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NCT Number: NCT06427187

Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion

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

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a. Inclusion criteria:
  • 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

  • Posterior circulation small vessel occlusion
  • Tandem lesions with occlusion of the ipsilateral ICA were excluded.

Treatment and study plan

an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systems

Device

each patient with distal vessel occlusion subjected to mechanical thrombectomy using aspiration technique or stent retriever

Primary outcomes

  1. Thrombolysis in Cerebral Infarction (TICI)

    Time frame: 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

  2. modified Thrombolysis in Cerebral Infarction scale (mTICI)

    Time frame: 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

Secondary outcomes

  1. mRS

    Time frame: three 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

    • No significant disability despite symptoms; able to carry out all usual duties and activities
    • Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • Moderate disability; requiring some help, but able to walk without assistance
    • Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • Dead

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

    Time frame: three months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed zayed, Master degree

CONTACT

[email protected]

+20109809943

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Outcomes of Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 23, 2024
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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