Airiver Medical, Inc.
The OXYGEN-RCT trial is a randomized, controlled, double blinded, prospective, multi-center trial to demonstrate the safety and efficacy in adult benign central airway stenosis. Participates will be in a 1:1 allocation to treatment with the Airiver Pulmonary DCB or standard of care laryngoscopic/bronchoscopic balloon dilation, respectively.
Subjects will complete follow-up post-treatment at 30 days, 3 months, 6 months, 12 months, and every 6 months after through the primary endpoint, with a minimum of 2 years at study end.
Inclusion Criteria: 1. Age ≥ 22 years. 2. Symptomatic de-novo or restenotic benign central airway stenosis in the subglottis, trachea, or mainstem bronchi with at least 50% narrowing, as determined by CT or bronchoscopy. 3. In the opinion of the investigator, subject can undergo laryngoscopy/bronchoscopy under general anesthesia and has a central airway stenosis amenable to balloon dilation. 4. For idiopathic subglottic stenoses, either de-novo or a dilation interval equal to or less than 18 months. 5. Target benign stenosis etiologies including: 1. Post-intubation stenosis, 2. Idiopat…
drug coated balloon dilation
uncoated airway balloon dilation
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