Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study (RENEW)
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|ClinicalTrials.gov Identifier: NCT01608490|
Recruitment Status : Terminated (FDA approval of supplementation to IDE to terminate subject long term follow up)
First Posted : May 31, 2012
Results First Posted : June 27, 2017
Last Update Posted : July 19, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Emphysema||Device: RePneu Lung Volume Reduction Coil System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||315 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||One group received standard of care and LVRC and the control group received only standard of care.|
|Masking:||None (Open Label)|
|Official Title:||Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||July 26, 2019|
Experimental: RePneu Lung Volume Reduction Coil System
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.
Device: RePneu Lung Volume Reduction Coil System
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.
No Intervention: Control arm is standard medical care
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.
- Meters: 6 Minute Walk Test - Change From Baseline to 12 Months Follow up [ Time Frame: baseline through 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)
- Mean Percent Change in FEV1 From Baseline to 12 Months [ Time Frame: BL 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 [ Time Frame: BL 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 [ Time Frame: 12 months ]6MWT Responder Analysis: Responder is defined as those with an improvement of greater than or equal to 25 meters
- SGRQ Responder Analysis [ Time Frame: 12 months ]SGRQ Responder Analysis: Responder defined as those with an improvement greater than or equal to 4 points
- Residual Volume (RV) Mean Absolute Difference in RV From Baseline to 12 Months [ Time Frame: 12 months ]Mean absolute difference in RV results measured using plethysmography, comparing BL to 12 months, LVRC vs. Control
- RV/TLC Mean Absolute Difference From Baseline to 12 Months [ Time Frame: 12 months ]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
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|Ages Eligible for Study:||35 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608490
|Principal Investigator:||Charlie Strange, MD||Medical University of South Carolina|
|Responsible Party:||Boston Scientific Corporation|
|Other Study ID Numbers:||
|First Posted:||May 31, 2012 Key Record Dates|
|Results First Posted:||June 27, 2017|
|Last Update Posted:||July 19, 2021|
|Last Verified:||July 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases