Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study

Emphysema Clinical Trial

— RENEW  

Official title:

Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01608490
• Other study ID #: CLN0009
• Status: Terminated
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

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