Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
NCT ID: NCT01608490
Last Updated: 2021-07-19
Study Results
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View full resultsBasic Information
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TERMINATED
NA
315 participants
INTERVENTIONAL
2012-10-31
2019-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RePneu Lung Volume Reduction Coil System
The 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.
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.
Control arm is standard medical care
The 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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
35 Years
ALL
No
Sponsors
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PneumRx, Inc.
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Charlie Strange, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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University of Alabama Lung Health Center
Birmingham, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
El Camino Hospital/Palo Alto Medical Foundation
Mountain View, California, United States
National Jewish Health
Denver, Colorado, United States
Yale University School of Medicine - Yale New Haven Hospital
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois Hospital and Health Center
Chicago, Illinois, United States
Illinois Lung and Critical Care Institute
Peoria, Illinois, United States
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
New York Presbyterian Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Temple
Philadelphia, Pennsylvania, United States
Emphysema COPD Research Center, University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital
Houston, Texas, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, United States
Franciscan Research Center
Tacoma, Washington, United States
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, United States
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, , Canada
Centre Hospitalier Universitaire de Nice
Nice, , France
CHU de Reims - Hopital Maison Blanche
Reims, , France
Thoraxklinik University of Heidelberg
Heidelberg, , Germany
University Medical Center Groningen
Groningen, , Netherlands
Royal Brompton Hospital & Chelsea Westminster
London, , United Kingdom
Countries
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References
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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.
Slebos 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.
Sciurba 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.
Other Identifiers
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CLN0009
Identifier Type: -
Identifier Source: org_study_id
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