A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

Oriental Collaboration Group on Emerging Advanced Therapy for Neurovascular Diseases Consortium-Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study (OCEAN-AIS-EVT REGISTRY)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864638
• Other study ID #: OCEAN-AIS-EVT REGISTRY
• Status: Recruiting
• Start date: May 10, 2023
• Est. completion date: August 31, 2028

Study information

• Verified date: August 2023
• Source: Changhai Hospital
• Contact: Pengfei Yang, M.D.
• Phone: 86-21-31161784
• Email: 15921196312[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.

Description:

The OCEAN-AIS-EVT-Registry is a multicenter, observational, registry study, and aims to assess the safety and outcome of endovascular treatment for acute ischemic stroke in real clinical practice. The primary endpoint is functional outcome, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±14 days).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: August 31, 2028
• Est. primary completion date: August 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of AIS with anterior or posterior circulation LVO confirmed by CTA, MRA or DSA;
• To receive endovascular treatment;
• Agree to participate in the study and signed informed consent form.

Exclusion Criteria:

• This study does not set exclusion criteria

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Large Vessel Occlusion
• Stroke
• Thrombectomy
• Thrombosis

Locations

Country	Name	City	State
China	Jianimin Liu	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death	All-cause death	7 days and 90 days
Other	Intracerebral hemorrhage(ICH)	symptomatic ICH, asymptomatic ICH. The Heidelberg bleeding classification categorizes intracranial hemorrhages occurring after ischemic stroke and reperfusion therapy.	90 days
Other	Procedure related complication	Procedure related complication	within 30 days after procedure
Other	adverse event (special concern)	adverse event (special concern)	within 30 days after procedure
Other	Device related complications	Device related complications	within 30 days after procedure
Primary	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.	90days
Secondary	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.	90days
Secondary	NIHSS at 24 hours	Change in stroke severity (NIHSS score) at 24 hours post treatment. The value range 0-42: higher scores mean a worse outcome.	24 hours post treatment
Secondary	NIHSS at 7 days	Change in stroke severity (NIHSS score) at 7 days post procedure. The value range 0-42: higher scores mean a worse outcome.	7 days post procedure
Secondary	Reperfusion outcome	Reperfusion outcome (eTICI 2b or greater) in final angiogram. The expanded treatment in cerebral infarction (eTICI) score is a modified from the modified treatment in cerebral infarction (mTICI) and thrombolysis in cerebral infarction (TICI) scales. The value range 0-3: higher scores mean a better outcome.	Immediately post-procedure
Secondary	Reperfusion outcome	Reperfusion outcome (eTICI 2b or greater) at 7 days post procedure. The expanded treatment in cerebral infarction (eTICI) score is a modified from the modified treatment in cerebral infarction (mTICI) and thrombolysis in cerebral infarction (TICI) scales. The value range 0-3: higher scores mean a better outcome.	7 days post procedure