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

Boston Scientific

Status and phase

Completed

Phase 1

Conditions

Emphysema

Treatments

Device: Control

Device: Lung Volume Reduction Coil (LVRC) (PneumRx)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01334307

CLN0008

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

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