About this trial
The placement of an endoprosthesis in the airways leads to rapid and dramatic clinical improvement in the majority of cases of central airway obstruction. However, the limited diversity of device shapes available on the market is a major limitation, as these devices are poorly adapted, or not adapted at all, to the patient's anatomy. The main consequences of this lack of congruity are stent migration and granulomatous inflammatory reactions. The investigators hypothesized that personalized endoprostheses could significantly reduce the complication rate and improve tolerability. In this randomized controlled trial, the investigators propose to evaluate whether personalized endoprostheses allow for better management of non-malignant central airway stenoses by comparing this new approach to standard care.
Eligibility criteria
Qualifiers
Age >18 years,
Central non-malignant symptomatic (dyspnea > grade 2 mMRC or post-stenotic infection) airway stenosis with silicone stent implantation indication (viable downstream airways, pulmonary artery and parenchyma),
To have access to a personal telephone for the teleconsultation scheduled in the protocol,
Informed consent signed,
Disqualifiers
Acute respiratory distress,
Mechanical ventilation,
Contraindication to rigid bronchoscopy: severe coagulation disorders that cannot be corrected, anticoagulant or antiplatelet therapy other than aspirin within 5 days prior to the stent implantation,
Malignant stenosis,
Trial design
Treatments tested in this trial
- Informed consent
- Eligibility criteria check
- Randomisation
- Dyspnea-12 questionnaire
- VQ11 questionnaire
- EQ-5D-5L questionnaire
- Spirometry
- Chest CT scan
- Commercially Stent Implantation
- Experimental Stent Implantation
Treatment groups
Sponsors and collaborators
University Hospital, Toulouse
Lead sponsor
novatech
Collaborator