A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe COPD/Emphysema (IAB-3)

Pulmair Medical

Status and phase

Begins enrollment this month

Phase 2

Conditions

Emphysema

COPD

Treatments

Device: Implantable pulmonary stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT07086339

IAB3-CIP-v01

Details and patient eligibility

About

A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema

Enrollment

20 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed Informed Consent
Diagnosis of COPD/emphysema
At least 22-years of age
18 ≤ BMI ≤ 32
6-minute walk Distance of between 100 - and 400 meters
Stable disease with less than 10-mg prednisone (or equivalent) daily
Non-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.).
FEV1 between 15% and 45% of predicted value at baseline exam
FEV1/FVC <70%
Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation less than -950 HU, as determined by CT core lab.
Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score less than -950 HU, as determined by CT core lab.
RV > 175% of predicted value.
mMRC score ≥ 2

Exclusion criteria

Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment
α-1 Antitrypsin deficiency
Women of child-bearing potential
More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening
Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention
Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening
Clinically significant mucus production or chronic bronchitis
Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening
Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR)
Clinically significant bronchiectasis
Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days
Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure >45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram
Suspected malignant pulmonary nodule or other lung cancer
HRCT collected per CT scanning protocol within the last 6 months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:
- Large bullae encompassing greater than 30% of either lung
- Insufficient landmarks to evaluate the CT study using the software as it is intended
- All lobes are less than 25% parenchyma diseased (< -950 HU).
Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant
TLC < 100% predicted at screening
DLCO < 15% or > 50% of predicted value at screening
PaCO2 > 50 mm Hg at screening
PaO2 < 45 mm Hg in room air at screening
Plasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) >2.5% at screening.
Current diagnosis of substance abuse disorder.
Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder
Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.