Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion
Serious perioperative complications affecting subsequent hyperbaric oxygen therapy (such as cerebral hemorrhage, disabling stroke, etc.)
Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 12 months
Hemorrhagic transformation after ischemic stroke within 60 days before enrollment
Trial design
Treatments tested in this trial
- Hyperbaric oxygen therapy
- Standard medical treatment
- Risk factor management
Treatment groups
90 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov