NL-OMON56450
Not yet recruiting
Not Applicable
EnDovascular therapy plus best medical treatment (BMT) versus BMT alone for MedIum VeSsel Occlusion sTroke - a prAgmatic, international, multicentre, randomized triaL (DISTAL) - DISTA
niversity Hospital Basel0 sites100 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- brain infarction
- Sponsor
- niversity Hospital Basel
- Enrollment
- 100
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Acute ischemic stroke
- •2\. Treatment (arterial puncture) can be initiated
- •2\.1\. Within 6 hours of last seen well (LSW)
- •2\.2\. Within 6 to 24 hours of LSW AND
- •CT Criteria: Evidence of a hypoperfusion\-hypodensity mismatch (Absence of
- •hypodensity on the non\-contrast CT within \>\= 90% of the area of the hypoperfused
- •lesion on perfusion CT)
- •MRI Criteria: Evidence of a diffusion\-hyperintensity mismatch (Absence of
- •hyperintensity on fluid\-attenuated inversion recovery (FLAIR) imaging within \>\=
- •90% of the area of the diffusion weighted imaging (DWI) lesion)
Exclusion Criteria
- •1\. Acute intracranial haemorrhage
- •2\. Patient bedridden or presenting from a nursing home
- •3\. In\-Hospital Stroke
- •4\. Known (serious) sensitivity to radiographic contrast agents, nickel,
- •titanium metals or their alloys
- •5\. Foreseeable difficulties in follow\-up due to geographic reasons (e.g.
- •patients living abroad)
- •6\. Evidence of an ongoing pregnancy prior to randomization. A negative
- •pregnancy test before randomisation is required for all women with
- •child\-bearing potential.
Outcomes
Primary Outcomes
Not specified
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