Management of Complex Airway Stenoses With Dedicated Tailored Stents Wrought by 3D Computer-assisted Conception

NCT02889029 | Completed DMC

• 1 other identifier: RC31/15/7860
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Management of complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted conception Dedicated Airway Stents for Central Airway Stenoses DASCAS 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 conception 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.

Conditions

Obstructive Airway Disease

Outcome Measures

Primary Outcomes (1)

• Change of percentage of procedures conducted without complications at 1 week , 3 months and 6 months

  percentages of procedures conducted without complication at 1 week, 3 months and 6 month and their confidence interval at 95% and incidences at 1 week, 3 months and 6 months for each complication will be calculated.

  Change of percentage of procedures conducted without complications at 1 week, 3 months and 6 months

Study Arms (1)

new 3D device

EXPERIMENTAL

dedicated tailored stents wrought by 3D computer-assisted conception

Device: new 3D device

Interventions

new 3D device DEVICE

dedicated tailored stents wrought by 3D computer-assisted conception

new 3D device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Signature of the informed consent form
• Patient with a complex upper airway stenosis .
• Symptomatic stenosis ( Dyspnea \> NYHA II , cough, PEF \< 50%)
• Stenosis whose complex anatomy does not allow the establishment of a currently available stent on the market: the assessment of the experts ( consensus decision between 3 bronchoscopistes of interventional endoscopy service) or after failure of one or several models.
• Affiliated with a social security scheme

You may not qualify if:

• Indication of implementation of emergency aid : signs of acute respiratory distress , PEF \< 20 % predicted , SpO2 oxygen saturation \<90 % on room air
• Contraindication to rigid bronchoscopy (severe coagulation disorders not correct )
• Patient under legal protection system
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Related Publications (1)

• Guibert N, Didier A, Moreno B, Lepage B, Leyx P, Plat G, Mhanna L, Murris M, Mazieres J, Hermant C. Treatment of complex airway stenoses using patient-specific 3D-engineered stents: a proof-of-concept study. Thorax. 2019 Aug;74(8):810-813. doi: 10.1136/thoraxjnl-2018-212732. Epub 2019 Apr 3.

  PMID: 30944151 RESULT

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nicolas Guibert, Dr

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: September 5, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: November 1, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share