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

NCT ID: NCT07191860

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2030-11-01

Brief Summary

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.

Detailed Description

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.

Conditions

Adult Subjects With Symptomatic Benign Airway Obstruction; Adult Benign Central Airway Stenosis; Adult Tracheobronchial Stenosis; Tracheal Stenosis; Central Airway Stenosis; Central Airway Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

treatment with the Airiver Pulmonary DCB

dilate benign stenoses of the airway tree.

Group Type: EXPERIMENTAL

The Airiver Pulmonary drug-coated balloon (DCB) dilation

Intervention Type: COMBINATION_PRODUCT

drug coated balloon dilation

treatment of Commercial airway dilation balloon

dilate benign stenoses of the airway tree.

Group Type: ACTIVE_COMPARATOR

Commercial airway balloon dilation

Intervention Type: DEVICE

uncoated airway balloon dilation

Interventions

The Airiver Pulmonary drug-coated balloon (DCB) dilation

drug coated balloon dilation

Intervention Type: COMBINATION_PRODUCT

Commercial airway balloon dilation

uncoated airway balloon dilation

Intervention Type: DEVICE

Eligibility Criteria

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. Idiopathic subglottic stenosis,

3. Post-transplantation stenosis,

4. Non-malignant trachea-bronchial stenosis

6. Willing and able to complete protocol required follow-up visits.

7. Willing and able to provide written informed consent.

Exclusion Criteria

4. Subject has existing tracheostomy or had a tracheostomy within past 90 days 5. Contraindication to laryngoscopy/bronchoscopy, anesthesia, or deep sedation 6. Planned tracheal resection in the next 90 days. 7. Dynamic etiology of benign stenosis such as excessive dynamic airway collapse, tracheobronchomalacia, or stenosis due to external compression, or past tracheostomy which requires stent placement or surgical referral 8. Inclusion of vocal cord in target stenosis 9. Known medically significant unresolved lower respiratory tract infection, such as pneumonia, fungus, tuberculosis, etc.unrelated to stenosis 10. Target stenosis is beyond the mainstem bronchi 11. Signs or suspicion of a malignant airway obstruction NOTE: If obstruction is suspicious for malignancy based on clinical or laryngoscopic/bronchoscopic presentation, malignancy must be excluded by biopsy prior to randomization 12. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure 13. Chronic steroid use exceeding more than 10 mg per day for any medical condition including immunosuppression post-lung transplant or autoimmune associated airway suppression.

14. Received local steroid or chemotherapeutic treatments into target stenosis in the last 12 weeks or planned treatment during index or staged study procedure.

15. Planned serial intralesional steroid injections (SILSIs) post index procedure.

16. Stenosis not amenable to laryngoscopic/bronchoscopic dilation in the opinion of the investigator 17. Acute condition that requires emergent procedure prior to screening assessment 18. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, ongoing infection, etc 19. Subject has known fistula between tracheobronchial tree and esophagus, mediastinum to pleural space.

20. Subject has vasculitis that is not well controlled in the opinion of the investigator.

21. Diagnosed with a disease requiring chemotherapy (e.g. cancer). 22. Allergy to paclitaxel or structurally related compounds 23. Target stenosis is within a transplanted lung or transplant anastomosis, or a tracheal resection anastomosis, which has been transplanted or resected within the last 60 days.

24. Target stenosis is related to radiation therapy 25. Subject has a life expectancy of less than 2 years. 26. Current participation in another pre-market drug or medical device clinical study that has not reached its primary endpoint.

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• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Airiver Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Hillel, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Ryan M Kern, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Central Contacts

Robyn Schacherer, RN

Role: CONTACT

schachererr@airiver.com

6123108755

Mitch Erickson

Role: CONTACT

ericksonm@airiver.com

6518954399

Other Identifiers

Protocol Number: PR3050

Identifier Type: -

Identifier Source: org_study_id