Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-28 @ 4:29 AM
Study NCT ID:
NCT03328403
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: