Biodegradable Stents in Lung Transplantation

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00929942

Enrollment

Registered

2009-06-30

Start date

2009-06-30

Completion date

2011-04-30

Last updated

2011-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplantation

Keywords

lung transplantation, bronchial stenosis, biodegradable stent

Brief summary

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.

Detailed description

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.

Interventions

DEVICESX-ELLA Stent Degradable DV Bronchial (DV Stent)

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Show that DV stent can be safely placed in LTx recipients and are effective in relief of symptoms associated with OAC.	6 months

Secondary

Measure	Time frame
To demonstrate mucosal healing in the first 6 months after stent insertion.	6 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026