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LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009) (CROSSOVER)

Primary Purpose

Emphysema

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
LVRC System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema

Eligibility Criteria

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

Inclusion Criteria:

  1. Subject was enrolled as a Control Subject in and completed all required study assessments through the 12 month visit for the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009.
  2. Subject has post-bronchodilator FEV1 ≤45% predicted.
  3. Subject has residual volume (RV) ≥175% predicted.
  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.
  5. Subject has read, understood and signed the Informed Consent form.
  6. Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy.

Exclusion Criteria:

  1. Subject has severe homogeneous emphysema as determined by the Core Radiology Lab
  2. 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.
  3. Subject has a change in FEV1 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator, unless investigator can confirm by other means that subject does not have asthma.
  4. Subject has DLCO <20% of predicted.
  5. Subject has severe gas exchange abnormalities as defined by:

    PaCO2 >55 mm Hg PaO2 <45 mm Hg on room air (High altitude criterion: PaO2 <30 mm Hg)

  6. Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
  7. Subject has severe pulmonary hypertension. If pulmonary hypertension is present, "severe" is defined by right ventricular systolic pressure >50 mm Hg via right heart catheterization and/or echocardiogram.
  8. Subject has an inability to walk >140 meters (150 yards) in 6 minutes.
  9. 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.
  10. Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
  11. Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
  12. Subject has clinically significant bronchiectasis.
  13. Subject has giant bullae >1/3 lung volume.
  14. Subject has had previous LVR surgery, lung transplantation, lobectomy, LVR devices or other devices to treat COPD in either lung.
  15. Subject has been involved in pulmonary drug or device studies within 30 days prior to this study, with the exception of the RENEW Study.
  16. Subject is taking >20 mg prednisone (or equivalent dose of a similar steroid) daily.
  17. Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
  18. Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped for seven (7) days prior to procedure.
  19. Subject has a sensitivity or allergy to nitinol (nickel-titanium) or its constituent metals.
  20. Subject has a known sensitivity to drugs required to perform bronchoscopy.
  21. Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).
  22. 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.

    -

Sites / Locations

  • University of Alabama Lung Health Center
  • Cedars Sinai Medical Center
  • El Camino Hospital/Palo Alto Medical Foundation
  • Yale University School of Medicine - Yale New Haven Hospital
  • University of Florida
  • Northwestern University
  • Illinois Lung and Critical Care Institute
  • 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
  • University Medical Center Groningen
  • Royal Brompton Hospital & Chelsea Westminster

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LVRC System

Arm Description

Outcomes

Primary Outcome Measures

Mean Change in Six Minute Walk Test (6MWT)
Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.

Secondary Outcome Measures

Mean Percent Change in Forced Expiratory Volume in One Second (FEV1)
The forced expiratory volume in one second (FEV1) measurement shows the amount of air a person can forcefully exhale in one second. Typically, lower FEV1 scores show more severe stages of lung disease. A positive change in FEV1 indicates improvement in lung function.
Mean Change in Residual Volume (RV)
Residual volume is the amount of air that remains in a person's lungs after fully exhaling. A decrease in residual volume indicates improvement in patients with higher residual volume measures.
Mean Change in St. Georges Respiratory Questionnaire (SGRQ)
Measure Description: The SGRQ is designed to measure health impairment in patients with asthma and COPD. It consists of 50 items and has two parts: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale) Scores range from 0 to 100, with higher scores indicating more limitations. A negative change in score indicates improvement, with a mean change of 4 points being the minimal important difference.

Full Information

First Posted
February 6, 2014
Last Updated
July 15, 2021
Sponsor
Boston Scientific Corporation
Collaborators
PneumRx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02059057
Brief Title
LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009)
Acronym
CROSSOVER
Official Title
Crossover From IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study, IDE G110066
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
FDA approval of supplementation to IDE/protocol amendment to terminate subject long term follow up
Study Start Date
December 2013 (Actual)
Primary Completion Date
June 2017 (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
Crossover study for patients who were randomized to the Control Group in CLN0009 (NCT01608490).
Detailed Description
Provide LVRC procedure to qualifying subjects who were enrolled as Control Subjects in and completed the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009, and obtain safety and effectiveness data on these patients.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LVRC System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LVRC System
Primary Outcome Measure Information:
Title
Mean Change in Six Minute Walk Test (6MWT)
Description
Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Time Frame
Change in Baseline to 12 months
Secondary Outcome Measure Information:
Title
Mean Percent Change in Forced Expiratory Volume in One Second (FEV1)
Description
The forced expiratory volume in one second (FEV1) measurement shows the amount of air a person can forcefully exhale in one second. Typically, lower FEV1 scores show more severe stages of lung disease. A positive change in FEV1 indicates improvement in lung function.
Time Frame
Change in Baseline to 12 months
Title
Mean Change in Residual Volume (RV)
Description
Residual volume is the amount of air that remains in a person's lungs after fully exhaling. A decrease in residual volume indicates improvement in patients with higher residual volume measures.
Time Frame
Change in Baseline to 12 months
Title
Mean Change in St. Georges Respiratory Questionnaire (SGRQ)
Description
Measure Description: The SGRQ is designed to measure health impairment in patients with asthma and COPD. It consists of 50 items and has two parts: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale) Scores range from 0 to 100, with higher scores indicating more limitations. A negative change in score indicates improvement, with a mean change of 4 points being the minimal important difference.
Time Frame
Change in Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject was enrolled as a Control Subject in and completed all required study assessments through the 12 month visit for the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009. Subject has post-bronchodilator FEV1 ≤45% predicted. Subject has residual volume (RV) ≥175% predicted. 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 read, understood and signed the Informed Consent form. Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy. Exclusion Criteria: Subject has severe homogeneous emphysema as determined by the 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 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator, unless investigator can confirm by other means that subject does not have asthma. Subject has DLCO <20% of predicted. Subject has severe gas exchange abnormalities as defined by: PaCO2 >55 mm Hg PaO2 <45 mm Hg on room air (High altitude criterion: PaO2 <30 mm 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 has severe pulmonary hypertension. If pulmonary hypertension is present, "severe" is defined by right ventricular systolic pressure >50 mm Hg via right heart catheterization and/or echocardiogram. Subject has an inability to walk >140 meters (150 yards) 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, LVR devices or other devices to treat COPD in either lung. Subject has been involved in pulmonary drug or device studies within 30 days prior to this study, with the exception of the RENEW Study. Subject is taking >20 mg 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 seven (7) days prior to procedure. 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). 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. -
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
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
Illinois Lung and Critical Care Institute
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61606
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
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
3150-3610536
Country
Netherlands
Facility Name
Royal Brompton Hospital & Chelsea Westminster
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009)

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