COPD Emphysema
Conditions
Interventions
Nitinol Lung Volume Ruduction Coils will be placed in both lungs during two
bronchoscopic procedures, aiming to induce a volume reduction and therefore
aiming to improve the clinical status of emphy
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject paticipated in the RENEW study and was randomized for the CONTROLgroup. This patient completed 12 month follow-up visit. >=35 years of age. CT scan indicates bilateral emphysema. Subject has post-bronchodilator FEV1 100% predicted. Subject has residual volume (RV) >=225% predicted. Subject has marked dyspnea scoring >=2 on mMRC scale of 0-4.
Exclusion criteria
Exclusion criteria: Subject has co-morbidities that may significantly reduce subject*s ability to improve exercise capacity (e.g. severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea. Subject has a change in FEV1 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator. Subject has DLCO 55 mm Hg, PaO2 50 mm Hg via right heart catheterization and/or echocardiogram. Subject has an inability to walk >140 meters. Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study. Subject has clinically significant bronchiectasis. Subject has giant bullae >1/3 lung volume. Subject has had previous LVR surgery, lungtransplantation, lobectomy , LVR devices or other devices to treat COPD in either lung. Subject has been involved in pulmonary drug or device studies within 30 days prior to this study. Subject is taking >20 mg prednisone (or equivalent dose of a similar steroid) daily. Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder. Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped for seven (7) days prior to procedure. Subject has a sensitivity or allergy to Nickel Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to provide the LVRC procedure and safety and effectiveness follow up to qualifying subjects who were enrolled as Control Subjects in and completed the 12 month visit of the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive statistics will be used to evaluate the data, including differences from Baseline to 12 months in 6MWT and SGRQ, and safety. | — |
Countries
Netherlands
Outcome results
None listed