Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)

The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.

• Device: Lung Volume Reduction Coil (LVRC) (PneumRx)
  Lung Volume Reduction Coil (LVRC)
  Other Name: LVRD
• Device: Control
  Standard of Care
  Other Name: LVRC Control treatment is Standard of Care

• Experimental: Lung Volume Reduction Coil (LVRC)
  Lung Volume Reduction Coil (LVRC)
  Intervention: Device: Lung Volume Reduction Coil (LVRC) (PneumRx)
• Placebo Comparator: Control
  Standard of Care
  Intervention: Device: Control

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