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Trachea DiseasesNCT06935110

Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch

A study testing Cryopreserved aortic patch in people with Trachea Diseases and Airway Remodeling, run by National Taiwan University Hospital at 2 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cryopreserved aortic patch
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesTaiwan
Study dates
15 Sep 2025to Oct 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • Tracheal injury or tissue defect caused by trauma or burns: Cases requiring surgical repair.
  • Tracheal tumors: Reconstruction of tracheal tissue following the removal of benign or malignant tumors.

Who cannot join

  • Patients who are unable to provide informed consent.
  • Pulmonary tumors that can be treated with standard lobectomy.
  • Locally invasive tumors that are unresectable.
  • Presence of contralateral lymph node metastasis.
  • Presence of distant metastasis, except for solitary, resectable brain metastasis.
  • Tracheal lesions amenable to standard resection with direct anastomosis.
Show all 10Show fewer
  • Preoperative evaluation indicates inability to undergo standard lobectomy.
  • Patients infected with human immunodeficiency virus (HIV) or with other immunodeficiency disorders.
  • 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).
  • Individuals with concerns about the potential risks of the trial.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chao-Wen Lu, MD contact

+886972652324

i2363160@gmail.com

Taiwan2 sites, 2 recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Jin-Shing Chen, MD, PhD, 02-23123456 Ext. 65178, chenjs@ntu.edu.tw

    Not yet recruiting

  • National Taiwan University Hospital

    Taipei

    ChaoWen Dr., +886972652324, i2363160@gmail.com

    Recruiting

Other trials in Taiwan

About this study

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

Being tested
Cryopreserved aortic patch
Keywords
cryopreserved aortic patch, airway repair, tracheal reconstruction, bronchial reconstruction
Medical subject headings
Tracheal Diseases, Airway Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cryopreserved aortic patchProcedure or surgery

    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.

Study groups in NCT06935110
Study groupRoleWhat they receive
Cryopreserved aortic patchExperimentalUsing the cryopreserve aortic patch to repair the tracheobronchial defect.
Receives: Procedure: Cryopreserved aortic patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 90-day mortality

    The rate of death at 90 days.

    Measured: 90 days

Secondary outcomes (1)

  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.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2025
  2. Study start15 Sep 2025
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06935110
Sponsor's protocol ID
202407061DINE
Status last verified
Jun 2026
First submitted
11 Apr 2025
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Cryopreserved aortic patch in people with Trachea Diseases and Airway Remodeling, run by National Taiwan University Hospital at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chao-Wen Lu, MD (+886972652324, i2363160@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

90-day mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06935110, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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