Status:
COMPLETED
Biodegradable Stents in Lung Transplantation
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
ELLA-CS, Czech Republic
Conditions:
Lung Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 f...
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 approximatel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00929942
Start Date
June 1 2009
End Date
April 1 2011
Last Update
July 22 2011
Active Locations (1)
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1
Hannover Medical School
Hanover, Germany, 30625