Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1 Trial)
Sponsor study identifier
interventional
45
1 country
1
Study Start
May 16, 2023
Actual (reported)Primary Completion
October 4, 2025
Actual (reported)Study Completion
October 4, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 4, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 16, 2023
Actual (reported)May 31, 2023
Actual (reported)June 8, 2023
Actual (reported)October 4, 2025
Actual (reported)October 4, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
subject will be treated by Airiver Pulmonary Drug Coated Balloon (DCB) catheter. The balloon is coated with a paclitaxel drug (3.5ug/mm2).
Subjects with benign airway stenosis will be treated by Airiver pulmonary DCB at index procedure
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, 0112, Georgia
Kakha Vacharadze, MD
National Center for Tuberculosis and Lung Diseases, Tbilisi State Medical University
45 participants (actual enrollment reported by the registry).
First Submitted
May 31, 2023
First Posted
June 8, 2023
Study Start
May 16, 2023
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
October 4, 2025
Actual (reported)Study Completion
October 4, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 15, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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