EMPROVE

Principal Investigator: Chakravarthy Reddy
Keywords: Emphysema , COPD Department: Pulmonary
IRB Number: 00064941 Co Investigator:  
Specialty: Pulmonary, Pulmonary
Sub Specialties: Pulmonary, Airway Disorders
Recruitment Status: Recruiting

Contact Information

Dominique Ferranti
dominique.ferranti@hsc.utah.edu
801-581-5811

Brief Summary

The objective of this randomized controlled study is to demonstrate the ability of the Spiration Valve System to be safely deployed in selected airways of human subjects and to improve lung funciton

This study is designed to confirm the effectiveness and safety of these improved selection criteria combined with the single-lobe full occlusion treatment algorithm in a multi-center, randomized, controlled study. In addition, this study will further define objective methods for using HRCT for patient selection.

This study will address a significant clinical need for new therapies in patients with severe emphysema. The Spiration Valve System (SVS) has been studied sufficiently to proceed with this multi-center, randomized, controlled study.

Inclusion Criteria

 

Subject is 40 years of age or older.

2. Subject has severe emphysema and high heterogeneity defined as: a target lobe with ≥ 40% emphysema involvement and ≥ 10% difference with the ipsilateral lobe.

3. The target lobe and ipsilateral lobe will be separated with an intact fissure. An intact fissure will be estimated visually to be ≥ 90% complete with no segmental vessels crossing from one lobe to the adjacent lobe after viewing the HRCT in 3 dimensions.

4. Subject meets the criteria of the ATS/ERS Guidelines for Management of Stable COPD.

5. Subject must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m.

6. Subject has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study.

7. Subject must have severe dyspnea which is defined as a mMRC ≥ 2.

8. Subject’s obstructive disease is severe as defined by:

• FEV1 ≤ 45% of predicted.

9. Subject’s hyperinflation is defined by:

• TLC ≥ 100% of predicted

RV ≥ 150% of predicted

10. Subject is willing to participate in a controlled study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period.

11. Investigator has confirmed that medical management is within standard of care and has been stable and without a COPD exacerbation for 6 weeks or more.

12. Subject provides informed consent and is willing and able to return for all study examinations.

13. Subjects with α1 antitrypsin deficiency must have confirmatory blood test.

 

Exclusion Criteria

1. Subject has a severe gas exchange abnormality in either PCO2 or PO2 as defined by:

  • PCO2 > 55 mm Hg, or
  • PO2 < 45 mm Hg on room air,

2. Subject has co-existing major medical disease, alcoholism, or drug abuse potential that will limit evaluation, participation, or follow-up during the 6-month study period. This includes neurological or musculoskeletal conditions that may interfere with testing.

3. Patient has a BMI < 15 kg/m2.

4. Subject had a hospitalization for COPD exacerbation or respiratory infections in the past 3 months prior to baseline testing.

5. Subject has bronchitis with sputum production > 4 Tablespoons or 60 ml per day.

6. Subject has an active asthma component to their disease or requires more than 15 mg of prednisone daily.

7. Subject has giant bulla (> 1/3 volume in either lung).

8. Patient has severe pulmonary hypertension based upon clinical evaluation. (Severe pulmonary hypertension is an exclusion for this study.  Patients with imaging or EKG evidence of pathological enlargement of the pulmonary arteries or right heart may have severe pulmonary hypertension.  If clinically indicated, a patient may be included if a right heart catheterization PAP value of < 45mmHg (done for clinical reasons) is acceptable for enrollment)

9. Subject has had prior lung volume reduction surgery or major lung procedures (lobectomy or greater),

10. Subject has a lung nodule anticipated to require evaluation or intervention during the 6 month study period,

11. Subject has demonstrated unwillingness or inability to complete screening or baseline data collection procedures,

12. Subject has a diffuse emphysema pattern

13. Subject is classified as ASA Class greater than P4 including presence of co-morbidity that could significantly increase the risk of a bronchoscopy procedure.

14. Subject participated in a study of an investigational drug or device within the 30 days prior to participation in this study, or is currently participating in another clinical study.