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

Primary Purpose

Emphysema

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RePneu Lung Volume Reduction Coil System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring COPD, RePneu

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Alabama Lung Health Center
  • Cedars Sinai Medical Center
  • El Camino Hospital/Palo Alto Medical Foundation
  • National Jewish Health
  • Yale University School of Medicine - Yale New Haven Hospital
  • University of Florida
  • Northwestern University
  • University of Illinois Hospital and Health Center
  • Illinois Lung and Critical Care Institute
  • Pulmonary and Critical Care Associates of Baltimore
  • Beth Israel Deaconess Medical Center
  • University of Michigan Health System
  • Mayo Clinic
  • New York Presbyterian Columbia University Medical Center
  • Duke University Medical Center
  • The Cleveland Clinic
  • Temple
  • Emphysema COPD Research Center, University of Pittsburgh
  • Medical University of South Carolina
  • Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital
  • University of Texas Health Sciences Center at San Antonio
  • Franciscan Research Center
  • University of Wisconsin School of Medicine & Public Health
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
  • Centre Hospitalier Universitaire de Nice
  • CHU de Reims - Hopital Maison Blanche
  • Thoraxklinik University of Heidelberg
  • University Medical Center Groningen
  • Royal Brompton Hospital & Chelsea Westminster

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RePneu Lung Volume Reduction Coil System

Control arm is standard medical care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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.
6MWT Responder Analysis
6MWT Responder Analysis: Responder is defined as those with an improvement of greater than or equal to 25 meters

Full Information

First Posted
May 26, 2012
Last Updated
July 15, 2021
Sponsor
Boston Scientific Corporation
Collaborators
PneumRx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01608490
Brief Title
Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
Acronym
RENEW
Official Title
Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
FDA approval of supplementation to IDE to terminate subject long term follow up
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
July 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
PneumRx, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
Keywords
COPD, RePneu

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group received standard of care and LVRC and the control group received only standard of care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RePneu Lung Volume Reduction Coil System
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm is standard medical care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
RePneu Lung Volume Reduction Coil System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Meters: 6 Minute Walk Test - Change From Baseline to 12 Months Follow up
Description
mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups (median if skewed)
Time Frame
baseline through 12 months follow up
Secondary Outcome Measure Information:
Title
Mean Percent Change in FEV1 From Baseline to 12 Months
Description
Mean percent change in FEV1(Forced Expiratory Volume in 1 second) at 12 months (median if skewed)
Time Frame
BL to 12 months
Title
St. George's Respiratory Questionnaire (SGRQ) Mean Absolute Change From Baseline to 12 Months
Description
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.
Time Frame
BL to 12 months
Title
6MWT Responder Analysis
Description
6MWT Responder Analysis: Responder is defined as those with an improvement of greater than or equal to 25 meters
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
SGRQ Responder Analysis
Description
SGRQ Responder Analysis: Responder defined as those with an improvement greater than or equal to 4 points
Time Frame
12 months
Title
Residual Volume (RV) Mean Absolute Difference in RV From Baseline to 12 Months
Description
Mean absolute difference in RV results measured using plethysmography, comparing BL to 12 months, LVRC vs. Control
Time Frame
12 months
Title
RV/TLC Mean Absolute Difference From Baseline to 12 Months
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlie Strange, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Lung Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
El Camino Hospital/Palo Alto Medical Foundation
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Yale University School of Medicine - Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois Hospital and Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Illinois Lung and Critical Care Institute
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61606
Country
United States
Facility Name
Pulmonary and Critical Care Associates of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
New York Presbyterian Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Temple
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Emphysema COPD Research Center, University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-6300
Country
United States
Facility Name
Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Sciences Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Franciscan Research Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
University of Wisconsin School of Medicine & Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
City
Quebec
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Nice
City
Nice
ZIP/Postal Code
CS 51069
Country
France
Facility Name
CHU de Reims - Hopital Maison Blanche
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Thoraxklinik University of Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69126
Country
Germany
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Royal Brompton Hospital & Chelsea Westminster
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32267059
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.
Results Reference
derived
PubMed Identifier
30797746
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.
Results Reference
derived
PubMed Identifier
27179849
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.
Results Reference
derived

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

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