Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR) in Subjects With Heterogeneous Emphysema
Brief Summary: Use of the Chartis® Assessment System prior to EBV Treatment


Options:
A: Inclusion Criteria:

* Subject is greater than or equal to 35 yrs of age
* CT Scan indicates bilateral emphysema, as determined by the Core Radiology Lab using the criteria presented in the "CT Scoring Plan for Core Radiology Lab"
* Subject has post-bronchodilator FEV1 less than or equal to 45% predicted
* Subject has Total Lung Capacity \>100% predicted
* Subject has residual volume (RV) greater than or equal to 175% predicted
* Subject has marked dyspnea greater than or equal to 2 on mMRC scale of 0-4
* Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by a Cotinine test or other appropriate diagnostic test.
* Subject has completed a pulmonary rehabilitation program within 6 mos prior to treatment and/or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 mos prior to baseline testing.
* Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy.
* Subject (and legal guardian, if applicable) has read, understood, and signed the Informed Consent form.

Exclusion Criteria:

* Subject has severe homogeneous emphysema determined by Core Radiology Lab.
* 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 of greater than 20% (or, for subjects with pre-bronchodilator FEV1 below 1L, a change of greater than 200mL) post-bronchodilator unless investigator can confirm by other means that subject does not have asthma.
* Subject has DLCO of less than 20% of predicted.
* Subject has severe gas exchange abnormalities, PaCO2 of greater than 55mm Hg; PaO2 of less than 45 mm Hg on room air (high altitude criterion: PaO2 of less than 30mm Hg).
* Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
* Subject as severe pulmonary hypertension defined by right ventricular systolic pressure of greater than 50mm Hg via right heart catheterization and/or echocardiogram
* Subject has an inability to walk \>140m (150 yd) in 6 minutes
* 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 is pregnant or lactating, or plans to become pregnant within the study timeframe.
* Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
* Subject has clinically significant bronchiectasis.
* Subject has giant bullae \>1/3 lung volume
* Subject has had previous LVR surgery, lung transplantation, lobectomy or LVR devices or other device 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 \>20mg 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 7 days prior to the procedure.
* Subject has any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
* Subject has a sensitivity or allergy to nitinol (nickel-titanium) or its constituent metals.
* Subject has a known sensitivity to drugs required to perform bronchoscopy.
* Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).
B: Inclusion Criteria:

* Patients must have a diagnosis of advanced upper lobe predominant (ULP) emphysema or advanced disease in the superior lower lobes as defined by FEV1/FVC \<70 % predicted, FEV1 of \< 50% predicted, TLC \> 100% of predicted, and RV \> 135% predicted.
* Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
* Patients must be \> 40 years of age, have symptoms despite medical therapy, and have none of the pre-specified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
C: Inclusion Criteria:

* Bilateral emphysema on Chest CT Scanner
* Post bronchodilator FEV1 \< 50 %
* Total Lung Capacity \> 100 %
* Residual Volume \> 220 %
* Dyspnea score between 2 and 4 based on the mMRC scale
* Stopped cigarette smoking for more than 8 weeks
* Pulmonary rehabilitation within the previous twelve months
* Consent form signed
* Covered by Medical Insurance

Exclusion Criteria:

* Post bronchodilator FEV1 \< 15%
* Post-bronchodilator change in FEV1 \> 20%
* Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months
* COPD exacerbation requiring hospital stay within 3 months
* Pulmonary Hypertension (Pulmonary systolic pressure \>50 mmHg on cardiac echo)
* Patient unable to perform a 6-min walking test in room air
* Giant bulla of more than 1/3 of the lung field on Chest CT
* Strictly homogeneous emphysema on Chest CT
* Clinically significant bronchiectasis
* Past history of lobectomy, lung volume reduction surgery, lung transplantation
* Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer...)
* Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
* Contra-indication to general anesthesia
* Oral anticoagulant treatment (antivitamin K)
* Allergy to nitinol
* Inclusion in an other study assessing respiratory treatments
* Patient protected by the law
D: Inclusion Criteria:

* Heterogeneous emphysema
* Able to obtain a Chartis value during Assessment

Exclusion Criteria:

* Any co-existing major medical problems that would not make it possible for the subject to tolerate a bronchoscopic procedure.

Answer: D