KCT0008762已完成Unknown
Evaluating the feasibility and safety of an aspiration syringe equipped with a vacuum gauge for aspiration thrombectomy in acute stroke patients with emergent large vessel occlusion: a pilot randomized controlled study
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
Six participants were enrolled, with three in each group. The study was terminated early due to the difficulties of conducting research during emergency care, an unexpected decrease in study participants, and a lack of research funding. The primary outcomes showed that the Synergy aspirator produced similar results to the aspiration pump. For the secondary outcomes, both groups showed overall similar results; however, the Synergy aspirator demonstrated better metrics in device preparation time and user-friendliness as reported by the procedural assistants.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18(Year) 至 79(Year)（—）
- 性别
- All
入选标准
- •1. Aged 18 years or older, and under 80 years of age.
- •2. New focal neurological deficits associated with acute cerebral ischemia. Focal neurological deficits include a decrease in the level of consciousness, gaze palsy, visual field loss, unilateral facial paralysis, weakness in the upper or lower extremities, sensory loss, ataxia, aphasia, dysarthria, neglect, and inattention.
- •3. In cases where patients presenting symptoms as described in item 2 have been examined by the hospital's neurologists, and where the decision to perform an endovascular thrombectomy has been made following discussion with radiologists.
排除标准
- •Clinical Criteria
- •1. Deficiency of blood coagulation factors, known hemorrhagic diathesis or tendency, and receiving anticoagulation therapy with an INR of 3.0 or greater.
- •2. Platelet count less than 50,000/µL in baseline blood tests.
- •3. History or blood lab findings of renal dysfunction (GFR < 30 mL/min).
- •4. Evidence of active systemic infection such as infective endocarditis.
- •5. Cases where femoral artery puncture is not possible.
- •6. A severe allergy to iodinated contrast medium or the presence of contraindications to its use.
- •7. Pregnant women or women with a possibility of pregnancy based on their medical history.
- •8. Cases where the benefits anticipated from the procedure are expected to be limited for other reasons.
- •Radiological Criteria
- •1. Diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage on baseline imaging studies.
- •2. Cases where any hemorrhage cannot be ruled out on baseline imaging studies.
- •3. Angiographic evidence of dissection in the aorta, common carotid artery, internal carotid artery, etc.
- •4. Known or suspected underlying intracranial atherosclerotic lesion that appears related to the target occlusion.
- •5. Tandem occlusion.
- •6. Cases where unstable guide support is strongly anticipated due to excessive vascular tortuosity.
- •7. Evidence of an intracranial tumor.
- •8. Suspected midline shift.
- •9. Cases where the operator deems aspiration thrombectomy inappropriate considering baseline imaging findings such as tortuosity.
- •10. Cases where the operator deems that the procedure risk is increased due to other radiological findings.
研究者
相似试验
已完成
不适用
A two-part parallel group study to assess the safety, tolerability and pharmacokinetic (PK) profile of multiple oral doses of RDN-929 in healthy older adults and subjects with early symptomatic Alzheimer*s Diseaseneurodegenerative diseasesAlzheimer's DiseaseNL-OMON48424Rodin Therapeutics, Inc.45
已完成
2 期
Efficacy and safety of weekly nab-paclitaxel plus CBDCA in patients with CUPcancer of unknown primaryCUP, nab-Paclitaxel,CBDCAJPRN-jRCTs051180084Yagi Toshinari17
已完成
不适用
A 3-part study to investigate the safety, pharmacodynamics and pharmacokinetics of increasing doses of intravenously administered N,N-dimethyltryptamine (DMT) and deuterated DMT (CYB004) in healthy smokers and non-smokersSubstance use disorders: Tobacco and Nicotine Addictionnicotine dependencesmoking10027946NL-OMON54291Cybin IRL Limited74
已完成
不适用
A prospective, multicenter clinical study to evaluate the safety profile of the FlexiSurge Adhesion Barrier for the prevention of intra-abdominal adhesion formation after laparotomyvorming van adhesies na buikchirurgieadhesion formationpostoperative adhesionsNL-OMON40303Medisse BV5
已完成
2 期
A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndromePWSNL-OMON48225Millendo Therapeutics SAS23