EmphysemaRENEWNCT01608490
Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
A study testing RePneu Lung Volume Reduction Coil System in people with Emphysema, run by Boston Scientific Corporation at 29 sites in 6 countries.
Trial summary
Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- RePneu Lung Volume Reduction Coil System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 29 sitesin 6 countries
- Study dates
- Oct 2012to 26 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
United States23 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, 21237
University of Alabama Lung Health Center
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425-6300
Northwestern University
Chicago, Illinois, 60611
University of Illinois Hospital and Health Center
Chicago, Illinois, 60612
The Cleveland Clinic
Cleveland, Ohio, 44195
National Jewish Health
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida
Gainesville, Florida, 32610
Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital
Houston, Texas, 77030
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, 53792
El Camino Hospital/Palo Alto Medical Foundation
Mountain View, California, 94040
Yale University School of Medicine - Yale New Haven Hospital
New Haven, Connecticut, 06510
New York Presbyterian Columbia University Medical Center
New York, New York, 10032
Illinois Lung and Critical Care Institute
Peoria, Illinois, 61606
Temple
Philadelphia, Pennsylvania, 19140
Emphysema COPD Research Center, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229-3900
Franciscan Research Center
Tacoma, Washington, 98405
France2 sites
Centre Hospitalier Universitaire de Nice
Nice, CS 51069
CHU de Reims - Hopital Maison Blanche
Reims, 51092
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec
United Kingdom1 site
Royal Brompton Hospital & Chelsea Westminster
London, SW3 6NP
About this study
Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System
Read the detailed description
This will be a prospective, multicenter, randomized, assessor-blinded, controlled study comparing outcomes between the LVRC and Control Groups. Subjects will be block randomized in an LVRC (Treatment) to Control ratio of 1:1. The randomization will be stratified by homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the LVRC and Control Groups.
- Conditions
- Emphysema
- Being tested
- RePneu Lung Volume Reduction Coil System
- Keywords
- COPD, RePneu
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RePneu Lung Volume Reduction Coil SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RePneu Lung Volume Reduction Coil System | Experimental | 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. Receives: Device: RePneu Lung Volume Reduction Coil System |
| Control arm is standard medical care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meters: 6 Minute Walk Test - Change From Baseline to 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)
Measured: baseline through 12 months follow up
Secondary outcomes (3)
Mean Percent Change in FEV1 From Baseline to 12 Months
Mean percent change in FEV1(Forced Expiratory Volume in 1 second) at 12 months (median if skewed)
Measured: BL to 12 months
St. George's Respiratory Questionnaire (SGRQ) Mean Absolute Change From Baseline 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.
Measured: BL to 12 months
6MWT Responder Analysis
6MWT Responder Analysis: Responder is defined as those with an improvement of greater than or equal to 25 meters
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2015
- Study completion26 Jul 2019
Why it stopped: FDA approval of supplementation to IDE to terminate subject long term follow up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group received standard of care and LVRC and the control group received only standard of care.
- Masking
- None (open label)
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Responsible party
- Sponsor
- Investigators
- Charlie Strange, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608490
- Sponsor's protocol ID
- CLN0009
- Acronym
- RENEW
- Status last verified
- Jul 2021
- First submitted
- 26 May 2012
- Last updated
- 19 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Hartman JE, Shah PL, Sciurba F, Herth FJF, Slebos DJ; RENEW Study Group. Endobronchial coils for emphysema: Dual mechanism of action on lobar residual volume reduction. Respirology. 2020 Nov;25(11):1160-1166. doi: 10.1111/resp.13816. Epub 2020 Apr 8.
PubMed 32267059Slebos DJ, Cicenia J, Sciurba FC, Criner GJ, Hartman JE, Garner J, Deslee G, Delage A, Jantz M, Marquette CH, Strange C, Hatipoglu U, Mehta AC, LaPrad AS, Schmid-Bindert G, Herth FJF, Shah PL; RENEW Study Group. Predictors of Response to Endobronchial Coil Therapy in Patients With Advanced Emphysema. Chest. 2019 May;155(5):928-937. doi: 10.1016/j.chest.2019.02.012. Epub 2019 Feb 21.
