Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA".

NCT05091320 | Unknown Phase 3

• 1 other identifier: Neurointervintion and stroke
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Mechanical thrombectomy recently has revolutionized the treatment of stroke. Trials have demonstrated the superiority of mechanical thrombectomy in large vessel occlusions, such as in the intracranialinternal carotid artery and proximal, middle cerebral artery (M1), middle cerebral artery trunk (M1), have relatively high rates of revascularization and favorable clinical outcomes after MT. , However second-order branches of the middle cerebral artery (M2) occlusions (postbifurcation in the Sylvian fissure) were underrepresented or not represented in the trials. Posing a more significant technical challenge to the available endovascular devices because of the smaller size and tortuosity of these arteries and the greater likelihood of recanalization with intravenous thrombolysis, the overall risk-benefit remains uncertain.

Conditions

Stroke, Acute Ischemic

Outcome Measures

Primary Outcomes (1)

• Clinical neurological outcome

  Clinical neurological outcome was evaluated at discharge (within one week from onset) and at 3 months by the neurologist in charge. by using National Institutes of Health Stroke Scale (NIHSS) Good clinical outcome at discharge was defined as a NIHSS score less than or equal to 2 or a decrease in NIHSS score greater than or equal to 10 points.

  3 months

Secondary Outcomes (1)

• Functional outcome

  3 months

Study Arms (2)

Mechanical thrombectomy

ACTIVE COMPARATOR

this arm will include all patient underwent mechanical thrombectomy, either alone or after failure of medical treatment.

Drug: Mechanical thrombectomy; Drug: medical treatment

medical managemnet

ACTIVE COMPARATOR

this arm will include all patients who received medical treatment only, either anti-platelet or alteplase.

Drug: medical treatment

Interventions

Mechanical thrombectomy DRUG

Mechanical thrombectomy is interventional method and the first line management in large vessel occlusion in acute ischemic stroke

Mechanical thrombectomy

medical treatment DRUG

medical management of patient according guide lines, either alteplase if presented in it's time window, or anti-platelet

Mechanical thrombectomy; medical managemnet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Cerebral infarction in anterior circulation involving occlusion of M2 MCA, proven by CTA
• With or without IV thrombolysis
• Access to endovascular treatment within 24 hours from onset.

You may not qualify if:

• Proven proximal occlusion of MCA.
• Disability prior to the stroke (mRS \>3)
• Opposition of the patient or their family

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecurer of neurology

Model Details: case control

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 25, 2021
• Study Start: December 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: October 25, 2021

Record last verified: 2021-10