Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema

• Register: ClinicalTrials.gov
• Last refreshed on: 8 May 2023
• Main ID: NCT03360396
• Date of registration: 22/11/2017
• Prospective Registration: Yes
• Primary sponsor: Boston Scientific Corporation
• Public title: Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema ELEVATE
• Scientific title: A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema
• Date of first enrolment: May 7, 2018
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03360396
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, France, Germany, Italy, Netherlands, Switzerland, United Kingdom

Contacts

• Name: Arschang Valipour, MD,FCCP,PhD
• Affiliation: Nord-Klinik Floridsdorf

• Name: Felix Herth, MD,
• Affiliation: University Hospital Heidelberg

Key inclusion & exclusion criteria

Inclusion Criteria:

- Read, understood and signed the Informed Consent form

- Meets indications for use per the IFU

- Bilateral heterogeneous and/or homogeneous emphysema

- Post bronchodilator 15% predicted = Forced Expiratory Volume in 1 second (FEV1) = 45%
predicted

- Post bronchodilator Residual Volume (RV) = 200% predicted

- Post bronchodilator Total Lung Capacity (TLC) >100% pred.

- Post bronchodilator RV/TLC > 55%

- Dyspnea related to hyperinflation scored = 2 on modified Medical Research Council
(mMRC) dyspnea scale despite optimal medical management

- Receiving optimal drug therapy and medical management according to clinical practice.

- Performing regular physical activity, at least 2 times per week

- Stopped smoking as confirmed by carboxyhemoglobin (CoHB)

- 100m = 6 minute walk distance (6MWD) = 450m

- Deemed eligible per Eligibility Review Committee (ERC)

- if treated in France, subject must be entitled to French social security.

Exclusion Criteria:

- Known sensitivity to drugs required for performing bronchoscopy or in whom
bronchoscopic procedures are contraindicated

- Evidence of active infection in the lungs

- Hypersensitivity or allergy to nitinol (nickel-titanium) or its constituent metals

- Clinical significant pulmonary fibrosis

- Clinically significant, generalized bronchiectasis

- Clinically significant bleeding disorders

- Patient taking immunosuppresive drugs other than steroids (e.g., for the treatment of
cancer, rheumatoid arthritis, autoimmune disease, or prevention of tissue or organ
rejection).

- Primary diagnosis of asthma

- 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 recommendations .

- 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)

- Percent Low Attenuation Area (%LAA) < 20% in the most damaged lobe of either lung.

- Computed Tomography (CT) Imaging consistent with active pulmonary infection,
significant interstitial disease or pleural disease

- Severe bullous disease (defined by bulla > 8cm or 1/3 of lung volume, or single
bullous defect >8 cm) or predominant paraseptal emphysema [defined by numerous large
(>1cm) paraseptal defects in the target lobe comprising of >5% of total lung volume].

- Lung pathology of nodule not proven stable or benign

- Radiographic confirmation of atelectasis or other scarring/fibrosis in areas of
intended Coil implant

- Use of more than 20 mg/day prednisolone or equivalent dosage of a different
corticosteroid

- Severe pulmonary hypertension (Right Ventricular Systolic Pressure (RVSP) > 50 mm Hg
or other signs of Pulmonary Hypertension (PHT) with right ventricular dysfunction)

- 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)

- Previous Lung Volume Reduction (LVR) surgery, lung transplantation, lobectomy, LVR
devices or other device to treat COPD in either lung.

- Diagnosed with alpha-1 antitrypsin deficiency

- Diffusion Capacity of the lungs for Carbon Monoxide (DLCO) < 20 %

- 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.

- Body Mass Index (BMI) > 30

- Participation in any other clinical Study.

- Subject is pregnant or lactating, or plan to become pregnant within the study
timeframe.

- If treated in France, Subject is a "personne vulnerable" as defined by French
Regulation



Age minimum: 35 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Emphysema

Intervention(s)

Device: Endobronchial Coils

Primary Outcome(s)

Percent Change in FEV1 at 6 Months [Time Frame: 6 months]

Absolute Change in SGRQ Score at 6 Months [Time Frame: 6 months]

Secondary ID(s)

BTG-004517-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PneumRx, Inc.

Results

• Results available: Yes
• Date Posted: 03/11/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03360396