LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009)

NCT02059057 | Terminated Results DMC

• 1 other identifier: CLN0016
• Study Type: interventional
• Target: 102
• Locations: 5 countries
• Sites: 25

Brief Summary

Crossover study for patients who were randomized to the Control Group in CLN0009 (NCT01608490).

Conditions

Emphysema

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in Baseline to 12 months

Secondary Outcomes (3)

• Mean Percent Change in Forced Expiratory Volume in One Second (FEV1)

  Change in Baseline to 12 months

• Mean Change in Residual Volume (RV)

  Change in Baseline to 12 months

• Mean Change in St. Georges Respiratory Questionnaire (SGRQ)

  Change in Baseline to 12 months

Study Arms (1)

LVRC System

EXPERIMENTAL

Device: LVRC System

Interventions

LVRC System DEVICE

LVRC System

Eligibility Criteria

• Age: 36 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• PneumRx, Inc.: collaborator

Study Sites (25)

University of Alabama Lung Health Center

Birmingham, Alabama, 35294, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

El Camino Hospital/Palo Alto Medical Foundation

Mountain View, California, 94040, United States

Location

Yale University School of Medicine - Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Illinois Lung and Critical Care Institute

Peoria, Illinois, 61606, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York Presbyterian Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Temple

Philadelphia, Pennsylvania, 19140, United States

Location

Emphysema COPD Research Center, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-6300, United States

Location

Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

University of Texas Health Sciences Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Franciscan Research Center

Tacoma, Washington, 98405, United States

Location

University of Wisconsin School of Medicine & Public Health

Madison, Wisconsin, 53792, United States

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Québec, Canada

Location

Centre Hospitalier Universitaire de Nice

Nice, CS 51069, France

Location

CHU de Reims - Hopital Maison Blanche

Reims, 51092, France

Location

University Medical Center Groningen

Groningen, 3150-3610536, Netherlands

Location

Royal Brompton Hospital & Chelsea Westminster

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kristi Winterfeldt
• Organization: Boston Scientific

kristi.winterfeldt@bsci.com

+1 763-494-1165

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 11, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: July 26, 2019
• Last Updated: July 19, 2021
• Results First Posted: September 25, 2018

Record last verified: 2021-07

Locations

GB (1); FR (2); CA (1); NL (1); US (20)