Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for theduration of the study
3. Male or female, aged ≥18 old
4. Symptomatic, severe (> 50%) benign CAO (by CT or bronchoscopy)
5. Stenosis is distal to cricoid and proximal to segmental bronchi
6. Indicated for balloon dilation only or as an adjunct to standard of care
7. Includes, but not limited to :

• Post intubation tracheal stenosis (PITS)
• Post tracheostomy tracheal stenosis (PTTS)
• Post lung transplantation stenosis
• Stenosis related to airway stent
• Subglottic stenosis (SGS)
• Stenosis due to tuberculosis

Exclusion Criteria:

1. Malignant CAO
2. Dynamic etiology of benign stenosis such as excessive dynamic airway collapse,tracheobronchomalacia, or stenosis due to external compression
3. Presence of a known perforation at the site of proposed dilation
4. Presence of a known fistula between the tracheobronchial tree and esophagus,mediastinum to pleural space
5. Obstruction not amenable to bronchoscopic dilation in the opinion of the investigator
6. Allergy to paclitaxel or structurally related compounds
7. Severe coagulation disorders or current use of anticoagulant or antiplateletmedication that cannot be safely managed per recommended guidelines prior to the indexprocedure
8. Acute stricture condition that requires emergent procedure (e.g., immediate dilation)
9. Vasculitis that is not well controlled
10. Inability to tolerate bronchoscopy or contraindication to bronchoscopy, anesthesia, ordeep sedation
11. Any anatomical limitation of the head and neck, oral cavity or laryngopharynx that maypreclude bronchoscopic evaluation or treatment
12. Patient with active pulmonary infection, including but not limited to: COVID-19,influenza, etc.
13. Any disease or condition that interferes with safe completion of the study, such assevere COPD or severe asthma or pulmonary fibrosis.
14. Patients actively being treated with immunosuppressive therapy or with an activeimmunosuppressed state due to other treatment or underlying disease.
15. Pregnancy or planning on pregnant during the first 12 months of enrollment in thestudy
16. Life expectancy <1 year
17. Patient is currently enrolled in other investigational studies. Participation instudies for products approved in the US are not considered investigational