different aetiology weather primary Embolic from (heart, carotid or aorta),thrombotic (atherosclerotic, hypertension or Diabetes ,smoking \&hyperlipidaemia) or Secondary distal vessel occlusion that occurs as a complication of a proximal large vessel occlusion, either spontaneously or after treatment with intravenous thrombolysis or endovascular thrombectomy. This can be due to thrombus fragmentation and migration or incomplete reperfusion of the affected vascular territory . Endovascular thrombectomy is well established as a highly effective treatment for acute ischemic stroke (AIS) due to proximal, large vessel occlusions (PLVOs). Recent advances in stent retriever and aspiration catheter technology are more promising results to reach more distal vessels, with a good outcome. However, MT in M2 emerging with different technique using stent Retriever or aspiration or both nowadays, evidence of other MT in distal vessel occlusion is poor.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
30
Inclusion Criteria
  • a. Inclusion criteria:

    1. Diagnosis of an acute ischemic stroke due to an occlusion of the anterior cerebral artery (ACA) in the A1-A3 segment 2. Diagnosis of an acute ischemic stroke due to an occlusion of the middle cerebral artery in the distal M2 segment or the M3 segment.
Exclusion Criteria
  1. Posterior circulation small vessel occlusion
  2. Tandem lesions with occlusion of the ipsilateral ICA were excluded.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
distal vessel occlusion Mechanical thromectomyan array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systemsEach presenting Patient with acute distal vessel occlusion of anterior circulation with (A1-A3)or (M2-M3) either mechanical thrombectomy (MT) with or without intra-venous thrombolysis (IVT) according to standard medical guidelines. MT was performed using approved aspiration catheters or stent-retrievers or both.
Primary Outcome Measures
NameTimeMethod
modified Thrombolysis in Cerebral Infarction scale (mTICI)1 day , 10 day

grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2 grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory (e.g. in one major division of the middle cerebral artery (MCA) and its territory) grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory (e.g. in two major divisions of the MCA and their territories) grade 2c: near complete perfusion except for slow flow or distal emboli in a few distal cortical vessels this was not part of the original mTICI score, but was added later and has since become widely accepted as being part of the scoring 4 grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches

Thrombolysis in Cerebral Infarction (TICI)1 day , 10 day

The original description was based on the angiographic appearances of the treated occluded vessel and the distal branches:

grade 0: no perfusion grade 1: penetration with minimal perfusion grade 2: partial perfusion grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal grade 3: complete perfusion

Secondary Outcome Measures
NameTimeMethod
mRSthree months

90 Days modified Rankin scale (mRS) score The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke, as follows 0: No symptoms at all

1. No significant disability despite symptoms; able to carry out all usual duties and activities

2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance

3. Moderate disability; requiring some help, but able to walk without assistance

4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance

5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention

6. Dead

Safety outcomes were defined as 90-day mortality and occurrence of symptomatic intracranial haemorrhage (sICH).three months

Safety outcomes were defined as 90-day mortality and occurrence of symptomatic intracranial haemorrhage (sICH).

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