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Biodegradable Stents in Lung Transplantation

This study has been completed.
Sponsor:
Collaborator:
ELLA-CS, Czech Republic
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00929942
First received: June 29, 2009
Last updated: July 20, 2011
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Lung Transplantation
 Device: SX-ELLA Stent Degradable DV Bronchial (DV Stent)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Benign Bronchial Airway Stenoses in Patients After Lung Transplantation With a Biodegradable Stent - a Proof of Concept Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To demonstrate mucosal healing in the first 6 months after stent insertion. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: June 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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.
Other Name: SX-ELLA Stent Degradable DV Bronchial (DV Stent)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929942

Locations
Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
ELLA-CS, Czech Republic
Investigators
Principal Investigator: Jens T Gottlieb, M.D. Hannover Medical School
  More Information

No publications provided

Responsible Party: Karel Volenec, ELLA-CS, s.r.o.
ClinicalTrials.gov Identifier: NCT00929942     History of Changes
Other Study ID Numbers: 5237
Study First Received: June 29, 2009
Last Updated: July 20, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
lung transplantation
bronchial stenosis
biodegradable stent

ClinicalTrials.gov processed this record on May 22, 2013