Please select the eligibility criteria that correspond to the clinical trial below.
Title: Endobronchial Valve for Emphysema Palliation Trial (VENT)
Brief Summary: The purpose of this study is to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV) and procedure (with pulmonary rehabilitation) compared to optimal medical management (with pulmonary rehabilitation) in patients with heterogeneous emphysema.


Options:
A: Inclusion Criteria:

* Between 40 and 74 years of age
* Predominantly upper lobe emphysema and severe dyspnea
* Satisfies the criteria of the ATS/ERS Guidelines for Management of Stable COPD
* Physical ability to participate in the study by performing a 6-minute walk distance of \> 140m
* No cigarette smoking for 4 months and willing to abstain throughout the study
* Severe airflow obstruction defined by FEV1 45% of predicted
* Severe hyperinflation defined by: TLC \> 100% of predicted and RV \> 150% of predicted

Exclusion Criteria:

* Between 70 and 74 years of age and an FEV1 or DLCO \< 20% of predicted
* Severe gas exchange abnormalities
* Major medical disease that will limit evaluation, participation or follow-up
* Active asthma component to their disease
* Giant bulla (\> 1/3 volume of lung)
* Severe pulmonary hypertension
* Requirement for \> 6L02 to keep saturation \> 90% with exercise
* Evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period
B: Inclusion Criteria:

* clinical diagnosis of advanced upper lobe predominant emphysema
* age \>/= 40 years
* clinically significant dyspnea
* failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic)
* pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 \< 45% predicted and experiencing \< 30% or 300 mL improvement using bronchodilator; TLC \> 110% predicted; RV \> 150% predicted)
* 6 Minute Walk Distance \>/= 150 m

Exclusion Criteria:

* alpha-1 protease inhibitor deficiency
* homogeneous disease
* tobacco use within 4 months of initial visit
* body mass index \< 15 kg/m2 or \> 35 kg/m2
* clinically significant asthma, chronic bronchitis or bronchiectasis
* allergy or sensitivity to procedural components
* pregnant, lactating or unwilling to use birth control if required
* prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endobronchial valve placement, airway stent placement or pleurodesis
* comorbid condition that could adversely influence outcomes
* inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
C: Inclusion Criteria:

* Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution
* Forced expiratory volume in 1 second (FEV1) \< 45% predicted
* Total lung capacity (TLC) \> 100% predicted
* Residual volume (RV) \> 150% predicted
* Post rehabilitation 6 minute walk test \> 140m
* Non-smoking for 4 months

Exclusion Criteria:

* Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy
* History of recurrent respiratory infections
* Evidence of large bullae (\>30% of either lung) in a non-target lobe
* FEV1 \< 15% predicted
* Diffusing capacity for carbon monoxide (DLCO) \< 20% predicted
D: Inclusion Criteria:

* Greater than or equal to 35 years of age
* bilateral heterogenous emphysema
* Patient has stopped smoking for a minimum of 8 weeks
* Read, understood and signed the Informed consent form

Exclusion Criteria:

* Patient has a history of recurrent significant respirator infection
* Patient has an inability to walk \> 140 meters
* Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
* Patient is pregnant or lactating
* Patient has clinical significant bronchiectasis
* Patient has had previous LVR surgery, lung transplant or lobectomy
* Patient has been involved in other pulmonary drug studies within 30 days prior to this study

Answer: C