Direct Mechanical Thrombectomy Versus Bridging Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Open-label, non-randomized, prospective, double-arm clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Direct mechanical thrombectomy

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

Group Type ACTIVE_COMPARATOR

Trevo and or Merci devices for stent retreival

Intervention Type DEVICE

FDA approved devices for stent retrieval during mechanical thrombectomy

Penumbra system for stent aspiration

Intervention Type DEVICE

FDA approved devices for stent aspiration during mechanical thrombectomy

Bridging therapy

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

Group Type ACTIVE_COMPARATOR

Trevo and or Merci devices for stent retreival

Intervention Type DEVICE

FDA approved devices for stent retrieval during mechanical thrombectomy

Penumbra system for stent aspiration

Intervention Type DEVICE

FDA approved devices for stent aspiration during mechanical thrombectomy

recombinant tissue plasminogen activator

Intervention Type DRUG

FDA approved drug for treatment of acute ischemic stroke within 4.5 hours of strokeonset

Interventions

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Trevo and or Merci devices for stent retreival

FDA approved devices for stent retrieval during mechanical thrombectomy

Intervention Type DEVICE

Penumbra system for stent aspiration

FDA approved devices for stent aspiration during mechanical thrombectomy

Intervention Type DEVICE

recombinant tissue plasminogen activator

FDA approved drug for treatment of acute ischemic stroke within 4.5 hours of strokeonset

Intervention Type DRUG

Other Intervention Names

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No other names

Eligibility Criteria

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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.