Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03328403|
Recruitment Status : Completed
First Posted : November 1, 2017
Last Update Posted : September 30, 2019
Aim of Study:
- To develop a standardized patient selection criteria and imaging protocol for endovascular therapy in acute ischaemic stroke (AIS)
- To create a local efficacy and safety database for intra-arterial mechanical thrombectomy devices use
- To establish predictors for poor functional outcome despite successful recanalization
Subject and Site:
100 acute ischaemic stroke patients with large vessel occlusion At Queen Mary and Ruttonjee Hospital, Hong Kong
Duration of participation:
Subject must meet all inclusion criteria and none of the exclusion criteria
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|
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:
- NIHSS score at 24 hours and at 7 day or discharge if earlier
- Activities of daily living measured using Barthel index and NIHSS at 90 days
- 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
- 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
- Final infarct volume measured by plain CT brain at 3 days after procedure
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|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)|
|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|
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.
- 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.
- 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.
- 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.
- 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
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
|Queen Mary Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Mona Man-Yu Tse, MBBS, FHKAM||Queen Mary Hospital, Hong Kong|