Fissure Closure with the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients with Severe Emphysema; A Multicenter, Prospective Trial
- Conditions
- COPDemphysema10038716
- Registration Number
- NL-OMON52333
- Lead Sponsor
- Pulmonx Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
1. Subject is willing and able to provide Informed Consent and to participate
in the study.
2. Subject is >= 40 and <= 75 years of age at the time Informed Consent signature.
3. Subject has at least one lobe with >= 50% emphysema destruction (at *910 HU)
as determined
by QCT.
4. Subject has a diagnosis of homogenous or heterogeneous emphysema, confirmed
by HRCT
scan. Heterogeneous emphysema defined as >= 15% difference (at -910 HU) in
emphysema
destruction score of adjacent lobes by HRCT.
5. Subject has a gap in the interlobar fissure that corresponds to one or more
segments as
determined by QCT.
6. Subject has clinically significant dyspnea with a mMRC Dyspnea score >= 2.
7. Subject has a Six-Minute Walk Distance >= 250 meters.
8. Subject has post-bronchodilator FEV1 >= 15% predicted and <= 50% predicted.
9. Subject has post-bronchodilator Total Lung Capacity >= 100% predicted.
10. Subject has post-bronchodilator Residual Volume >= 150% predicted if
heterogeneous
emphysema and >= 200% predicted if homogeneous emphysema.
11. Subject has stopped smoking for at least eight (8) weeks prior to Screening
visit as confirmed
by carboxyhemoglobin or cotinine levels.
12. Subject has received preventive vaccinations against potential respiratory
infections
consistent with local recommendations or policy.
Exclusion Criteria
1. Subject has severe bullous emphysema where bulla is >= 1/3 of the total lung
volume.
2. Subject has had prior lung volume reduction surgery, prior lobectomy or
pneumonectomy,
prior lung transplantation, prior airway stent placement, prior ipsilateral
pleurodesis, or prior
endobronchial lung volume reduction therapy of any type.
3. Subject has evidence of active respiratory infection.
4. Subject has an ongoing COPD exacerbation or bronchospasm.
5. Subject has a known allergy to the device components:
a. Polyether block amide - PEBAX®
b. Polyvinyl Alcohol
c. Glutaraldehyde
d. Nitinol (nickel-titanium) or its constituent metals (nickel or titanium)
e. Silicone
6. Subject requires ventilatory support (invasive or non-invasive).
7. Subject has post-bronchodilator Diffusion Capacity (DLCO) < 20% predicted.
8. Subject cannot tolerate corticosteroids or relevant antibiotics.
9. Subject has other relevant comorbidities as judged by the Investigator or is
deconditioned
and cannot tolerate the stress of post-treatment inflammatory response.
10. Subject has had three (3) or more COPD exacerbations requiring
hospitalization during the
year prior to Informed Consent signature.
11. Subject has severe gas exchange abnormalities as defined by any one of the
following (test
conducted at rest on room air as tolerated, or on up to 4 L/min supplemental O2)
a. PaCO2 >= 55 mm Hg (7.3 kPa)
b. PaO2 < 45 mm Hg (6.0 kPa)
c. SpO2 < 90%
12. Subject has uncontrolled pulmonary hypertension, defined as peak pulmonary
systolic
pressure > 45 mm Hg on echocardiogram or right heart catheterization.
13. Subject use of systemic steroids > 20 mg/day prednisolone or equivalent
within 4 weeks of
Informed Consent signature.
14. Subject use of immunosuppressive agents within four (4) weeks of Informed
Consent
signature.
15. Subject whose use heparins and oral anticoagulants (e.g., warfarin,
dicumarol) cannot be
discontinued according to local pre-procedural protocols. Note: antiplatelet
drugs including
aspirin and clopidogrel are permitted.
16. Subject*s CT scan indicates the presence of any the following radiologic
abnormalities:
a. Pulmonary nodule on CT scan greater than 0.8 cm in diameter (Does not apply
if
present for one (1) year or more without increase in size or if proven benign by
biopsy).
b. Radiologic picture consistent with active pulmonary infection, e.g.,
unexplained
parenchymal infiltrate.
c. Significant interstitial lung disease.
d. Significant pleural disease.
17. Subject*s baseline EKG indicates non-atrial arrhythmias or conduction
abnormalities.
18. Subject has high cardiac risk after undergoing cardiac risk assessment in
accordance with
published guidelines18 or ischemic heart disease, congestive heart failure,
renal failure, or
cerebrovascular disease.
19. Subject has clinically significant asthma (reversible airway obstruction),
chronic
bronchitis, or bronchiectasis.
20. Subject has allergy or sensitivity to medications required to safely
perform bronchoscopy
under conscious sedation or general anesthesia.
21. Subject participated in an investigational study of a drug, biologic, or
device not currently
approved for marketing within 30 days prior to Screening visit. Subjects being
followed as
part
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Stage 1 (Post-AeriSeal):<br /><br>The Primary AeriSeal Endpoint is the percentage of study subjects that are<br /><br>successfully converted from a positive collateral ventilation status<br /><br>(CV+) in the treated lobe to having little to no collateral ventilation (CV-)<br /><br>by Chartis in the treated lobe, six (6) weeks after delivery of AeriSeal.<br /><br><br /><br>Stage 2 (Post-Zephyr Valves):<br /><br>The Primary Zephyr Valve Endpoint is the percent of subjects achieving Treated<br /><br>Lobar Volume Reduction (TLVR) >= 350 mL at 45- days post successful lobar<br /><br>occlusion with Zephyr Valves.</p><br>
- Secondary Outcome Measures
Name Time Method