A RandomizEd ControlLed Study of PnEumRx Endobronchial Coil System Versus Standard-of-Care Medical MAnagement in the Treatment of Subjects with Severe Emphysema (ELEVATE) A Postmarket Surveillance Study (PMS).

Completed

• Conditions: COPD; emphysema; 10038716

• Registration Number: NL-OMON46536
• Lead Sponsor: PneumRx, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1. Read, understood and signed the Informed Consent form
2. Meets indications for use per the IFU
3. Bilateral heterogeneous and/or homogeneous emphysema
4. 15% predicted * Post bronchodilator Forced Expiratory Volume in 1 second (FEV1) * 45% predicted
5. Post bronchodilator Residual Volume (RV) * 200% predicted
6. Post bronchodilator Total Lung Capacity (TLC) >100% predicted
7. Post bronchodilator RV/TLC > 55%
8. Dyspnea * 2 on modified Medical Research Council (mMRC) dyspnea scale despite optimal medical management
9. Receiving optimal drug therapy and medical management according to clinical practice.
10. Performing regular physical activity, at least 2 times per week 3
11. Stopped smoking as confirmed by carboxyhemoglobin (CoHB)
12. 100m * 6 minute walk distance (6MWD) * 450m
13. Deemed eligible per Eligibility Review Committee (ERC)

Exclusion Criteria

1. Meets any of the contraindications listed in the IFU
2. Primary diagnosis of asthma
3. Two (2) or more COPD exacerbations in the prior year, or 1 or more COPD exacerbations in the prior 3 months with indication for hospitalization assessment, according to GOLD 2017 recommendations4.
4. Predominant small airways disease defined as significant bronchiectasis with sputum production (> 2 tablespoons daily) or significant bronchial wall thickening per High Resolution Computed Tomography (HRCT)
5. Percent Low Attenuation Area (%LAA) < 20% in the most damaged lobe of either lung.
6. Computed Tomography (CT) Imaging consistent with active pulmonary infection, significant interstitial disease or pleural disease (predominant bulla > 8cm or 1/3 hemithorax), or severe bullous or predominant paraseptal emphysema pattern
7. Lung pathology of nodule not proven stable or benign
8. Radiographic confirmation of atelectasis or other scarring/fibrosis in areas of intended Coil implant 9. Use of more than 10 mg/day prednisolone or equivalent dosage of a different corticosteroid
10. Severe pulmonary hypertension (Right Ventricular Systolic Pressure (RVSP) > 50 mm Hg or other signs of Pulmonary Hypertension (PHT) with right ventricular dysfunction)
11. Severe hypercapnia (PaCO2 > 55 mmHg on room air) and/or severe hypoxemia (PaO2 < 45mm Hg on room air, High altitude criterion: PaO2 < 30 mm Hg)
12. Previous Lung Volume Reduction (LVR) surgery, lung transplantation, lobectomy, LVR devices or other device to treat COPD in either lung.
13. Diagnosed with alpha-1 antitrypsin deficiency
14. DLCO < 20 %
15. Significant, recent or unstable cardiac disease defined as severe heart failure (Left Ventricular Ejection Fraction (LVEF) < 45% despite optimal medical management), unstable cardiac arrhythmia or coronary artery disease (angina on activity), or ischemic event in the past 6 months.
16. Body Mass Index (BMI) > 30.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety: number and kind of (serious) adverse events<br /><br><br /><br>Co-Primary Effectiveness Endpoints:<br /><br>* Percent change in FEV1 from baseline to 6 months and<br /><br>* Change in SGRQ from baseline to 6 months</p><br>