Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM

Study Overview
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Brief Summary
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Airway stenting is usually efficient to treat central airway obstruction but can lead to severe and potentially lethal complications (stent migration, obstructive granuloma, perforation, and hemoptysis). 3D customized airway stents (computer-aided conception using CT-scan data), perfectly suited to airway anatomy, should improve the tolerance and safety of airway stenting. We demonstrated in a previous pilot study, dedicated to patients with anatomically complex stenoses the safety of 3D patient-specific stents. These appealing results in highly complex situations suggest the need to evaluate these devices in more common situations. In this study we aim to test our new generation stents in all patients planned for airway stenting. After computer-assisted segmentation of airways (VGStudioMAX 3.0 software), the stenosis is virtually corrected, leading to the conception of a virtual stent (AnatomikModeling, Toulouse), allowing for the fabrication of a mold using a 3D printer. The stent is then built and sterilized (NOVATECH, Berlin) and inserted during rigid bronchoscopy. Close follow up is then conducted, including clinical evaluation after one week, three, six and 12 months; spirometry at one week, 3 months, 6 months and 12 months and chest CT-scan at one week.

Official Title
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Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM (Three-dimensional Airway Tailored Stent Using Computer-aided Modeling)

Conditions
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Airway Disease

Intervention / Treatment
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* Device: Custom-designed tracheobronchial prostheses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Informed consent Complex, proximal and symptomatic (dyspnea, cough, peak flow < 50%, FEV1 < 50% or post-stenotic infection) airway stenosis Exclusion Criteria: Acute respiratory distress, mechanical ventilation Contraindication to rigid bronchoscopy (severe and irreversible coagulation disorders) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D customized airway stents<br> | Device: Custom-designed tracheobronchial prostheses<br>* Computer-assisted segmentation of airways and stent from CT data (AnatomikModeling) Fabrication of a mold and then a silicon stent by mold injection and sterilization (NOVATECH) Insertion of the stent under rigid bronchoscopy and general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of procedures with clinical improvement of the dyspnea | Percentage of procedures with clinical improvement of the dyspnea with questionnaires of Borg, modified Medical Research Council (mMRC), and Dyspnea 12 | 12 months | 
| Percentage of procedures with clinical improvement of quality of life | Percentage of procedures with clinical improvement of quality of life with the VQ11 questionnaire | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of procedures with functional improvement | Percentage of procedures with functional improvement ( forced expiratory volume in one second (FEV1)) | 1 seconde | 
| Percentage of procedures with congruence of the stent | Percentage of procedures with congruence of the stent with tracheobronchial anatomy on CT-scan at 1 week | 1 week | 
| Percentage of procedures without complications | Percentage of procedures without complications at 1 week, 3 months, 6 months and 12 months (stent migration, obstructive granuloma, perforation, hemoptysis). | 12 months | 
| Percentage of procedures with clinical and functional improvement | Percentage of procedures with clinical (dyspnea, cough, quality of life (VQ11 questionnaire)), and functional improvement (peak flow, forced expiratory volume in one second (FEV1)) at 3 months, 6 months and 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rigid bronchoscopy, 3D computer-assisted fabrication, silicon-dedicated stent