NL-OMON29036Not yet recruitingNot Applicable
IBIS: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-IminoBiotin in acute Ischemic Stroke due to large vessel occlusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Haaglanden Medisch Centrum
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Adults (age > 18 years for males and age >49 years for females)
- •A clinical diagnosis of AIS
- •Disabling stroke defined as a baseline NIH stroke scale score =5
- •Alberta Stroke Program Early CT score (ASPECTS) > 4 on CT (or MRI)
- •Presence of an intracranial LVO of the anterior circulation (distal ICA, M1 or proximal M2 segment of the MCA) on CTA, MRA or
- •Start of EVT (arterial access puncture) possible within the first 6 hours after stroke onset or last seen well
- •EVT with declared first endovascular approach as either stent retriever, aspiration device or a combined approach
- •Written informed consent (after deferred consent)
- •Pre-stroke independent functional status in activities of daily living (mRS=2)
Exclusion Criteria
- •No informed consent
- •Contraindication to EVT or EVT > 6 hours after symptom onset (or last seen well)
- •Evidence of a large core of established infarction defined as ASPECTS 0-4.
- •Evidence of absence/poor collateral circulation on CTA (Tan collateral score of 0 or 1)26.
- •Known co-morbidity with a life expectancy of <6 months prior to acute ischemic stroke
- •Women aged 49 or less or known pregnancy*
- •Cognitive impairment (documented dementia) known prior to ischemic stroke
- •Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2
- •Intent to use any endovascular device other than a stent retriever or clot aspiration device or intra-arterial medications as the initial thrombectomy approach.
- •History of life threatening allergy (more than rash) to contrast medium
- •Evidence of acute hemorrhage on CT, MRI
- •· Significant mass effect with midline shift.
- •· Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
- •· Severe known renal impairment defined as requiring dialysis (hemo- or peritoneal) or if known a eGFR < 20 mL/min.
- •*As 2-IB has not been tested yet for embryonic toxicity and limited pre- and postnatal development studies have been performed, women who can be pregnant must not be included be in this study.
Investigators
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