MR CLEAN: a multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in The Netherlands.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27679

Enrollment

500

Registered

2009-05-07

Start date

2010-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Acute ischemic stroke, intracranial arterial occlusion, thrombolysis, mechanical thrombectomy

Interventions

Intra-arterial treatment (rtPA and/or mechanical thrombectomy) versus no intra-arterial treatment. The treatment is provided in addition to best medical management, including intravenous thrombolysis.

Eligibility

Inclusion criteria

Inclusion criteria: 1. A clinical diagnosis of acute stroke, with a deficit on the NIH stroke scale of > 2 points; 2. CT or MRI scan rules out intracranial hemorrhage; 3. Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA, DSA or transcranial Doppler/duplex (TCD); 4. The possibility to start treatment within 6 hours from onset; 5. Informed consent given; 6. Age 18 or over.

Exclusion criteria

Exclusion criteria: 1. Cerebral infarction within the previous 6 weeks; 2. History of intracerebal hemorrhage; 3. Severe head injury the previous 4 weeks; 4. Major surgery, gastrointestinal bleeding or urinary tract bleeding within 2 weeks; 5. Arterial blood pressure > 185/110 mmHg; 6. Blood glucose 22.2 mmol/l; 7. Platelet count 50 s or INR >1.7; 9. Intravenous treatment with thrombolytic therapy in a dose exceeding 0.9 mg/kg rtPA or 90 mg.

Design outcomes

Primary

Measure	Time frame
The score on the modified Rankin scale at 90 days.	—

Secondary

Measure	Time frame
Imaging parameters: 1. Vessel recanalization at 24-48 hours after treatment, assessed by CTA or MRA; 2. Infarct size at 24-48 hours assessed by CT; 3. (A-)symptomatic intracerebral hemorrhage at 24-48 hours assessed by CT. Clinical parameters: 1. Mortality at 1 week and at 90 days; 2. The score on the NIH stroke scale at 24-48 hours after treatment; 3. The score on the NIH stroke scale at 1 week or at discharge. Functional outcome: 1. Score on the EQ5D at 90 days; 2. Barthel index at 90 days; 3. Score on the Academic Linear Disability Scale at 90 days.	—

Measure

Time frame

Imaging parameters: 1. Vessel recanalization at 24-48 hours after treatment, assessed by CTA or MRA; 2. Infarct size at 24-48 hours assessed by CT; 3. (A-)symptomatic intracerebral hemorrhage at 24-48 hours assessed by CT. Clinical parameters: 1. Mortality at 1 week and at 90 days; 2. The score on the NIH stroke scale at 24-48 hours after treatment; 3. The score on the NIH stroke scale at 1 week or at discharge. Functional outcome: 1. Score on the EQ5D at 90 days; 2. Barthel index at 90 days; 3. Score on the Academic Linear Disability Scale at 90 days.

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Contacts

Public ContactP. Fransen

PO Box 2040

p.fransen@erasmusmc.nl+31 (0)10 7040704

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)