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

NCT07191860 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Protocol Number: PR3050
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Primary Safety: defined as Incidence of device- and/or procedure-related Major Adverse Events(MAEs)

  including: * Pneumothorax * Pneumomediastinum * Tracheal or bronchial laceration requiring intervention * Airway perforation or rupture * Required tracheostomy * Bleeding from treatment site consistent with massive hemoptysis defined as \> 100mL of blood expectorated in 24 hours or requiring transfusion * Mediastinitis requiring the need for IV antibiotics and / or hospitalization * Respiratory distress or asphyxia requiring intubation or reintervention * Death

  30 days post index procedure

• Primary Efficacy: freedom from clinically indicated target lesion re-intervention over time

  defined as a therapeutic reintervention/dilation that occurs due to either a recurrence of patient symptoms due to the stenosis and/or a recurrence seen through imaging of the stenosis (≥ 50%) or is an emergent condition related to the stenosis and treatment is required.

  Through the study completion, an average of 1 year

Secondary Outcomes (18)

• Time to first reintervention, defined as duration in days between the index/staged procedure and the first, subsequent procedure for treatment of the target stenosis.

  From Day 1 until the date of first documented reintervention, assessed through the study completion, an average of 1 year.

• Percent change in airway lumen area at 6 months by CT

  Baseline, 6 months

• Change in Peak Expiratory Flow (PEF) from 30 days to 6 months

  1 month, 6 months

• Index procedure success, defined as the ability to deliver study device to the targeted stenosis, inflate, deflate, and remove and with a < 25% residual stenosis.

  On index procedure day 0

• Change in airway lumen volume by CT at follow-up visit

  Baseline, 30 days, 6 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years)

Study Arms (2)

treatment with the Airiver Pulmonary DCB

EXPERIMENTAL

dilate benign stenoses of the airway tree.

Combination Product: The Airiver Pulmonary drug-coated balloon (DCB) dilation

treatment of Commercial airway dilation balloon

ACTIVE COMPARATOR

dilate benign stenoses of the airway tree.

Device: Commercial airway balloon dilation

Interventions

Commercial airway balloon dilation DEVICE

uncoated airway balloon dilation

treatment of Commercial airway dilation balloon

The Airiver Pulmonary drug-coated balloon (DCB) dilation COMBINATION_PRODUCT

drug coated balloon dilation

treatment with the Airiver Pulmonary DCB

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 22 years.
• 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.
• In the opinion of the investigator, subject can undergo laryngoscopy/bronchoscopy under general anesthesia and has a central airway stenosis amenable to balloon dilation.
• For idiopathic subglottic stenoses, either de-novo or a dilation interval equal to or less than 18 months.
• Target benign stenosis etiologies including:
• Post-intubation stenosis,
• Idiopathic subglottic stenosis,
• Post-transplantation stenosis,
• Non-malignant trachea-bronchial stenosis
• Willing and able to complete protocol required follow-up visits.
• Willing and able to provide written informed consent.

You may not qualify if:

• \. Received local steroid or chemotherapeutic treatments into target stenosis in the last 12 weeks or planned treatment during index or staged study procedure.
• \. Planned serial intralesional steroid injections (SILSIs) post index procedure.
• \. 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.
• \. Subject has vasculitis that is not well controlled in the opinion of the investigator.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Airiver Medical, Inc.: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Conditions

Tracheal Stenosis

Interventions

Dilatation

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Alexander Hillel, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Ryan M Kern, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robyn Schacherer, RN

CONTACT

6123108755; schachererr@airiver.com

Mitch Erickson

CONTACT

6518954399; ericksonm@airiver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: September 25, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2030
• Last Updated: March 24, 2026

Record last verified: 2025-12

Locations

US (1)