Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion

NCT ID: NCT03328403

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-17
• Study Completion Date: 2019-09-30

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

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

Conditions

Acute Ischaemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aspiration First

Aspiration thrombectomy with large bore catheters

Group Type: EXPERIMENTAL

Aspiration First

Intervention Type: 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.

Stent retriever first

Thrombectomy with a licensed stent retriever device

Group Type: EXPERIMENTAL

Stent retriever first

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role: collaborator

Ruttonjee Hospital, Hong Kong

UNKNOWN

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr Anderson Chun-On Tsang

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona Man-Yu Tse, MBBS, FHKAM

Role: PRINCIPAL_INVESTIGATOR

Queen Mary Hospital, Hong Kong

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

UW 15-431

Identifier Type: -

Identifier Source: org_study_id