Clinical trial NCT01608490: Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
Official title: Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Emphysema
Keywords: COPD
RePneu
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: PneumRx, Inc.
First posted: 2012-05-31
Enrollment: 315
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group received standard of care and LVRC and the control group received only standard of care.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Meters: 6 Minute Walk Test - Change From Baseline to 12 Months Follow up
timeFrame: baseline through 12 months follow up
Secondary outcomes:
measure: Mean Percent Change in FEV1 From Baseline to 12 Months
timeFrame: BL to 12 months
measure: St. George's Respiratory Questionnaire (SGRQ) Mean Absolute Change From Baseline to 12 Months
timeFrame: BL to 12 months
measure: 6MWT Responder Analysis
timeFrame: 12 months
Other outcomes:
measure: SGRQ Responder Analysis
timeFrame: 12 months
measure: Residual Volume (RV) Mean Absolute Difference in RV From Baseline to 12 Months
timeFrame: 12 months
measure: RV/TLC Mean Absolute Difference From Baseline to 12 Months
timeFrame: 12 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama Lung Health Center
state: Alabama
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Mountain View
country: United States
facility: El Camino Hospital/Palo Alto Medical Foundation
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine - Yale New Haven Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Center
state: Illinois
city: Peoria
country: United States
facility: Illinois Lung and Critical Care Institute
state: Illinois
city: Baltimore
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York Presbyterian Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Temple
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Emphysema COPD Research Center, University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center at San Antonio
state: Texas
city: Tacoma
country: United States
facility: Franciscan Research Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin School of Medicine & Public Health
state: Wisconsin
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
city: Reims
country: France
facility: CHU de Reims - Hopital Maison Blanche
city: Heidelberg
country: Germany
facility: Thoraxklinik University of Heidelberg
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: London
country: United Kingdom
facility: Royal Brompton Hospital & Chelsea Westminster
Study officials:
affiliation: Medical University of South Carolina
name: Charlie Strange, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.