Study Stopped
FDA approval of supplementation to IDE to terminate subject long term follow up
Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
RENEW
1 other identifier
interventional
315
6 countries
29
Brief Summary
Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedResults Posted
Study results publicly available
June 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2019
CompletedJuly 19, 2021
July 1, 2021
3.2 years
May 26, 2012
April 25, 2017
July 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Mean Percent Change in FEV1 From Baseline to 12 Months
BL to 12 months
St. George's Respiratory Questionnaire (SGRQ) Mean Absolute Change From Baseline to 12 Months
BL to 12 months
6MWT Responder Analysis
12 months
Other Outcomes (3)
SGRQ Responder Analysis
12 months
Residual Volume (RV) Mean Absolute Difference in RV From Baseline to 12 Months
12 months
RV/TLC Mean Absolute Difference From Baseline to 12 Months
12 months
Study Arms (2)
RePneu Lung Volume Reduction Coil System
EXPERIMENTALThe RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.
Control arm is standard medical care
NO INTERVENTIONThe Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Scientific Corporationlead
- PneumRx, Inc.collaborator
Study Sites (29)
University of Alabama Lung Health Center
Birmingham, Alabama, 35294, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
El Camino Hospital/Palo Alto Medical Foundation
Mountain View, California, 94040, United States
National Jewish Health
Denver, Colorado, 80206, United States
Yale University School of Medicine - Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
University of Florida
Gainesville, Florida, 32610, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois Hospital and Health Center
Chicago, Illinois, 60612, United States
Illinois Lung and Critical Care Institute
Peoria, Illinois, 61606, United States
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, 21237, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
New York Presbyterian Columbia University Medical Center
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Temple
Philadelphia, Pennsylvania, 19140, United States
Emphysema COPD Research Center, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-6300, United States
Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229-3900, United States
Franciscan Research Center
Tacoma, Washington, 98405, United States
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, 53792, United States
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, Canada
Centre Hospitalier Universitaire de Nice
Nice, CS 51069, France
CHU de Reims - Hopital Maison Blanche
Reims, 51092, France
Thoraxklinik University of Heidelberg
Heidelberg, D-69126, Germany
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Royal Brompton Hospital & Chelsea Westminster
London, SW3 6NP, United Kingdom
Related Publications (3)
Hartman JE, Shah PL, Sciurba F, Herth FJF, Slebos DJ; RENEW Study Group. Endobronchial coils for emphysema: Dual mechanism of action on lobar residual volume reduction. Respirology. 2020 Nov;25(11):1160-1166. doi: 10.1111/resp.13816. Epub 2020 Apr 8.
PMID: 32267059DERIVEDSlebos DJ, Cicenia J, Sciurba FC, Criner GJ, Hartman JE, Garner J, Deslee G, Delage A, Jantz M, Marquette CH, Strange C, Hatipoglu U, Mehta AC, LaPrad AS, Schmid-Bindert G, Herth FJF, Shah PL; RENEW Study Group. Predictors of Response to Endobronchial Coil Therapy in Patients With Advanced Emphysema. Chest. 2019 May;155(5):928-937. doi: 10.1016/j.chest.2019.02.012. Epub 2019 Feb 21.
PMID: 30797746DERIVEDSciurba FC, Criner GJ, Strange C, Shah PL, Michaud G, Connolly TA, Deslee G, Tillis WP, Delage A, Marquette CH, Krishna G, Kalhan R, Ferguson JS, Jantz M, Maldonado F, McKenna R, Majid A, Rai N, Gay S, Dransfield MT, Angel L, Maxfield R, Herth FJ, Wahidi MM, Mehta A, Slebos DJ; RENEW Study Research Group. Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial. JAMA. 2016 May 24-31;315(20):2178-89. doi: 10.1001/jama.2016.6261.
PMID: 27179849DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kristi Winterfeldt
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Charlie Strange, MD
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2012
First Posted
May 31, 2012
Study Start
October 1, 2012
Primary Completion
December 1, 2015
Study Completion
July 26, 2019
Last Updated
July 19, 2021
Results First Posted
June 27, 2017
Record last verified: 2021-07