Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in The Netherlands for Late Arrivals: MR CLEAN LATE

Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in The Netherlands for Late Arrivals: MR CLEAN LATE - MR CLEAN LATE

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55450

Enrollment

500

Registered

2017-09-11

Start date

2018-02-02

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain infarction ischemic stroke

Interventions

The intervention group will receive IAT with a stent retriever or other device approved by the steering committee. The control group will receive best medical treatment.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: o clinical diagnosis of acute ischemic stroke, o caused by proximal intracranial anterior circulation occlusion (distal intracranial carotid artery or middle (M1/M2 ) cerebral artery confirmed by neuro-imaging (CTA), o and presence of poor*, moderate or good collateral flow as shown by neuro-imaging (CTA) o CT or MRI ruling out intracranial hemorrhage, o Start of IA treatment (groin puncture) possible between 6 and 24 hours or last seen well

Exclusion criteria

Exclusion criteria: o Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2 o cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuroimaging in the territory of the middle cerebral artery o INR exceeding 3.0* o platelet count 50 sec* o visible infarction in > 1/3 of the territory of the middle cerebral artery o participation in trials other than current and MR ASAP. o ICA-T/M1 occlusion, NIHSS >=10, infarct core =2 (patient is eligible for direct EVT treatment, based on DAWN/DEFUSE 3 patient profile) Inclusion in other intervention trials during the study period is not allowed * In case there is no clinical indication to test for hemorrhagic diathesis, it may be assumed that the INR, APTT and platelet count are within these limits.

Design outcomes

Primary

Measure	Time frame
The primary outcome is the score on the mRS 90 days after inclusion in the study. The primary effect parameter should take the whole range of the mRS into account and is defined as the relative risk for improvement on the mRS estimated as a common odds ratio with ordinal logistic regression. Multivariable regression analysis will be used to adjust for chance imbalances in main prognostic variables between the intervention and control group, such as age, stroke severity (NIHSS), time since onset, previous stroke, atrial fibrillation and diabetes mellitus.	—

Measure

Time frame

The primary outcome is the score on the mRS 90 days after inclusion in the study. The primary effect parameter should take the whole range of the mRS into account and is defined as the relative risk for improvement on the mRS estimated as a common odds ratio with ordinal logistic regression. Multivariable regression analysis will be used to adjust for chance imbalances in main prognostic variables between the intervention and control group, such as age, stroke severity (NIHSS), time since onset, previous stroke, atrial fibrillation and diabetes mellitus.

—

Secondary

Measure	Time frame
Secondary outcomes include hemorrhage and stroke severity at 24 hours and 5-7 days, recanalization on CTA at 24 hours or MRA at 24-48 hours and when chosen for CTA at 24 hours; infarct size at 5-7 days on non-contrast CT will follow.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)