PubMed 30797746Sciurba FC, Criner GJ, Strange C, Shah PL, Michaud G, Connolly TA, Deslee G, Tillis WP, Delage A, Marquette CH, Krishna G, Kalhan R, Ferguson JS, Jantz M, Maldonado F, McKenna R, Majid A, Rai N, Gay S, Dransfield MT, Angel L, Maxfield R, Herth FJ, Wahidi MM, Mehta A, Slebos DJ; RENEW Study Research Group. Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial. JAMA. 2016 May 24-31;315(20):2178-89. doi: 10.1001/jama.2016.6261.
PubMed 27179849
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study
- ClinicalTrials.gov ID
- NCT01608490
- Acronym / sponsor ID
- RENEW / CLN0009
- Conditions
- Emphysema
- Keywords
- COPD, RePneu
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA approval of supplementation to IDE to terminate subject long term follow up
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Study start
- Oct 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Posted 27 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System
Detailed description
This will be a prospective, multicenter, randomized, assessor-blinded, controlled study comparing outcomes between the LVRC and Control Groups. Subjects will be block randomized in an LVRC (Treatment) to Control ratio of 1:1. The randomization will be stratified by homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the LVRC and Control Groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group received standard of care and LVRC and the control group received only standard of care.
| Arm | Type | Receives |
|---|---|---|
| RePneu Lung Volume Reduction Coil System | Experimental | Device: RePneu Lung Volume Reduction Coil SystemThe 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. |
| Control arm is standard medical care | No intervention | –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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RePneu Lung Volume Reduction Coil SystemThe 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. | Device | RePneu Lung Volume Reduction Coil System |
Primary outcome
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)
3 secondary outcomes
Mean Percent Change in FEV1 From Baseline to 12 Months
Time frame: BL to 12 months
St. George's Respiratory Questionnaire (SGRQ) Mean Absolute Change From Baseline to 12 Months
Time frame: BL to 12 months
6MWT Responder Analysis
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32267059Hartman JE, Shah PL, Sciurba F, Herth FJF, Slebos DJ; RENEW Study Group. Endobronchial coils for emphysema: Dual mechanism of action on lobar residual volume reduction. Respirology. 2020 Nov;25(11):1160-1166. doi: 10.1111/resp.13816. Epub 2020 Apr 8.
- Derived from this study: PubMed 30797746Slebos DJ, Cicenia J, Sciurba FC, Criner GJ, Hartman JE, Garner J, Deslee G, Delage A, Jantz M, Marquette CH, Strange C, Hatipoglu U, Mehta AC, LaPrad AS, Schmid-Bindert G, Herth FJF, Shah PL; RENEW Study Group. Predictors of Response to Endobronchial Coil Therapy in Patients With Advanced Emphysema. Chest. 2019 May;155(5):928-937. doi: 10.1016/j.chest.2019.02.012. Epub 2019 Feb 21.
- Derived from this study: PubMed 27179849Sciurba FC, Criner GJ, Strange C, Shah PL, Michaud G, Connolly TA, Deslee G, Tillis WP, Delage A, Marquette CH, Krishna G, Kalhan R, Ferguson JS, Jantz M, Maldonado F, McKenna R, Majid A, Rai N, Gay S, Dransfield MT, Angel L, Maxfield R, Herth FJ, Wahidi MM, Mehta A, Slebos DJ; RENEW Study Research Group. Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial. JAMA. 2016 May 24-31;315(20):2178-89. doi: 10.1001/jama.2016.6261.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlie Strange, MD principal investigator
Medical University of South Carolina
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RePneu Lung Volume Reduction Coil System in people with Emphysema, run by Boston Scientific Corporation at 29 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, France, Canada, Germany, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meters: 6 Minute Walk Test - Change From Baseline to 12 Months Follow up (time frame: baseline through 12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01608490, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.