Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation Study of Unilateral Bronchoscopic Thermal Vapor Ablation (BTVA) in Patients With Heterogeneous Emphysema and Upper Lobe Predominance
Brief Summary: To establish and confirm the safety and clinical utility of BTVA applied unilaterally for lung volume reduction in patients with upper lobe predominate heterogeneous severe emphysema.


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:

1. Willing and able to provide informed consent
2. Age ≥ 40 years
3. On optimal medical therapy\* for more than 1 month
4. Advanced upper lobe predominant emphysema confirmed by CT scan
5. Two (2) subsegments appropriate for treatment in 2 different upper lobe segments in each lung based upon CT scan (total 4 available subsegments)
6. MRCD score of ≥ 2 post pulmonary rehab (using modified MRCD scale of 0-4)
7. 6MWT distance ≥ 150 m post pulmonary rehab
8. Spirometry 15 minutes after administration of a bronchodilator showing BOTH:

   1. FEV1 \< 50% predicted
   2. FEV1/FVC ratio \< 70%
9. Plethysmographic lung volumes showing BOTH:

   1. TLC \> 100% predicted
   2. RV \> 150% predicted
10. DLco ≥ 20% and ≤ 60% predicted
11. Blood gases and oxygen saturation showing BOTH:

    1. SpO2 ≥ 90% on ≤ 4 L/min supplemental O2
    2. PaCO2 \< 65 torr
12. Smoking history of ≥ 20 pack-years with abstinence for 16 weeks

Exclusion Criteria:

1. Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
2. Requirement for ventilator support (other than CPAP or BPAP for sleep apnea)
3. Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks
4. Use of systemic steroids \> 20 mg/day or equivalent immunosuppressive agents, heparins, oral anticoagulants or investigational medications

   Exclusion Criteria (continued):
5. a-1 antitrypsin serum level of \< 80 mg/dL (immunodiffusion) or \< 11 µmol/L (nephelometry)
6. CT scan: Presence of any of the following radiologic abnormalities:

   1. Pulmonary nodule on CT scan greater than 1.0 cm in diameter
   2. Radiologic picture consistent with active pulmonary infection
   3. Significant interstitial lung disease
   4. Significant pleural disease
   5. Giant bullous disease
7. Clinically significant asthma
8. Clinically significant bronchiectasis
9. Pulmonary hypertension
10. Allergy or sensitivity to medications required to safely perform AeriSeal System treatment under general anesthesia or conscious (moderate procedural) sedation
11. Participation in an investigational study of a drug, biologic, or device not currently approved for marketing
12. Body mass index \< 15 kg/m2 or \> 35 kg/m2
13. Female patient pregnant or breast-feeding or planning to be pregnant in the next year
14. Any abnormal screening laboratory test result
15. Significant comorbidity including any of the following:

    1. HIV/AIDs
    2. Active malignancy
    3. Stroke or TIA within 12 months
    4. Myocardial infarction within 12 months
    5. Congestive heart failure within 12 months
16. Any condition that would interfere with the intent of the study or would make participation not in the best interest of the patient such as alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits
C: Inclusion Criteria:

1. Age: \> 40 and ≤ 75 years old
2. Diagnosis of heterogeneous emphysema with upper lobe predominance
3. FEV1 \< 45% predicted
4. TLC \> 100% predicted
5. RV \> 150% predicted
6. 6-minute walk test \> 140 meters
7. mMRC ≥ 2 (mMRC)
8. Non-smoking for 3 months
9. Optimized medical management and completed pulmonary rehabilitation

Exclusion Criteria:

1. Known α-1-antitrypsin deficiency
2. BMI \< 15 kg/m2 or \> 35 kg / m2
3. History of pneumothorax within previous 18 months
4. History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy
5. Respiratory infections or recurring COPD exacerbations \> 3 hospitalizations in past 12 months or active infection
6. History of the (EF) ≤ 40%; Stroke; Unstable Myocardial Ischemia; FEV1 \< 15% predicted; DLCO \< 20% predicted; pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding
D: Inclusion Criteria:

* Patient greater than or equal to 35 years of age
* High resolution CT scan indicates unilateral or bilateral emphysema
* High resolution CT scan indicates homogeneous or heterogeneous emphysema
* Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
* Total Lung Capacity greater than 100% predicted
* Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4
* Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
* Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion Criteria:

* Patient has a change in FEV1 greater than 20% post-bronchodilator
* Patients DLCO less than 20% predicted
* Patient has a history of recurrent clinically significant respiratory infection
* Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
* Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
* Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
* Patient is pregnant or lactating
* Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia
* Patient has clinically significant bronchiectasis
* Patient has giant bullae greater than 1/3 lung volume
* Patient has had previous LVR surgery, lung transplant or lobectomy
* Patient has been involved in other pulmonary drug studies with 30 days prior to this study
* Patient is taking greater than 20 mg prednisone (or similar steroid) daily
* Patient is on Plavix or has not been weaned off prior to procedure
* Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Answer: C