Thrombectomy in patients ineligible for iv tPA
- Conditions
- I63Cerebral infarction
- Registration Number
- DRKS00005792
- Lead Sponsor
- niversitätsKlinikum HeidelbergNeurologische KlinikAbteilung Neuroradiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 4
Moderate to severe stroke (NIHSS>7 and <26)
Ineligibility for iv tPA and no prior iv tPA therapy
Premorbid mRS 0-1
Life expectancy > 6 Months
Treatment can be accomplished within 8 hours after stroke onset
Informed consent by the patient, legal guardian, or independent physician
Imaging criteria:
Occlusion of the M1 segment of the middle cerebral artery (MCA), and/or the intracranial segment of the distal internal carotid artery (ICA), determined by MRA or CTA
CT and CBV map on CTP or DWI with an ASPECT score of 7-10
Patient is eligible for and receives IV tPA according to licensing criteria
Patient with an INR of >3
Patient is an active participant in another drug or device treatment trial for any disease state,
or patient is expected to start participation in another drug or device treatment trial while
enrolled in this protocol, unless approved by Sponsor.
Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.
Patient has carotid dissection, high grade stenosis = 70% proximal to occlusion that requires stenting, or excessive tortuosity to gain access to occlusion, as determined by MRA/ CTA of neck and head.
Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection or aneurysm, no arterial transfemoral access)
Patient has history of contraindication for contrast medium.
Patient is known to have infective endocarditis
CT scan or MRI with evidence of: Mass effect or intracranial tumor, or hypodensity on
unenhanced CT and CBV drop on CBV maps on CTP, or, alternatively as per institutional
standard, restricted diffusion on DWI with an ASPECT score of 6 or less
Female of childbearing potential who is known to be pregnant and/or lactating or who has a
positive pregnancy test on admission.
Patients anticipated life expectancy is less than 6 Months.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Degree of disability after stroke assessed by modified Rankin Scale (mRS) outcome at 90 days poststroke
- Secondary Outcome Measures
Name Time Method Good neurological outcome with 90-day mRS=2 or 90-day NIHSS score improvement =10 from baseline<br>Excellent neurological outcomes with 90-day mRS=1<br>Infarct volume at 30 (-/+ 6) hours (CT or MRI).<br>Difference of infarct volume from infarct volume as predicted by pretreatment imaging<br>Functional health status and quality of life 90 (±14) days after stroke (EQ-5D)<br>For the endovascular treatment group successful recanalization will be defined as TICI 2b or 3.