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RecruitingNCT06935110Updated Jun 12, 2026

Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch

An interventional study of Cryopreserved aortic patch in Trachea Diseases, Airway Remodeling and Reconstruction Surgery, sponsored by National Taiwan University Hospital. Recruiting at 2 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.

02

Conditions studied

  • Trachea Diseases
  • Airway Remodeling
  • Reconstruction Surgery

Keywords

  • cryopreserved aortic patch
  • airway repair
  • tracheal reconstruction
  • bronchial reconstruction
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Congenital tracheal deformities: Includes congenital tracheomalacia, congenital tracheobronchial malformations, complete tracheal rings, etc., with severe clinical symptoms and cases where treatment is recommended after evaluation.
  2. Acquired tracheal stenosis: Includes tracheal narrowing caused by diseases, endotracheal intubation, or postoperative scar tissue, with severe clinical symptoms and cases where treatment is recommended after evaluation.
  3. Tracheal injury or tissue defect caused by trauma or burns: Cases requiring surgical repair.
  4. Tracheal tumors: Reconstruction of tracheal tissue following the removal of benign or malignant tumors.

Exclusion criteria

Exclusion Criteria:

  1. Patients who are unable to provide informed consent.
  2. Pulmonary tumors that can be treated with standard lobectomy.
  3. Locally invasive tumors that are unresectable.
  4. Presence of contralateral lymph node metastasis.
  5. Presence of distant metastasis, except for solitary, resectable brain metastasis.
  6. Tracheal lesions amenable to standard resection with direct anastomosis.
  7. Preoperative evaluation indicates inability to undergo standard lobectomy.
  8. Patients infected with human immunodeficiency virus (HIV) or with other immunodeficiency disorders.
  9. Any condition or circumstance deemed by the principal investigator to potentially interfere with the conduct of the trial (e.g., severely impaired cardiopulmonary function, significant liver or kidney dysfunction, poorly controlled diabetes, high-risk groups, or pregnancy).
  10. Individuals with concerns about the potential risks of the trial.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Cryopreserved aortic patch

    Using the cryopreserve aortic patch to repair the tracheobronchial defect.

    Procedure: Cryopreserved aortic patch

Interventions

  • ProcedureCryopreserved aortic patch

    After identifying the tracheal or bronchial defect with standard surgical techniques, the airway gap is reconstructed with a patch of human cryopreserved (-80 celsius degree) aortic allograft, which was not matched by the ABO and leukocyte antigen systems. The anastomosis is performed with standard technique for airway anastomosis. An silicon stent is inserted to prevent collapse for the aortic graft.

05

What researchers measure

Primary outcomes

  1. 90-day mortality

    The rate of death at 90 days.

    Time frame: 90 days

Secondary outcomes

  1. 90-day morbidity

    The occurrence of complication including 1) anastomotic leakage, 2) pneumonia, 3) difficult weaning, 4) airway obstruction by granulation tissue, 5) stenosis.

    Time frame: 90 days

06

Study locations

1 of 2 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Not yet recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    Recruiting
07

References and documents

Publications

  • Hung WT, Liao HC, Hsu HH, Chen JS. Stented cryopreserved aortic allograft for reconstruction of long-segment post-tuberculosis tracheal stenosis. J Formos Med Assoc. 2024 Jul;123(7):818-820. doi: 10.1016/j.jfma.2024.03.006. Epub 2024 Mar 16. PubMed 38494361 ↗
  • Martinod E, Radu DM, Onorati I, Portela AMS, Peretti M, Guiraudet P, Destable MD, Uzunhan Y, Freynet O, Chouahnia K, Duchemann B, Kabbani J, Maurer C, Brillet PY, Fath L, Brenet E, Debry C, Buffet C, Leenhardt L, Clero D, Julien N, Venissac N, Tronc F, Dutau H, Marquette CH, Juvin C, Lebreton G, Cohen Y, Zogheib E, Beloucif S, Planes C, Tresallet C, Bensidhoum M, Petite H, Rouard H, Miyara M, Vicaut E. Airway replacement using stented aortic matrices: Long-term follow-up and results of the TRITON-01 study in 35 adult patients. Am J Transplant. 2022 Dec;22(12):2961-2970. doi: 10.1111/ajt.17137. Epub 2022 Jul 14. PubMed 35778956 ↗
  • Martinod E, Chouahnia K, Radu DM, Joudiou P, Uzunhan Y, Bensidhoum M, Santos Portela AM, Guiraudet P, Peretti M, Destable MD, Solis A, Benachi S, Fialaire-Legendre A, Rouard H, Collon T, Piquet J, Leroy S, Venissac N, Santini J, Tresallet C, Dutau H, Sebbane G, Cohen Y, Beloucif S, d'Audiffret AC, Petite H, Valeyre D, Carpentier A, Vicaut E. Feasibility of Bioengineered Tracheal and Bronchial Reconstruction Using Stented Aortic Matrices. JAMA. 2018 Jun 5;319(21):2212-2222. doi: 10.1001/jama.2018.4653. PubMed 29800033 ↗
  • Karkhanis T, Byju AG, Morales DL, Zafar F, Haridas B. Composite Biosynthetic Graft for Repair of Long-Segment Tracheal Stenosis: A Pilot In Vivo and In Vitro Feasibility Study. ASAIO J. 2024 Jun 1;70(6):527-534. doi: 10.1097/MAT.0000000000002130. Epub 2024 Jan 3. PubMed 38170278 ↗
  • Allen MS. Surgery of the Trachea. Korean J Thorac Cardiovasc Surg. 2015 Aug;48(4):231-7. doi: 10.5090/kjtcs.2015.48.4.231. Epub 2015 Aug 5. PubMed 26290833 ↗
  • Etienne H, Fabre D, Gomez Caro A, Kolb F, Mussot S, Mercier O, Mitilian D, Stephan F, Fadel E, Dartevelle P. Tracheal replacement. Eur Respir J. 2018 Feb 14;51(2):1702211. doi: 10.1183/13993003.02211-2017. Print 2018 Feb. PubMed 29444919 ↗
  • Grillo HC. Development of tracheal surgery: a historical review. Part 2: Treatment of tracheal diseases. Ann Thorac Surg. 2003 Mar;75(3):1039-47. doi: 10.1016/s0003-4975(02)04109-7. No abstract available. PubMed 12645751 ↗
  • Grillo HC. Development of tracheal surgery: a historical review. Part 1: Techniques of tracheal surgery. Ann Thorac Surg. 2003 Feb;75(2):610-9. doi: 10.1016/s0003-4975(02)04108-5. No abstract available. PubMed 12607695 ↗
  • Madden BP. Evolutional trends in the management of tracheal and bronchial injuries. J Thorac Dis. 2017 Jan;9(1):E67-E70. doi: 10.21037/jtd.2017.01.43. PubMed 28203439 ↗
  • Prokakis C, Koletsis EN, Dedeilias P, Fligou F, Filos K, Dougenis D. Airway trauma: a review on epidemiology, mechanisms of injury, diagnosis and treatment. J Cardiothorac Surg. 2014 Jun 30;9:117. doi: 10.1186/1749-8090-9-117. PubMed 24980209 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06935110
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Apr 20, 2025
Start date
Sep 15, 2025
Primary completion
Jul 31, 2029 (estimated)
Completion
Oct 2029 (estimated)
Last update
Jun 12, 2026

Study contacts

Chao-Wen Lu, MD
Contact
i2363160@gmail.com
+886972652324
Jin-Shing Chen, MD, PhD
principal investigator · National Taiwan University Hospital, Taipei, 100

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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