Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion

NCT03328403 | Completed FDA Device

• 1 other identifier: UW 15-431
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of Study:

1. 1.To develop a standardized patient selection criteria and imaging protocol for endovascular therapy in acute ischaemic stroke (AIS)
2. 2.To create a local efficacy and safety database for intra-arterial mechanical thrombectomy devices use
3. 3.To establish predictors for poor functional outcome despite successful recanalization

Conditions

Acute Ischaemic Stroke

Keywords

Endovascular therapy; Mechanical thrombectomy; Acute ischaemic stroke treatment

Outcome Measures

Primary Outcomes (1)

• Modified Rankin scale

  The primary outcome is 90 days modified Rankin scale. The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death). A score of 2 or less indicates functional independence.

  90 days

Secondary Outcomes (3)

• National Institute of Health Stroke Severity Score (NIHSS)

  At 24 hours and at 7 day or discharge if earlier

• Activities of daily living

  90 days

• Percentage of successful recanalization

  1 day

Study Arms (2)

Aspiration First

EXPERIMENTAL

Aspiration thrombectomy with large bore catheters

Device: Aspiration First

Stent retriever first

EXPERIMENTAL

Thrombectomy with a licensed stent retriever device

Device: Stent retriever first

Interventions

Aspiration First DEVICE

Use aspiration system (mainly Penumbra) first, other devices would be used if the first device failed to open the occluded vessel satisfactorily, depending on clinical situation and the involved interventionists' preferences.

Aspiration First

Stent retriever first DEVICE

Use one of the stent retrievers (Trevo / Solitaire) first, other devices would be used if the first device failed to open the occluded vessel satisfactorily, depending on clinical situation and the involved interventionists' preferences.

Stent retriever first

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Onset: ≤ 4.5 hours from symptoms onset
• Age \< 80
• Premorbid modified Rankin Score (mRS) ≤ 2
• NIHSS 8 - 29
• Clear and definite symptoms and signs suggesting stroke with hemiparesis as one of the presenting symptoms
• Plain CT brain showed no evidence of intracerebral haemorrhage and ASPECTS ≥ 7
• Multiphasic CT angiogram confirmed proximal vessel occlusion at internal carotid artery (ICA), carotid T junction, proximal middle cerebral artery (M1 segment to proximal M2 with loss of all M2 branches), proximal anterior cerebral artery (segment A1) or basilar artery

You may not qualify if:

• Interventionist or angio-laboratory not available
• Neurological signs rapidly resolving
• NIHSS\>29
• Evidence of cerebral haemorrhage or subarachnoid haemorrhage on CT brain
• ASPECTS\<7
• Excessive tortuosity of the vessel precluding device delivery
• Known chronic renal failure with creatinine level \>250umol/L
• Known haemorrhagic diathesis
• Known coagulation factor deficiency
• Difficult blood pressure control with persistent systolic blood pressure \>185mg or diastolic blood pressure \>110mg despite aggressive blood pressure lowering therapy
• On anticoagulant and INR≥3
• On heparin in previous 48 hour and APTT\>2x of normal
• Platelet counts \<30
• Blood glucose \<2.7mmol/L
• Known severe allergies to contrast medium

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator
• Ruttonjee Hospital, Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Study Officials

• Mona Man-Yu Tse, MBBS, FHKAM

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Patients will be randomized to use either the Aspiration System or one of the stent-retreivers (Trevo / Solitaire) first. Other devices would be used if the first device failed to open the occluded vessel satisfactorily, depending on clinical situation and the involved interventionists' preferences.

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: November 1, 2017
• Study Start: September 17, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

HK (1)