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

NCT05895305 | Active Not Recruiting Early Phase 1

• 1 other identifier: Oxygen-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1) is to evaluate clinical safety and potential efficacy of the Airiver Pulmonary DCB in the treatment of benign central airway stenosis.

Conditions

Central Airway Obstruction

Keywords

benign; central airway obstruction; drug coated balloon

Outcome Measures

Primary Outcomes (2)

• Primary safety: Freedom from major adverse device events (MADE) post index procedure through 30 days.

  MADE is defined as: * Airway perforation (Pneumothorax) * Pneumomediastinum * Massive bleeding * Mediastinitis requiring the need for IV antibiotics and / or hospitalization * Respiratory distress or asphyxia requiring intubation or reintervention * Evidence of negative local tissue reaction to paclitaxel Subjects failing any component of the primary safety endpoint will be considered a safety failure, and subjects who remain event free through 30 days will be considered safety successes. Primary safety will be assessed as the proportion of subjects free from the primary safety event.

  30 days

• Primary efficacy: Freedom from symptom-driven target lesion reintervention (TLR) due to recurrence of stenosis through 6 months

  The incidence of subjects free from symptom-driven TLR will be assessed via Kaplan-Meier survival analysis.

  6 months

Secondary Outcomes (6)

• Incidence of, and time to, symptom-driven target lesion reintervention through 12 months.

  12 months

• Bronchoscopic target lesion patency (Myer-Cotton airway grading system) change through 12 months.

  12 months

• Spirometry (FEV1) change through 12 months

  12 months

• mMRC (Modified Medical Research Council) dyspnea scale change through 12 months

  12 months.

• Quality of life (QOL) change: Patient report outcomes (SF-12) through 12 months

  12 months

Study Arms (1)

Single arm treated by Airiver Pulmonary DCB

EXPERIMENTAL

subject will be treated by Airiver Pulmonary Drug Coated Balloon (DCB) catheter. The balloon is coated with a paclitaxel drug (3.5ug/mm2).

Combination Product: Paclitaxel-Coated Pulmonary Balloon Catheter

Interventions

Paclitaxel-Coated Pulmonary Balloon Catheter COMBINATION_PRODUCT

Subjects with benign airway stenosis will be treated by Airiver pulmonary DCB at index procedure

Also known as: DCB

Single arm treated by Airiver Pulmonary DCB

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged ≥18 old
• Symptomatic, severe (\> 50%) benign CAO (by CT or bronchoscopy)
• Stenosis is distal to cricoid and proximal to segmental bronchi
• Indicated for balloon dilation only or as an adjunct to standard of care
• 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

You may not qualify if:

• Malignant CAO
• Dynamic etiology of benign stenosis such as excessive dynamic airway collapse, tracheobronchomalacia, or stenosis due to external compression
• Presence of a known perforation at the site of proposed dilation
• Presence of a known fistula between the tracheobronchial tree and esophagus, mediastinum to pleural space
• Obstruction not amenable to bronchoscopic dilation in the opinion of the investigator
• Allergy to paclitaxel or structurally related compounds
• Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure
• Acute stricture condition that requires emergent procedure (e.g., immediate dilation)
• Vasculitis that is not well controlled
• Inability to tolerate bronchoscopy or contraindication to bronchoscopy, anesthesia, or deep sedation
• Any anatomical limitation of the head and neck, oral cavity or laryngopharynx that may preclude bronchoscopic evaluation or treatment
• Patient with active pulmonary infection, including but not limited to: COVID-19, influenza, etc.
• Any disease or condition that interferes with safe completion of the study, such as severe COPD or severe asthma or pulmonary fibrosis.
• Patients actively being treated with immunosuppressive therapy or with an active immunosuppressed state due to other treatment or underlying disease.
• Pregnancy or planning on pregnant during the first 12 months of enrollment in the study

Sponsors & Collaborators

• Airiver Medical, Inc.: lead
• Libra Medical: collaborator

Study Sites (1)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

Study Officials

• Kakha Vacharadze, MD

  National Center for Tuberculosis and Lung Diseases, Tbilisi State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 8, 2023
• Study Start: May 16, 2023
• Primary Completion: October 4, 2025
• Study Completion (Estimated): October 4, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

GE (1)