LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009) (CROSSOVER)
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
First received: February 6, 2014
Last updated: February 10, 2014
Last verified: January 2014
Crossover study for patients who were randomized to the Control Group in CLN0009.
Device: LVRC System
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Crossover From IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study, IDE G110066
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
Experimental: LVRC System
Device: LVRC System
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.
|Ages Eligible for Study:
||36 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- 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 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 Nickel.
- 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.
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History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 6, 2014
||February 10, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases