Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChanghai Hospital
About this trial
A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acute ischemic stroke caused by anterior or posterior circulation vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
Undergo intravascular therapy (i.e. access to a cath lab and an arterial puncture)
The patient or his/her legal representative agreed to participate in the study and has signed the informed consent.
Disqualifiers
None
Trial population
All acute ischemic stroke patients receiving endovascular treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endovascular treatment
DeviceEndovascular treatment, such as mechanical thrombectomy with stent, aspiration catheter or stent assisted by intermediate aspiration catheter, as well as combination of mechanical thrombectomy with intra-arterial thrombolysis
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: Endovascular treatment1 intervention
Trial outcomes
Primary outcomes
1
Functional outcome
Shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days). The value range 0-6: higher scores mean a worse outcome.
Time frame
90daysSecondary outcomes
1
Dichotomized modified Rankin scale (mRS)
Dichotomized modified Rankin scale (mRS) at 90 days after the procedure (0-1 versus 2-6, 0-2 versus 3-6, 0-3 versus 4-6). The value range 0-6: higher scores mean a worse outcome.
Time frame
90days2
NIHSS at 24 hours
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours post- procedure. The value range 0-42: higher scores mean a worse outcome.
Time frame
24 hours post-procedure3
NIHSS at 7 days
National Institutes of Health Stroke Scale (NIHSS) score at 7 days post procedure. The value range 0-42: higher scores mean a worse outcome.
Time frame
7 days post procedure4
Reperfusion outcome
Immediate target vessel recanalization rate post-procedure: defined as proportion of subjects with extended thrombolysis in cerebral infarction (eTICI) score is 2b to 3 The value range 0-3: higher scores mean a better outcome.
Time frame
Immediately post-procedureOther outcomes
1
Death
All-cause death
Time frame
7 days and 90 days2
Intracerebral hemorrhage(ICH)
Intracranial hemorrhage, including symptomatic intracranial hemorrhage (sICH) and asymptomatic intracranial hemorrhage
Time frame
90 days3
Procedure related complication
Procedure related complication
Time frame
within 30 days after procedure4
Device related complications
Device related complications
Time frame
within 30 days after procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov