COPD emphysema
Conditions
Interventions
Implantation of the Apreo Endobronchial Implant into the affected lung(s).
Sponsors
Medical Devices company - Apreo Health Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 35 and 35% destruction (percent of voxels with =15% and 180% predicted 7. Post-bronchodilator RV/TLC >= 0.55 at screening 8. Marked dyspnea, scoring >= 2 on the modified Medical Research Council scale of 0-4 9. Cotinine testing at screening indicates nonsmoker and stopped smoking at least 8 weeks before entering the trial and agrees to refrain from smoking for duration of study participation 10. Fully vaccinated for Covid-19 and has current pneumococcus and influenza vaccination (or documented clinical intolerance) 11. Cognitively and physically able to provide written informed consent and complete participant questionnaires
Exclusion criteria
Exclusion criteria: 1. Arterial blood PaCO2 > 60 mmHg (8 kPa) or PaO2 = 30% of hemithorax) 10. History of excessive dynamic airway collapse of the trachea or main bronchi 11. History of adult asthma or chronic bronchitis 12. Presence of suspicious pulmonary nodule/infiltrate that requires additional follow-up, diagnostics or treatment 13. Unequivocal and symptomatic bronchiectasis 14. Unequivocal lung cancer or other current cancer diagnosis except non-metastasized basal cell skin cancer 15. Uncontrolled hypertension (blood pressure that is inadequately treated or resistant to treatment) with a systolic > 200 mmHg or diastolic > 110 mmHg at screening or prior to first Apreo Procedure 16. Uncorrectable coagulopathy or other condition likely to increase risk of peri- or post- Apreo Procedure bleeding 17. On anticoagulant or antiplatelet therapy and unable or unwilling to hold for Apreo Procedure 18. Coronary artery disease with angina 19. History of myocardial infarction within 6 months 20. History of a stroke less than 1 year before the first Apreo Procedure 21. Clinical history of heart failure with documented LVEF 9.0% 23. Estimated glomerular filtration rate (eGFR)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the rate of occurrence of serious adverse events (SAE) related to the device and/or study procedure through 6 months post-Apreo Procedure #1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility endpoints include: • Evaluation of ability to deploy the Apreo Implant in target airways • Evaluate operator device use challenges • Evaluation of operator understanding of instructions for use Preliminary efficacy endpoints include: • Implant obstruction assessed bronchoscopically in the proximal, medial and distal thirds at 3- and 6--month visits using a semi-quantitative scale (0-5) with 0 representing no narrowing within the lumen of the implant, 1: 1% - 10%, 2: >10% - 25%, 3: >25% - 50%, 4: >50% - 75%, 5: >75% - 100%. • Mucous within the Apreo Implant assessed bronchoscopically in the proximal, medial and distal thirds at 3- and 6--month visits using a semi-quantitative scale with 0: No mucous within the lumen of the implant, 1: Minimal, 2: Mild, 3: Moderate, 4: Severe, 5: Copious. • CT assessment of Apreo Implant diameter in mm at the middle of the implant, 5 mm proximal to the distal end and 5 mm distal to the proximal end at 6- and 12-month visits • Change in the following at 1-3 days, 30 days, and 3, 6, and 12 months post-Apreo Procedure #1 relative to baseline: o FEV1 o RV assessed by pulmonary function testing o RV/TLC o FVC o FEV1/FVC o Exercise capacity (6MWD) o SGRQ-C Score o CAT Score o mBORG Scores o mMRC Score • Change in DLCO at 6 months post-Apreo Procedure #1 relative to baseline • Change in RV assessed by quantitative CT analysis at 6 and 12 months post-Apreo Procedure #1 relative to baseline • ABG parameters: PaO2 and PaCO2 at 6 months post-Apreo Procedure #1 relative to baseline Secondary Safety Endpoints • Percentage of participants with acute procedural complications (within 24 hours of an Apreo Procedure • Rates of occurrence of serious adverse events (SAE) related to the device and/or Apreo Procedure through 24 months post-Apreo Procedure #1 • Rates of adverse device effects through 24 months post-Apreo Procedure #1 | — |
Countries
Netherlands
Outcome results
None listed