ThrombX Retriever Post Market Surveillance Study - ThrombX_R

ThrombX Medical, Inc.0 个研究点目标入组 30 人开始时间: 2021年1月20日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Age 18 to 85;
•- Clinical signs consistent with acute anterior circulation ischemic stroke;
•- Pre-stroke Modified Rankin Score = 2;
•- NIHSS = 4 and < 25 immediately prior to enrollment;
•- Imaging shows Alberta Stroke Program early computed tomography (ASPECT) score =6 with computed tomography (CT) scanning or core infarct volume <50mL on magnetic resonance imaging (MRI) or CT based perfusion imaging;
•- Computed tomographic angiography (CTA) or magnetic resonance angiography (MRA) shows an occlusion of the intracranial carotid or the middle cerebral artery M1 division;
•- An appropriate signed and dated informed consent form is obtained from the patient or the patient’s legally designated representative and treating physician

•- Known serious sensitivity to radiographic contrast agents;
•- Known sensitivity to nickel, titanium metals, or their alloys:
•- Renal failure as defined by a serum creatinine > 2·0 mg/dl (or 176·8 µmol/l) or glomerular filtration rate (GFR) < 30 or Subject who requires hemodialysis or peritoneal dialysis;
•- Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol);
•- Baseline platelet count < 50,000/uL;
•- Presumed septic embolus; suspicion of bacterial endocarditis;
•- Contraindication to an angiogram for any reason;
•- Known history of arterial tortuosity, preexisting stent, or other arterial disease that would prevent the device from reaching the target vessel or preclude safe recovery of the device;
•- Presence of carotid dissection;
•- Imaging or clinical evidence of concomitant posterior circulation stroke or acute stroke involving both anterior circulations;
•- CT or MRI evidence of hemorrhage or evidence of mass effect;
•- Imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target lesion, moderate/large infarct with poor collateral circulation)

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