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

NCT ID: NCT05895305

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2029-10-04

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.

Detailed Description

Benign central airway stenosis/obstruction, including stenosis of the subglottic area, trachea, and bronchi, is related to significant morbidity due to dyspnea and impaired quality of life. It is hypothesized that Airiver pulmonary drug-coated balloon (DCB) will improve patient outcome in the bronchoscopic treatment of benign airway obstruction, and, as an adjunct to standard of care, will prolong airway patency compared to the standard of care alone. This is a prospective, multi-center, single-arm, open-label, safety & feasibility, OUS first in human study for safety and potential efficacy.

Conditions

Central Airway Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm treated by Airiver Pulmonary DCB

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

Group Type: EXPERIMENTAL

Paclitaxel-Coated Pulmonary Balloon Catheter

Intervention Type: COMBINATION_PRODUCT

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

Interventions

Paclitaxel-Coated Pulmonary Balloon Catheter

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

DCB

Eligibility Criteria

Inclusion Criteria

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged ≥18 old

4. Symptomatic, severe (> 50%) benign CAO (by CT or bronchoscopy)

1. Stenosis is distal to cricoid and proximal to segmental bronchi

2. Indicated for balloon dilation only or as an adjunct to standard of care

3. 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 antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure

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, or deep sedation

11. Any anatomical limitation of the head and neck, oral cavity or laryngopharynx that may preclude 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 as severe COPD or severe asthma or pulmonary fibrosis.

14. Patients actively being treated with immunosuppressive therapy or with an active immunosuppressed state due to other treatment or underlying disease.

15. Pregnancy or planning on pregnant during the first 12 months of enrollment in the study

16. Life expectancy <1 year

17. Patient is currently enrolled in other investigational studies. Participation in studies for products approved in the US are not considered investigational

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Libra Medical

OTHER

Sponsor Role: collaborator

Airiver Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kakha Vacharadze, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, , Georgia

Countries

Georgia

Other Identifiers

Oxygen-1

Identifier Type: -

Identifier Source: org_study_id