Multi Center Clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands.

Multi Center Clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands. - MR CLEAN

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39683

Enrollment

500

Registered

2010-02-18

Start date

2010-12-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

brain infarct stroke

Interventions

The intervention contrast is endovascular treatment versus no endovascular treatment. The treatment is provided in addition to best medical management (aspirin, stroke unit treatment and intravenous

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *A clinical diagnosis of acute stroke, with a deficit on the NIH stroke scale of more than 2 points. • CT or MRI scan ruling out intracranial hemorrhage. • Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA or DSA. • The possibility to start treatment within 6 hours from onset. • Informed consent given. • Age 18 or over.

Exclusion criteria

Exclusion criteria: - cerebral infarction in past 6 weeks -history in intracerebral bleeding -RR > 185/110 unresponsive to antihypertensive agents -blood glucose of < 2.7 or > 22.2 -Clinical signs of hemorrhagic diathesis or platelet count <90 x 10*9/L, APTT>50 sec or INR >1.7 - intravenous treatment with thrombolysis with a dose exceeding 0.9mg/kg or 90 mg -patients who are treated with intravenous thrombolysis while having cantra-indications for it.;Exclusion criteria for mechanical thrombectomy - carotid artery stenosis over 70% (NASCETT) which cannot be stented -RR > 185/110 -Blood glucose < 2.7 or >22.2 -INR > 3.0 or platelet count < 40 x 10*9

Design outcomes

Primary

Measure	Time frame
The primary outcome is the score on the modified Rankin scale 90 days after inclusion in the study.	—

Secondary

Measure	Time frame
Imaging: -Vessel recanalization at 24 hours after treatment, assessed by CTA or MRA. The criteria for recanalization on CTA or MRA are based on a modified AOL score and the clot burden score -Infarct size at 24 hours assessed by CT, using standard methods, including manual tracing of the infarct perimeter and semiautomated pixel thresholding. -CTA or MRA at 72 hours will be compared with baseline vessel imaging data, to estimate the recanalization rate. Perfusion CT at baseline is optional, but available at most centers. Infarct size at 24 hours will be compared with plain CT and perfusion CT results at baseline. Clinical parameters -NIHSS , including NIH supplemental motor score, at 24 hours. -NIHSS at 1 week or at discharge. Functional outcome at three months -Barthel -EQ5D	—

Measure

Time frame

Imaging: -Vessel recanalization at 24 hours after treatment, assessed by CTA or MRA. The criteria for recanalization on CTA or MRA are based on a modified AOL score and the clot burden score -Infarct size at 24 hours assessed by CT, using standard methods, including manual tracing of the infarct perimeter and semiautomated pixel thresholding. -CTA or MRA at 72 hours will be compared with baseline vessel imaging data, to estimate the recanalization rate. Perfusion CT at baseline is optional, but available at most centers. Infarct size at 24 hours will be compared with plain CT and perfusion CT results at baseline. Clinical parameters -NIHSS , including NIH supplemental motor score, at 24 hours. -NIHSS at 1 week or at discharge. Functional outcome at three months -Barthel -EQ5D

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)