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

Official title

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

Overview

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.

Interventions

• Device Custom-designed tracheobronchial prostheses
  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

Primary outcome measures

• Percentage of procedures with clinical improvement of the dyspnea [Time frame: 12 months]
• Percentage of procedures with clinical improvement of quality of life [Time frame: 12 months]

Secondary outcome measures (4)

• Percentage of procedures with functional improvement [Time frame: 1 seconde]
• Percentage of procedures with congruence of the stent [Time frame: 1 week]
• Percentage of procedures without complications [Time frame: 12 months]
• Percentage of procedures with clinical and functional improvement [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• University Hospital Toulouse — Toulouse

Publications

• Chrissian AA, De Cardenas J, DuComb E, Gesthalter YB, Khosa J, Krumm IR, Channick CL. American Association of Bronchology and Interventional Pulmonology Essential Knowledge in Interventional Pulmonology Series: Selected Topics in Airway Stenting. J Bronchology Interv Pulmonol. 2026 Jan 19;33(2):e1049. doi: 10.1097/LBR.0000000000001049. eCollection 2026 Apr 1. PMID 41550004

Identifiers

NCT: NCT04848025 · RC31/19/0052

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