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Completed

NCT Number: NCT00929942

Biodegradable Stents in Lung Transplantation

A prospective observational trial involving 10 patients is planned. Intervention "SX-ELLA Stent Degradable DV Bronchial (DV Stent)" will be implanted in the target lesion in general anesthesia under fluoroscopy or by direct vision. Before dilatation, extension of the airway complications will be measured by bronchoscopy and documented.

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Key information

Conditions

Lung Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hannover Medical School

Hanover, 30625, Germany

About this study

Obstructive airway complications (OAC) (bronchial stenosis) are a significant problem in lung transplantation (LTx), and a special subset of chronic graft dysfunction. The overall rate is approximately 20% per recipient. Even though disobliteration (laser, argon-coagulation, cryotherapy) or balloon dilatation (bronchoplasty) are performed there is a high rate of recurrence. Self expandable metallic stents (SEMS) is one suggested treatment option after failed initial therapy but have a high rate of re-stenosis (50-60%). Morbidity, the risk for e.g. infection and atelectasis and lower long-term survival are often consequences in pts. treated with SEMS. No surgical options aside from re-do-transplantation are available. OAC are developing mostly in the time 3 - 6 months post Tx. The idea is a permanent but temporary therapy with replacement character of the stenosis which is given in degradable bronchial stents.

Hypothesis: New biodegradable bronchial stents are a successful treatment of benign bronchial stenosis after lung transplantation. After stent placement is further disobliteration is less frequently used during the next 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recurrent airway complication (obstructive or necrotic) after single-order double-lung transplantation (at least twice balloon-dilatation or disobliteration therapy).
  • Patient at least 3 months after lung transplantation and followed in MHH outpatient clinic.
  • Target lesion in the left or right main stem bronchus, intermediate bronchus, right or left lower lobe, left upper lobe. Multiple lesions are eligible for inclusion and treatment but DV-stent implantation in different target lesions should be at least 6 weeks apart.

Exclusion criteria

  • Pregnant or breast feeding women.
  • Patients who are using no double-barrier method of birth control.
  • Previous use of a metallic stent (SEMS).
  • Target lesion in the middle lobe bronchus, right upper lobe, carina or trachea.
  • Previous use of brachytherapy or topical mitomycin.
  • Pats. after heart-lung transplantation.

Treatment and study plan

SX-ELLA Stent Degradable DV Bronchial (DV Stent)

Device

Intervention "SX-ELLA Stent Degradable DV Bronchial (DV Stent)" will be implanted in the target lesion in general anesthesia under fluoroscopy or by direct vision. Before dilatation, extension of the airway complications will be measured by bronchoscopy and documented.

Primary outcomes

  1. Show that DV stent can be safely placed in LTx recipients and are effective in relief of symptoms associated with OAC.

    Time frame: 6 months

Secondary outcomes

  1. To demonstrate mucosal healing in the first 6 months after stent insertion.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Collaborators

  • ELLA-CS, Czech Republic

Registry information

Official study title

Treatment of Benign Bronchial Airway Stenoses in Patients After Lung Transplantation With a Biodegradable Stent - a Proof of Concept Study

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2009
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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