Biodegradable Stents in Lung Transplantation

Lung Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929942
• Other study ID #: 5237
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2009
• Last updated: July 20, 2011
• Start date: June 2009
• Est. completion date: April 2011

Study information

• Verified date: June 2009
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Device:
• SX-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.

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	ELLA-CS, Czech Republic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Show that DV stent can be safely placed in LTx recipients and are effective in relief of symptoms associated with OAC.		6 months	Yes
Secondary	To demonstrate mucosal healing in the first 6 months after stent insertion.		6 months	Yes