NCT07191860招募中不适用
A Randomized, Controlled, Multi-Center, Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis (OXYGEN-RCT Trial)
Airiver Medical, Inc.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年2月24日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Primary Efficacy: freedom from clinically indicated target lesion re-intervention over time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 22 years.
- •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.
- •In the opinion of the investigator, subject can undergo laryngoscopy/bronchoscopy under general anesthesia and has a central airway stenosis amenable to balloon dilation.
- •For idiopathic subglottic stenoses, either de-novo or a dilation interval equal to or less than 18 months.
- •Target benign stenosis etiologies including:
- •Post-intubation stenosis,
- •Idiopathic subglottic stenosis,
- •Post-transplantation stenosis,
- •Non-malignant trachea-bronchial stenosis
- •Willing and able to complete protocol required follow-up visits.
- •Willing and able to provide written informed consent.
排除标准
- •Two or more clinically significant (e.g. non-traversable) stenoses with total length >5cm or unable to be treated with a single balloon
- •Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months
- •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
- •Contraindication to laryngoscopy/bronchoscopy, anesthesia, or deep sedation
- •Planned tracheal resection in the next 90 days.
- •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
- •Inclusion of vocal cord in target stenosis
- •Known medically significant unresolved lower respiratory tract infection, such as pneumonia, fungus, tuberculosis, etc.unrelated to stenosis
- •Target stenosis is beyond the mainstem bronchi
- •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
- •Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure
- •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
- •Acute condition that requires emergent procedure prior to screening assessment
- •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
- •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).
- •Allergy to paclitaxel or structurally related compounds
- •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
- •Subject has a life expectancy of less than 2 years.
- •Current participation in another pre-market drug or medical device clinical study that has not reached its primary endpoint.
研究组 & 干预措施
treatment with the Airiver Pulmonary DCB
Experimental
dilate benign stenoses of the airway tree.
干预措施: The Airiver Pulmonary drug-coated balloon (DCB) dilation (Combination Product)
treatment of Commercial airway dilation balloon
Active Comparator
dilate benign stenoses of the airway tree.
干预措施: Commercial airway balloon dilation (Device)
结局指标
主要结局
Primary Efficacy: freedom from clinically indicated target lesion re-intervention over time
时间窗: Through the study completion, an average of 1 year
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.
Primary Safety: defined as Incidence of device- and/or procedure-related Major Adverse Events(MAEs)
时间窗: 30 days post index procedure
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
次要结局
- 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.(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(Baseline, 6 months)
- Change in Peak Expiratory Flow (PEF) from 30 days to 6 months(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.(On index procedure day 0)
- Secondary patency, defined as freedom from reintervention after a first reintervention, at each follow-up(From the date of the first reintervention to the next follow-up visit through the study completion, an average of 1 year.)
- Change in airway lumen volume by CT at follow-up visit(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(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 peak expiratory flow (PEF)(Baseline, 3 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years).)
- Annualized rate, of reinterventions(Assessed annually through the date of the study complete, an average of 1 year.)
- Change in forced expiratory volume in 1 second (FEV1) at follow-up visit(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(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))
- Change in expiratory disproportion index (EDI)(Baseline, 30 days, 3 months, 6 months, 12 months, then every 6month until the date of the study complete (assessed up to 2 years))
- Changes in the ratio of FVE1 and FVC at follow-up visit(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))
- Rate of cannulation, stent, or open surgery due to target lesion stenosis(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(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(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(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(Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the study completion (assessed up to 2 years))
研究者
研究点 (1)
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