NCT06935110

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
41mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Sep 2025Oct 2029

First Submitted

Initial submission to the registry

April 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

December 3, 2025

Status Verified

April 1, 2025

Enrollment Period

3.9 years

First QC Date

April 11, 2025

Last Update Submit

November 25, 2025

Conditions

Trachea DiseasesAirway RemodelingReconstruction Surgery

Keywords

cryopreserved aortic patchairway repairtracheal reconstructionbronchial reconstruction

Outcome Measures

Primary Outcomes (1)

  • 90-day mortality

    The rate of death at 90 days.

    90 days

Secondary Outcomes (1)

  • 90-day morbidity

    90 days

Study Arms (1)

Cryopreserved aortic patch

EXPERIMENTAL

Using the cryopreserve aortic patch to repair the tracheobronchial defect.

Procedure: Cryopreserved aortic patch

Interventions

Cryopreserved aortic patchPROCEDURE

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.

Cryopreserved aortic patch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hospital

Taipei, 100, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (10)

  • 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.

    PMID: 38494361BACKGROUND

  • 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.

    PMID: 35778956BACKGROUND

  • 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.

    PMID: 29800033BACKGROUND

  • 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.

    PMID: 38170278BACKGROUND

  • 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.

    PMID: 26290833BACKGROUND

  • 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.

    PMID: 29444919BACKGROUND

  • 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.

    PMID: 12645751BACKGROUND

  • 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.

    PMID: 12607695BACKGROUND

  • 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.

    PMID: 28203439BACKGROUND

  • 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.

    PMID: 24980209BACKGROUND

MeSH Terms

Conditions

Tracheal DiseasesAirway Remodeling

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jin-Shing Chen, MD, PhD

    National Taiwan University Hospital, Taipei, 100

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Wen Lu, MD

CONTACT

+886972652324i2363160@gmail.com

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

April 11, 2025

First Posted

April 20, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

December 3, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)