Biodegradable Stents in the Management of Stenoses of the Large Airways

NCT02620319 | Suspended DMC

• 2 other identifiers: NT 14146-3/2013NT14146
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this project is to determine whether biodegradable polydioxanone stents are efficient in the treatment of adult patients with tracheobronchial stenoses.

Conditions

Tracheal Stenosis

Keywords

bronchoscopy; polydioxanone; absorbable implants; stents

Outcome Measures

Primary Outcomes (1)

• airway patency during the presence of the stent in the airways

  Scheduled bronchoscopies, trachea is, for the purposes of the study, classified according to Freitag's recommended adapted classification system (Freitag L. et al. A proposed classification system of central airway stenosis, Eur Respir J 2007; 30:7-12).

  residence time of the stent in the airways, i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support

Secondary Outcomes (4)

• number of complications: infection, bleeding, migration, obstructive granulation tissue formation, sudden restenosis (of any origin, unexpected in relation to the degree of the stent degradation)

  residence time of the stent in the airways (i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support) and 6 months thereafter

• evaluation of forced expiratory volume in 1 second (FEV1)

  residence time of the stent in the airways (i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support) and 6 months thereafter

• evaluation of forced vital capacity (FVC)

  residence time of the stent in the airways (i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support) and 6 months thereafter

• airway patency after complete degradation of the stent or loss of majority support functions

  six months, beginning after identifying the complete degradation of the stent or 180 days after implantation

Study Arms (1)

biodegradable stent

EXPERIMENTAL

endoscopic implantation of biodegradable airway stent, the SX-ELLA Stent DV Tracheal (DV Stent)

Device: SX-ELLA Stent DV Tracheal (DV Stent)

Interventions

SX-ELLA Stent DV Tracheal (DV Stent) DEVICE

The trachea is intubated with a rigid bronchoscope while participants are placed under total intravenous anesthesia and jet ventilation. The delivery apparatus containing the stent is introduced through a rigid tube to the desired depth under visual control. Then the stent is deployed and its position is determined and, if necessary, stent is repositioned using rigid forceps. In-stent balloon dilation is carried out. If needed, thoracic surgeon can secure the stent in place via external (percutaneous) fixation: one suture is passed through the stent, the tracheal wall, soft tissues, and skin; the suture is then knotted on the skin of the neck. The suture is removed two to three weeks after implantation.

Also known as: DV Stent

biodegradable stent

Eligibility Criteria

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

You may qualify if:

• significant large airway stenoses
• benign tracheobronchial stenosis of any origin in participants who can not go for surgery, or who refuse surgical treatment
• benign tracheobronchial stenoses of any origin when the surgery is planed after some delay, benign tracheobronchial stenoses when the effect of anti- inflammatory or anti-infective treatment is expected
• malignant tracheobronchial stenoses due to extrinsic compression when exhausted curative modalities
• malignant stenoses from extrinsic compression in participants undergoing the actinotherapy or receiving systemic anticancer therapy

You may not qualify if:

• stenoses of any origin which can be treated primarily surgically
• stenoses caused by intraluminal growth of tumor, tracheoesophageal or bronchoesophageal fistulas
• pregnancy

Sponsors & Collaborators

• Ludek Stehlik: lead
• Ministry of Health, Czech Republic: collaborator
• University Hospital Olomouc: collaborator
• University Hospital, Motol: collaborator

Study Sites (3)

Department of Respiratory Diseases and Tuberculosis, University Hospital Olomouc

Olomouc, 779 00, Czechia

Location

Department of Respiratory Medicine, Thomayer Hospital

Prague, 140 59, Czechia

Location

Department of Pneumology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital

Prague, 150 06, Czechia

Location

Related Publications (11)

• Novotny L, Crha M, Rauser P, Hep A, Misik J, Necas A, Vondrys D. Novel biodegradable polydioxanone stents in a rabbit airway model. J Thorac Cardiovasc Surg. 2012 Feb;143(2):437-44. doi: 10.1016/j.jtcvs.2011.08.002. Epub 2011 Aug 31.

