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

N/ANot Yet RecruitingNCT07191860

Airiver Medical, Inc.200 enrolled

Overview

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.

Subjects will complete follow-up post-treatment at 30 days, 3 months, 6 months, 12 months, and every 6 months after through the primary endpoint, with a minimum of 2 years at study end.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

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

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 22 years. 2. 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. 3. In the opinion of the investigator, subject can undergo laryngoscopy/bronchoscopy under general anesthesia and has a central airway stenosis amenable to balloon dilation. 4. For idiopathic subglottic stenoses, either de-novo or a dilation interval equal to or less than 18 months. 5. Target benign stenosis etiologies including: 1. Post-intubation stenosis, 2. Idiopathic subglottic stenosis, 3. Post-transplantation stenosis, 4. Non-malignant trachea-bronchial stenosis 6. Willing and able to complete protocol required follow-up visits. 7. Willing and able to provide written informed consent. Exclusion Criteria:1. Two or more clinically significant (e.g. non-traversable) stenoses with total length \>5cm or unable to be treated with a single balloon 2. Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months 3. Subject currently has a stent at target stenosis location or has had a stent at the target location within the past 90 days. 4\. Subject has existing tracheostomy or had a tracheostomy within past 90 days 5. Contraindication to laryngoscopy/bronchoscopy, anesthesia, or deep sedation 6. Planned tracheal resection in the next 90 days. 7. Dynamic etiology of benign stenosis such as excessive dynamic airway collapse, tracheobronchomalacia, or stenosis due to external compression, or past tracheostomy which requires stent placement or surgical referral 8. Inclusion of vocal cord in target stenosis 9. Known medically significant unresolved lower respiratory tract infection, such as pneumonia, fungus, tuberculosis, etc.unrelated to stenosis 10. Target stenosis is beyond the mainstem bronchi 11. Signs or suspicion of a malignant airway obstruction NOTE: If obstruction is suspicious for malignancy based on clinical or laryngoscopic/bronchoscopic presentation, malignancy must be excluded by biopsy prior to randomization 12. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure 13. Chronic steroid use exceeding more than 10 mg per day for any medical condition including immunosuppression post-lung transplant or autoimmune associated airway suppression. 14\. Received local steroid or chemotherapeutic treatments into target stenosis in the last 12 weeks or planned treatment during index or staged study procedure. 15\. Planned serial intralesional steroid injections (SILSIs) post index procedure. 16\. 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. 20\. Subject has vasculitis that is not well controlled in the opinion of the investigator. 21\. 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. 24\. 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. \-

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: Through the study completion, an average of 1 year

Secondary Outcomes

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.

Hypothesis-test

Time frame: 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

Hypothesis-test. The percent change expressed as the airway lumen volume within the treated segment at 6 months (Area 6mo), compared to the personal baseline airway lumen volume (AreaBL) on CT scan. Percent change in airway luminal area = (Area6mo - AreaBL) / AreaBL ×100%

Time frame: Baseline, 6 months

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

Hypothesis-test. PEF in L/min

Time frame: 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.

Non-hypothesis test. NO device malfunction issues. Use visual estimation under bronchoscopy at the end of index procedure, compare post-treated airway diameter (TD, mm) versus airway native diameter (ND, mm), residual stenosis = (ND- TD)/NDx100%

Time frame: On index procedure day 0

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

Non-hypothesis test. Change in lumen volume in percentage (%). The percent change expressed as the airway lumen volume within the treated segment at follow-up (AreaFU) compared to the personal baseline airway lumen volume (AreaBL) on CT scan. Percent change in airway luminal area = (AreaFU - AreaBL) / AreaBL ×100%

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

Freedom from reintervention, defined as any reintervention on the target stenosis, whether clinically indicated or not

Non-hypothesis test

Time frame: 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study complete (assessed up to 2 years)

Annualized rate, of reinterventions

Non-hypothesis test

Time frame: Assessed annually through the date of the study complete, an average of 1 year.

Secondary patency, defined as freedom from reintervention after a first reintervention, at each follow-up

Non-hypothesis test

Time frame: From the date of the first reintervention to the next follow-up visit through the study completion, an average of 1 year.

Change in forced expiratory volume in 1 second (FEV1) at follow-up visit

Non-hypothesis test. FEV1 in liters

Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date for the study complete (assessed up to 2 years)

Change in forced vital capacity (FVC) at follow-up visit

Non-hypnoses test. FVC in liters

Time frame: Baseline, 30 day, 3 months, 6 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years)

Changes in the ratio of FVE1 and FVC at follow-up visit

Non-hypnoses test. The Ratio =(FVE1/FVC) x100%

Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years)

Change in peak expiratory flow (PEF)

Non-hypnoses test. PEF in liters per minute (L/min)

Time frame: Baseline, 3 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years).

Change in expiratory disproportion index (EDI)

Non-hypnoses test. EDI= (FEV1/PEF) x100%

Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6month until the date of the study complete (assessed up to 2 years)

Rate of cannulation, stent, or open surgery due to target lesion stenosis

Non-hypothesis test

Time frame: 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study complete (assessed up to 2 years)

Change in modified Medical Research Council (mMRC) Dyspnea Scale

Non-hypothesis test. mMRC is a self-assessment tool and rated on a scale from 0 to 4, where a higher score means a worse outcome.

Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study completion (assessed up to 2 years)

Change in Chronic Obstructive Pulmonary Disease (COPD) Questionnaire

Non-hypnoses test. The questionnaire is rated on 0-6 scale, a higher score indicating a worse health status.

Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study completion (assessed up to 2 years)

Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score

Non-hypnosis test. SF-12 is a self-reported outcome and rated on a 0-5 scale, where a higher score indicates better health.

Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of the study completion (assessed up to 2 years)

Change in Voice Handicap Index (VHI-10) questionnaire

Non-hypnosis test. VHI-10 is a self-administered questionnaire and scored from 0 to 4, where a higher score indicates a greater voice -related handicap.

Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the study completion (assessed up to 2 years)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts