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 - IBIS

Haaglanden Medisch Centrum0 个研究点目标入组 36 人开始时间: 2022年2月5日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•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 DSA
•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
•Pre-stroke independent functional status in activities of daily living (mRS =2)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 36
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 36

•Contraindication to EVT or EVT > 6 hours after symptom onset (or last seen well)
•No informed consent
•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.

发起方