Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1 Trial)
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Primary efficacy: Freedom from symptom-driven target lesion reintervention (TLR) due to recurrence of stenosis through 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 :
- •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
排除标准
- •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
- •Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure
- •Acute stricture condition that requires emergent procedure (e.g., immediate dilation)
- •Vasculitis that is not well controlled
- •Inability to tolerate bronchoscopy or contraindication to bronchoscopy, anesthesia, or deep sedation
- •Any anatomical limitation of the head and neck, oral cavity or laryngopharynx that may preclude bronchoscopic evaluation or treatment
- •Patient with active pulmonary infection, including but not limited to: COVID-19, influenza, etc.
- •Any disease or condition that interferes with safe completion of the study, such as severe COPD or severe asthma or pulmonary fibrosis.
- •Patients actively being treated with immunosuppressive therapy or with an active immunosuppressed state due to other treatment or underlying disease.
- •Pregnancy or planning on pregnant during the first 12 months of enrollment in the study
- •Life expectancy <1 year
- •Patient is currently enrolled in other investigational studies. Participation in studies for products approved in the US are not considered investigational
研究组 & 干预措施
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).
干预措施: Paclitaxel-Coated Pulmonary Balloon Catheter (Combination Product)
结局指标
主要结局
Primary efficacy: Freedom from symptom-driven target lesion reintervention (TLR) due to recurrence of stenosis through 6 months
时间窗: 6 months
The incidence of subjects free from symptom-driven TLR will be assessed via Kaplan-Meier survival analysis.
Primary safety: Freedom from major adverse device events (MADE) post index procedure through 30 days.
时间窗: 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.
次要结局
- 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)
- Clinical pharmacokinetics of paclitaxel by 10 days(10 days)
- 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)