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

Официальное название

A Randomized, Controlled, Multi-Center, Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis (OXYGEN-RCT Trial)

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт The Airiver Pulmonary drug-coated balloon (DCB) dilation
  drug coated balloon dilation
• Устройство Commercial airway balloon dilation
  uncoated airway balloon dilation

Первичные конечные точки

• Primary Safety: defined as Incidence of device- and/or procedure-related Major Adverse Events(MAEs) [Срок оценки: 30 days post index procedure]
• Primary Efficacy: freedom from clinically indicated target lesion re-intervention over time [Срок оценки: Through the study completion, an average of 1 year]

Вторичные конечные точки (12)

• 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. [Срок оценки: 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 [Срок оценки: Baseline, 6 months]
• Change in Peak Expiratory Flow (PEF) from 30 days to 6 months [Срок оценки: 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. [Срок оценки: On index procedure day 0]
• Change in airway lumen volume by CT at follow-up visit [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline, 3 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years).]

Критерии участия

Критерии включения

• 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.

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.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Johns Hopkins University — Baltimore

Идентификаторы

NCT: NCT07191860 · Protocol Number: PR3050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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