Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion

Aim of Study:

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

Study Design:

Prospective

Subject and Site:

100 acute ischaemic stroke patients with large vessel occlusion At Queen Mary and Ruttonjee Hospital, Hong Kong

Duration of participation:

2 years

Entry Criteria:

Subject must meet all inclusion criteria and none of the exclusion criteria

Consent:

Both English and Chinese versions of Informed consent are available and will be obtained from patient or his/her next of kin

Study Overview

• Status: Completed
• Conditions: Acute Ischaemic Stroke
• Intervention / Treatment: Device: Aspiration First; Device: Stent retriever first

Detailed Description

Our study aim to set a standard patient selection and imaging protocol based on previous positive trials for endovascular therapy in AIS patients. Local efficacy and safety data of the FDA mechanical devices mainly Penumbra Aspiration System and Solitaire Flow Restoration device will be collected to create a local database for future service development. Clinical predictors for poor clinical outcomes despite successful recanalization will be looked for.

Intra-arterial treatment consisted of arterial catheterization with a micro-catheter and micro-guide wire to the level of occlusion. Mechanical treatment could involve thrombus aspiration technique or use of a retrievable stent. The method of intra-arterial treatment will leave to the discretion of the involved interventionist. Only devices that have received U.S. Food and Drug Administration (FDA) or Conformite Europeenne (CE) approval will be used in the trial. One or more members of each intervention team have to have completed at least five full procedures with a particular type of device.

Outcome and Safety Measures:

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.

Secondary outcomes include:

1. NIHSS score at 24 hours and at 7 day or discharge if earlier
2. Activities of daily living measured using Barthel index and NIHSS at 90 days
3. Percentage of successful recanalization, defined as modified Thrombolysis in Cerebral Infarction (mTICI) of 2b (more that 50% of distal branches visible) or 3 (all distal branches visible) assessed at the end of procedure
4. Efficacy of work flow with time measure on onset to CT, CT to groin puncture, puncture to reperfusion and number of pass of device before successful recanalization
5. Final infarct volume measured by plain CT brain at 3 days after procedure
6. Death

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Seizure as presenting symptoms with post-ictal hemiparesis
• Life expectancy < 3months
• Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aspiration First; Aspiration thrombectomy with large bore catheters	Device: Aspiration First; 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.
Experimental: Stent retriever first; Thrombectomy with a licensed stent retriever device	Device: Stent retriever first; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institute of Health Stroke Severity Score (NIHSS)	NIHSS score at 24 hours and at 7 day or discharge if earlier. NIHSS score describe the clinical severity of stroke symptoms, and is scored from 0 (no symptoms) to 42 (most severe deficits). The total NIHSS score before, at 24 hours after intervention and subsequent follow up will be assessed.	At 24 hours and at 7 day or discharge if earlier
Activities of daily living	Activities of daily living measured using modified Barthel index (mBI). modified Barthel Index is a measurement of independence of daily living, the score ranges from 0 to 100, with higher score correlating to better outcome.	90 days
Percentage of successful recanalization	Percentage of successful recanalization, defined as modified Thrombolysis in Cerebral Infarction (mTICI) of 2b (more that 50% of distal branches visible) or 3 (all distal branches visible) assessed at the end of procedure	1 day

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Queen Mary Hospital, Hong Kong; Ruttonjee Hospital, Hong Kong
• Investigators: Principal Investigator: Mona Man-Yu Tse, MBBS, FHKAM, Queen Mary Hospital, Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 28, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Endovascular therapy; Mechanical thrombectomy; Acute ischaemic stroke treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: UW 15-431

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes