EnDovascular therapy plus best medical treatment (BMT) versus BMT alone for MedIum VeSsel Occlusion sTroke - a prAgmatic, international, multicentre, randomized triaL (DISTAL)
- Conditions
- brain infarctionIschemic stroke1000796310014523
- Registration Number
- NL-OMON56450
- Lead Sponsor
- niversity Hospital Basel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
1. Acute ischemic stroke
2. Treatment (arterial puncture) can be initiated
2.1. Within 6 hours of last seen well (LSW)
OR
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)
3. Isolated medium vessel occlusion (i.e. an occlusion of the co-/non-dominant
M2, the M3/M4 segment of the MCA, the A1/A2/A3 segment of the ACA or the P1/P2
segment of the PCA) confirmed by CT or MRI Angiography
4. National Institute of Health Stroke Scale (NIHSS) Score of >= 4 points or
symptoms deemed clearly disabling by treating physician (i.e. aphasia,
hemianopia, etc.)
5. Age >=18 years
6. Deferred Written informed consent.
7. Agreement of treating physician to perform endovascular procedure
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.
7. Known history of arterial tortuosity, pre-existing stent, other arterial
disease and/or known disease at the arterial access site that would prevent the
device from reaching the target vessel and/or preclude safe recovery after EVT
8. Known, severe comorbidities, which will likely prevent improvement or
follow-up (active cancer, alcohol/drug abuse or dementia)
9. Radiological confirmed evidence of mass effect or intracranial tumour
(except small meningioma)
10. Radiological confirmed evidence of cerebral vasculitis
11. Evidence of vessel recanalization prior to randomisation
12. Participation in another interventional trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the degree of dependency and disability in everyday life<br /><br>(measured with the mRS) at 90 days.</p><br>
- Secondary Outcome Measures
Name Time Method