Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial (NCT05980195) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial
90 participantsStarted 2024-07-16
Plain-language summary
The purpose of CARE-HBOT study is to evaluate whether patients with symptomatic severe carotid artery stenosis with cognitive impairment who underwent hyperbaric oxygen therapy plus standard medical treatment after stent implantation could improve their cognitive function compared with those who underwent standard postoperative medical treatment.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age from 18 to 75 years
✓. National Institute of Health stroke scale (NIHSS) ≤3
✓. Culprit vessel was the common carotid artery or extracranial internal carotid artery, involving or not involving the external carotid artery
✓. The degree of culprit arterial stenosis is 70-99 % ; based on Digital subtraction angiography (DSA) (According to North American Symptomatic Carotid Endarterectomy Trial (NASCET) method)
✓. The diameter of the target vessel between 4.0 mm - 9.0 mm
✓. Mini-mental State Examination (MMSE) score : education level-middle school ≤ 24; education level-high school ≤ 20 ; education level-college ≤ 17
. Hemorrhagic transformation after ischemic stroke within 60 days before enrollment
✕. Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, Moyamoya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected vasospasm, suspicious embolism recanalization, etc
✕. Nervous system diseases in the past two years, characterized by transient or fixed neurological deficits (such as partial or secondary generalized seizures of epilepsy, complex or classic migraine, tumor or other intracranial space-occupying lesions, subdural hematoma, brain contusion or other post-traumatic lesions, intracranial infection, demyelinating diseases, intracranial hemorrhage, etc.), which cannot be distinguished from cerebral infarction
✕. History of stenting of an intracranial or extracranial artery
✕. Presence of any unequivocal cardiac source of embolism