Management of complex airway stenoses with dedicated tailored stents wrought by 3D
Dedicated Airway Stents for Central Airway Stenoses
Toulouse University Hospital is the sponsor of this research.
This research will be conducted with the support of AnatomikModeling and ADERSPOT
- Background: Tracheobronchial stent are devices designed to manage central airway
stenoses of various origins. Their shape and sizes are however not suitable for stenosis
of complex anatomy.
- Purpose: The investigators propose to test the feasibility and safety of treating
complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted
Abstract: Central airway obstruction is currently managed with non-personalized stents, which
are usually efficient but lead to severe and potentially lethal complications in 10% of cases
(stent migration, obstructive granuloma, perforation, hemoptysis). These stents seem
particularly unsuited for anatomically complex stenosis.
Dedicated airway stents (wrought and tailored by 3D computer-assisted conception based on 3D
chest CT-scan), by fitting perfectly tracheal or bronchial anatomy, should dramatically
improve the tolerance and safety of such prostheses.
This first feasibility study, dedicated to patients suffering from anatomically complex
stenosis will test the safety of treating patients with these new approach. It should lead to
larger studies evaluating these new types of stents in larger indications.
After 3D computer-assisted modelization of airways, a virtual prosthesis and its shape are
designed and the shape of the stent is wrought by 3D-machining by AnatomikModeling®. The
stent is then build and sterilized by Sebbin® and inserted during rigid bronchoscopy on the
same terms as pre-existing models.
Close follow up is then conducted, including clinical evaluation after one week, three and
six months; spirometry at one week and 6 months and chest CT-scan at one week.