Changes in Lung Physiology and Cardiac Performance in Patients With Emphysema Post Bilateral RePneu Coil Treatment

The objective of this post-marketing study is to advance the understanding of the mechanism of action of the CE marked RePneu Coil by observing changes in lung physiology and cardiac performance in patients with emphysema treated with the RePneu Coils, when used as intended.

Study Overview

• Status: Terminated
• Conditions: Emphysema
• Intervention / Treatment: Device: PneumRx Coil System

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Germany
  • Grosshansdorf, Germany
    • LungenClinic
  • Heidelberg, Germany
    • Thoraxklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult subjects diagnosed with emphysematous type of COPD

Description

Inclusion Criteria:

1. Adult subjects diagnosed with emphysematous type of COPD.
2. CT scan indicates bilateral emphysema, with sufficient lung parenchyma for coil deployment (based on PneumRx CT scoring) criteria.
3. Subject has post-bronchodilator FEV1 ≤45% predicted.
4. Subject has Total Lung Capacity >100% predicted.
5. Subject has residual volume (RV) ≥175% predicted.
6. Subject has marked dyspnea scoring ≥2 on mMRC scale of 0-4.
7. Subject read, understood and signed the Informed Consent form.
8. Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy.

Exclusion Criteria:

1. Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g. severe arthritis, planned knee surgery) or baseline limitation not due to dyspnea.
2. Subject has a change in FEV1 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator unless investigator can confirm by other means that subject does not have asthma.

3. Subject has severe gas exchange abnormalities as defined by:

   • PaCO2 >55 mm Hg
   • PaO2 <45 mm Hg on room air (High altitude criterion: PaO2 <30 mm Hg)
4. Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >50 mm Hg via right heart catheterization and/or echocardiogram.
5. Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study.
6. Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
7. Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
8. Subject has clinically significant bronchiectasis.
9. Subject has had previous LVR surgery, lung transplantation, lobectomy or other BLVR treatment in either lung.
10. Subject has participated in studies to treat COPD using high dose radiation.
11. Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
12. Subject is chronically taking >20 mg prednisone (or equivalent dose of a similar steroid) daily.
13. Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
14. Subject is on any type of antiplatelet or anticoagulant therapy which cannot be stopped for seven (7) days prior to procedure.
15. Subject has a sensitivity or allergy to Nickel.
16. Subject has a known sensitivity to drugs required to perform bronchoscopy.
17. Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).
18. Subject has any other disease, condition(s) or habit(s) that would interfere with completion of study and follow-up assessments, would increase risks of bronchoscopy or assessments, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment; Patients treated with PneumRx Coil System	Device: PneumRx Coil System; Other Names: LVRC; RePneu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in 6 Minute Walk Distance (6MWD)	Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 12 months after the initial treatment of the RePneu coil. 6MWD was measured in meters.	Baseline, 12 months post initial treatment
Changes in 6 Minute Walk Distance (6MWD)	Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 3 months after final treatment of the RePneu coil. 6MWD was measured in meters.	Baseline, 3 months post final treatment

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: PneumRx, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2015
• Primary Completion (Actual): December 8, 2017
• Study Completion (Actual): October 20, 2018

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: RePneu; Coil; LVRC; PneumRx
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: CLN0017