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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01608490
Other study ID # CLN0009
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 2012
Est. completion date July 26, 2019

Study information

Verified date July 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System


Description:

This will be a prospective, multicenter, randomized, assessor-blinded, controlled study comparing outcomes between the LVRC and Control Groups. Subjects will be block randomized in an LVRC (Treatment) to Control ratio of 1:1. The randomization will be stratified by homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the LVRC and Control Groups.


Recruitment information / eligibility

Status Terminated
Enrollment 315
Est. completion date July 26, 2019
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 35 Years and older
Eligibility Inclusion Criteria: - Subject is greater than or equal to 35 yrs of age - CT Scan indicates bilateral emphysema, as determined by the Core Radiology Lab using the criteria presented in the "CT Scoring Plan for Core Radiology Lab" - Subject has post-bronchodilator FEV1 less than or equal to 45% predicted - Subject has Total Lung Capacity >100% predicted - Subject has residual volume (RV) greater than or equal to 175% predicted - Subject has marked dyspnea greater than or equal to 2 on mMRC scale of 0-4 - Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by a Cotinine test or other appropriate diagnostic test. - Subject has completed a pulmonary rehabilitation program within 6 mos prior to treatment and/or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 mos prior to baseline testing. - Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy. - Subject (and legal guardian, if applicable) has read, understood, and signed the Informed Consent form. Exclusion Criteria: - Subject has severe homogeneous emphysema determined by Core Radiology Lab. - 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 on 6MWT is not due to dyspnea. - Subject has a change in FEV1 of greater than 20% (or, for subjects with pre-bronchodilator FEV1 below 1L, a change of greater than 200mL) post-bronchodilator unless investigator can confirm by other means that subject does not have asthma. - Subject has DLCO of less than 20% of predicted. - Subject has severe gas exchange abnormalities, PaCO2 of greater than 55mm Hg; PaO2 of less than 45 mm Hg on room air (high altitude criterion: PaO2 of less than 30mm Hg). - Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment. - Subject as severe pulmonary hypertension defined by right ventricular systolic pressure of greater than 50mm Hg via right heart catheterization and/or echocardiogram - Subject has an inability to walk >140m (150 yd) in 6 minutes - 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. - Subject is pregnant or lactating, or plans to become pregnant within the study timeframe. - Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia. - Subject has clinically significant bronchiectasis. - Subject has giant bullae >1/3 lung volume - Subject has had previous LVR surgery, lung transplantation, lobectomy or LVR devices or other device to treat COPD in either lung. - Subject has been involved in pulmonary drug or device studies within 30 days prior to this study. - Subject is taking >20mg prednisone (or equivalent dose of a similar steroid) daily. - Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder. - Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as Heparin or Coumadin) which cannot be stopped for 7 days prior to the procedure. - 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. - Subject has a sensitivity or allergy to nitinol (nickel-titanium) or its constituent metals. - Subject has a known sensitivity to drugs required to perform bronchoscopy. - Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
RePneu Lung Volume Reduction Coil System
The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

Locations

Country Name City State
Canada Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) Quebec
France Centre Hospitalier Universitaire de Nice Nice
France CHU de Reims - Hopital Maison Blanche Reims
Germany Thoraxklinik University of Heidelberg Heidelberg
Netherlands University Medical Center Groningen Groningen
United Kingdom Royal Brompton Hospital & Chelsea Westminster London
United States University of Michigan Health System Ann Arbor Michigan
United States Pulmonary and Critical Care Associates of Baltimore Baltimore Maryland
United States University of Alabama Lung Health Center Birmingham Alabama
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States Northwestern University Chicago Illinois
United States University of Illinois Hospital and Health Center Chicago Illinois
United States The Cleveland Clinic Cleveland Ohio
United States National Jewish Health Denver Colorado
United States Duke University Medical Center Durham North Carolina
United States University of Florida Gainesville Florida
United States Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital Houston Texas
United States Cedars Sinai Medical Center Los Angeles California
United States University of Wisconsin School of Medicine & Public Health Madison Wisconsin
United States El Camino Hospital/Palo Alto Medical Foundation Mountain View California
United States Yale University School of Medicine - Yale New Haven Hospital New Haven Connecticut
United States New York Presbyterian Columbia University Medical Center New York New York
United States Illinois Lung and Critical Care Institute Peoria Illinois
United States Temple Philadelphia Pennsylvania
United States Emphysema COPD Research Center, University of Pittsburgh Pittsburgh Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States University of Texas Health Sciences Center at San Antonio San Antonio Texas
United States Franciscan Research Center Tacoma Washington

Sponsors (2)

Lead Sponsor Collaborator
Boston Scientific Corporation PneumRx, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other SGRQ Responder Analysis SGRQ Responder Analysis: Responder defined as those with an improvement greater than or equal to 4 points 12 months
Other Residual Volume (RV) Mean Absolute Difference in RV From Baseline to 12 Months Mean absolute difference in RV results measured using plethysmography, comparing BL to 12 months, LVRC vs. Control 12 months
Other RV/TLC Mean Absolute Difference From Baseline to 12 Months Mean absolute difference in RV/TLC (residual volume/total lung capacity - a measure done during lung function testing where residual volume is air left over in lung after completely breathing out and total lung capacity is how much air the lung can breathe in) results measured using plethysmography, comparing BL to 12 months, LVRC vs. Control 12 months
Primary Meters: 6 Minute Walk Test - Change From Baseline to 12 Months Follow up mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups (median if skewed) baseline through 12 months follow up
Secondary Mean Percent Change in FEV1 From Baseline to 12 Months Mean percent change in FEV1(Forced Expiratory Volume in 1 second) at 12 months (median if skewed) BL to 12 months
Secondary St. George's Respiratory Questionnaire (SGRQ) Mean Absolute Change From Baseline to 12 Months mean absolute difference in SGRQ results comparing BL to 12 months, LVRC vs. Control, score is on a scale from 0 to 100, negative change will be a better outcome. BL to 12 months
Secondary 6MWT Responder Analysis 6MWT Responder Analysis: Responder is defined as those with an improvement of greater than or equal to 25 meters 12 months
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