  PMID: 21885070 BACKGROUND

• Lischke R, Pozniak J, Vondrys D, Elliott MJ. Novel biodegradable stents in the treatment of bronchial stenosis after lung transplantation. Eur J Cardiothorac Surg. 2011 Sep;40(3):619-24. doi: 10.1016/j.ejcts.2010.12.047. Epub 2011 Feb 21.

  PMID: 21334911 BACKGROUND

• Vondrys D, Elliott MJ, McLaren CA, Noctor C, Roebuck DJ. First experience with biodegradable airway stents in children. Ann Thorac Surg. 2011 Nov;92(5):1870-4. doi: 10.1016/j.athoracsur.2011.07.042. Epub 2011 Oct 31.

  PMID: 22051281 BACKGROUND

• Chin CS, Litle V, Yun J, Weiser T, Swanson SJ. Airway stents. Ann Thorac Surg. 2008 Feb;85(2):S792-6. doi: 10.1016/j.athoracsur.2007.11.051.

  PMID: 18222219 BACKGROUND

• Korpela A, Aarnio P, Sariola H, Tormala P, Harjula A. Bioabsorbable self-reinforced poly-L-lactide, metallic, and silicone stents in the management of experimental tracheal stenosis. Chest. 1999 Feb;115(2):490-5. doi: 10.1378/chest.115.2.490.

  PMID: 10027451 BACKGROUND

• Korpela A, Aarnio P, Sariola H, Tormala P, Harjula A. Comparison of tissue reactions in the tracheal mucosa surrounding a bioabsorbable and silicone airway stents. Ann Thorac Surg. 1998 Nov;66(5):1772-6. doi: 10.1016/s0003-4975(98)00763-2.

  PMID: 9875787 BACKGROUND

• Saito Y, Minami K, Kobayashi M, Nakao Y, Omiya H, Imamura H, Sakaida N, Okamura A. New tubular bioabsorbable knitted airway stent: biocompatibility and mechanical strength. J Thorac Cardiovasc Surg. 2002 Jan;123(1):161-7. doi: 10.1067/mtc.2002.118503.

  PMID: 11782770 BACKGROUND

• Freitag L, Ernst A, Unger M, Kovitz K, Marquette CH. A proposed classification system of central airway stenosis. Eur Respir J. 2007 Jul;30(1):7-12. doi: 10.1183/09031936.00132804. Epub 2007 Mar 28.

  PMID: 17392320 BACKGROUND

• Hytych V, Horazdovsky P, Stehlik L, Pracharova S, Pohnan R, Lefnerova S, Vasakova M. Our own method of fixation of biodegradable tracheal stent. Bratisl Lek Listy. 2015;116(5):340-2. doi: 10.4149/bll_2015_064.

  PMID: 25924646 RESULT

• Stehlik L, Hytych V, Letackova J, Kubena P, Vasakova M. Biodegradable polydioxanone stents in the treatment of adult patients with tracheal narrowing. BMC Pulm Med. 2015 Dec 21;15:164. doi: 10.1186/s12890-015-0160-6.

  PMID: 26690793 RESULT

• Stehlik L, Guha D, Anandakumar S, Taskova A, Vasakova MK. Biodegradable tracheal stents: our ten-year experience with adult patients. BMC Pulm Med. 2024 May 15;24(1):238. doi: 10.1186/s12890-024-03057-y.

  PMID: 38750487 RESULT

MeSH Terms

Conditions

Tracheal Stenosis

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases

Study Officials

• Ludek Stehlik, MUDr.

  Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4

  PRINCIPAL INVESTIGATOR

• Miloslav Marel, Prof. MUDr.

  Department of Pneumology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital

  STUDY DIRECTOR

• Vitezslav Kolek, Prof. MUDr.

  Department of Respiratory Diseases and Tuberculosis, University Hospital Olomouc

  STUDY DIRECTOR

• Martina Vasakova, Prof. MUDr.

  Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 3, 2015
• Study Start: May 1, 2013
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

CZ (3)