Clinical trial NCT02059057: LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009)
Official title: Crossover From IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study, IDE G110066
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Emphysema
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: PneumRx, Inc.
First posted: 2014-02-11
Enrollment: 102
Sex: ALL
Minimum age (years): 36
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: Mean Change in Six Minute Walk Test (6MWT)
timeFrame: Change in Baseline to 12 months
Secondary outcomes:
measure: Mean Percent Change in Forced Expiratory Volume in One Second (FEV1)
timeFrame: Change in Baseline to 12 months
measure: Mean Change in Residual Volume (RV)
timeFrame: Change in Baseline to 12 months
measure: Mean Change in St. Georges Respiratory Questionnaire (SGRQ)
timeFrame: Change in Baseline to 12 months
Other outcomes:
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: 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: Peoria
country: United States
facility: Illinois Lung and Critical Care Institute
state: Illinois
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: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: London
country: United Kingdom
facility: Royal Brompton Hospital & Chelsea Westminster
Study officials:
References: