Acute Ischaemic StrokeNCT03328403
Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion
A study testing Aspiration First and Stent retriever first in people with Acute Ischaemic Stroke, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Acute Ischaemic Stroke
- What is being tested?
- Aspiration First and Stent retriever first
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteHong Kong
- Study dates
- 17 Sep 2015to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
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
Read the 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:
- 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
- Death
- Conditions
- Acute Ischaemic Stroke
- Being tested
- Aspiration First, Stent retriever first
- Keywords
- Endovascular therapy, Mechanical thrombectomy, Acute ischaemic stroke treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration FirstDevice
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.
Stent retriever firstDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Aspiration First | Experimental | Aspiration thrombectomy with large bore catheters Receives: Device: Aspiration First |
| Stent retriever first | Experimental | Thrombectomy with a licensed stent retriever device Receives: Device: Stent retriever first |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start17 Sep 2015
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischaemic StrokeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Ruttonjee Hospital, Hong Kong
- Responsible party
- Principal investigator, Dr Anderson Chun-On Tsang, The University of Hong Kong
- Investigators
- Mona Man-Yu Tse, MBBS, FHKAM, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328403
- Sponsor's protocol ID
- UW 15-431
- Status last verified
- Sep 2019
- First submitted
- 17 Oct 2017
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion
- ClinicalTrials.gov ID
- NCT03328403
- Acronym / sponsor ID
- UW 15-431
- Conditions
- Acute Ischaemic Stroke
- Keywords
- Endovascular therapy, Mechanical thrombectomy, Acute ischaemic stroke treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Ruttonjee Hospital, Hong Kong
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
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:
- 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
- Death
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aspiration First | Experimental | Device: Aspiration FirstAspiration thrombectomy with large bore catheters |
| Stent retriever first | Experimental | Device: Stent retriever firstThrombectomy with a licensed stent retriever device |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- Interventionist or angio-laboratory not available
- Neurological signs rapidly resolving
- NIHSS>29
- Evidence of cerebral haemorrhage or subarachnoid haemorrhage on CT brain
- ASPECTS<7
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspiration FirstUse 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. | Device | Aspiration First |
| Stent retriever firstUse 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. | Device | Stent retriever first |
Primary outcome
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.
3 secondary outcomes
National Institute of Health Stroke Severity Score (NIHSS)
Time frame: At 24 hours and at 7 day or discharge if earlier
Activities of daily living
Time frame: 90 days
Percentage of successful recanalization
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Man-Yu Tse, MBBS, FHKAM principal investigator
Queen Mary Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspiration First and Stent retriever first in people with Acute Ischaemic Stroke, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin scale (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.