Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis (NCT05895305) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis
Georgia45 participantsStarted 2023-05-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 :
Exclusion criteria
✕. 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
✕
What they're measuring
1
Primary safety: Freedom from major adverse device events (MADE) post index procedure through 30 days.
Timeframe: 30 days
2
Primary efficacy: Freedom from symptom-driven target lesion reintervention (TLR) due to recurrence of stenosis through 6 months
. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure