A Prospective, Randomized, Controlled Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the IBV(RegisteredTM) Valve System for the Single-Lobe Treatment of Severe Emphysema (EMPROVE)
- Clements University Hospital
Muhanned Abu-Hijleh, M.D.
treatment with the iBV Valve System as compared to medical management in the control group. The control group will be evaluated in the same fashion as the treatment group. Subjects will be randomized in a 2:1 allocation ratio to either the treatment group or the control group. The study is expected to enroll up to 270 subjects at up to 20 investigational sites.
The study design includes planned interim analyses that will calculate probabilities of possible future outcomes for the primary endpoint related to the mean change (baseline to 6 months) in the forced expiratory volume in 1 second (FeV1). on the basis of these calculated probabilities, the study can be stopped early for success or futility, or the sample size can be increased up to a maximum of 270 patients.
1. 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% point disease severity 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[Single Quote]s obstructive disease is severe as defined by:
* FEV1 <= 45% of predicted.
9. Subject[Single Quote]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.