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Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion

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ClinicalTrials.gov Identifier: NCT03328403
Recruitment Status : Completed
First Posted : November 1, 2017
Last Update Posted : September 30, 2019
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
Ruttonjee Hospital, Hong Kong
Information provided by (Responsible Party):
Dr Anderson Chun-On Tsang, The University of Hong Kong

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Acute Ischaemic Stroke Device: Aspiration First Device: Stent retriever first Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion
Actual Study Start Date : September 17, 2015
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2019

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.




Primary Outcome Measures :
  1. Modified Rankin scale [ Time Frame: 90 days ]
    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 Outcome Measures :
  1. National Institute of Health Stroke Severity Score (NIHSS) [ Time Frame: At 24 hours and at 7 day or discharge if earlier ]
    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.

  2. Activities of daily living [ Time Frame: 90 days ]
    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.

  3. Percentage of successful recanalization [ Time Frame: 1 day ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328403


Locations
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Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Ruttonjee Hospital, Hong Kong
Investigators
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Principal Investigator: Mona Man-Yu Tse, MBBS, FHKAM Queen Mary Hospital, Hong Kong

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Responsible Party: Dr Anderson Chun-On Tsang, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03328403     History of Changes
Other Study ID Numbers: UW 15-431
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dr Anderson Chun-On Tsang, The University of Hong Kong:
Endovascular therapy
Mechanical thrombectomy
Acute ischaemic stroke treatment
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia