Direct Mechanical Thrombectomy Versus Bridging Therapy

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Ischemic Stroke; Thrombectomy; Large-Artery Atherosclerosis (Embolus/Thrombosis)

Treatments: Device: Penumbra system for stent aspiration; Drug: recombinant tissue plasminogen activator; Device: Trevo and or Merci devices for stent retreival

Study type: Interventional

Funder types: Other

Identifiers

NCT05155540

0201218

Details and patient eligibility

About

This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt.

Full description

This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt. In the first arm, 17 patients were recruited and underwent direct mechanical thrombectomy without receiving recombinant tissue plasminogen activator. In the bridging therapy arm, 34 patients received first tissue plasminogen activator then underwent direct mechanical thrombectomy. The efficacy was evaluated by the NIHSS improvement 24 hours following stroke onset and the modified Rankin scale 3 months following stroke. Safety was assessed by the procedural complications rate especially the hemorhagic transformation.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with anterior ischemic stroke due to large vessel occlusion.
• A previous autonomous modified Rankin Scale (mRS) of less than 2.
• A National Institutes of Health Stroke Scale (NIHSS)≥4
• A groin puncture within 4.5 hours of the neurological deficit onset.

Exclusion criteria

• Imaging documentation of intracranial haemorrhage
• A premorbid mRS score of 2 or more
• Absence of diffusion perfusion mismatch in CT perfusion.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Direct mechanical thrombectomy

Active Comparator group

Description:

Direct mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous recombinant tissue plasminogen activator.

Treatment:

Device: Trevo and or Merci devices for stent retreival

Device: Penumbra system for stent aspiration

Bridging therapy

Active Comparator group

Description:

Mechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg

Treatment:

Device: Trevo and or Merci devices for stent retreival

Drug: recombinant tissue plasminogen activator

Device: Penumbra system for stent aspiration