Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2013-03-31
2019-12-31
Brief Summary
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* METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone.
* EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lung volume reduction coïl treatment
Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention
Lung volume reduction coïl treatment
Regular medical treatment
Regular Medical Treatment
No intervention, just a follow up under usual medical treatment
Regular medical treatment
Interventions
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Lung volume reduction coïl treatment
Regular medical treatment
Eligibility Criteria
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Inclusion Criteria
* Post bronchodilator FEV1 \< 50 %
* Total Lung Capacity \> 100 %
* Residual Volume \> 220 %
* Dyspnea score between 2 and 4 based on the mMRC scale
* Stopped cigarette smoking for more than 8 weeks
* Pulmonary rehabilitation within the previous twelve months
* Consent form signed
* Covered by Medical Insurance
Exclusion Criteria
* Post-bronchodilator change in FEV1 \> 20%
* Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months
* COPD exacerbation requiring hospital stay within 3 months
* Pulmonary Hypertension (Pulmonary systolic pressure \>50 mmHg on cardiac echo)
* Patient unable to perform a 6-min walking test in room air
* Giant bulla of more than 1/3 of the lung field on Chest CT
* Strictly homogeneous emphysema on Chest CT
* Clinically significant bronchiectasis
* Past history of lobectomy, lung volume reduction surgery, lung transplantation
* Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…)
* Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
* Contra-indication to general anesthesia
* Oral anticoagulant treatment (antivitamin K)
* Allergy to nitinol
* Inclusion in an other study assessing respiratory treatments
* Patient protected by the law
18 Years
ALL
No
Sponsors
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PneumRx, Inc.
INDUSTRY
CHU de Reims
OTHER
Responsible Party
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Principal Investigators
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Gaëtan DESLEE, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Reims
Locations
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CHU d'Amiens
Amiens, , France
CHU de Grenoble
Grenoble, , France
AP-HM
Marseille, , France
CHU de Montpellier
Montpellier, , France
CHU de Nice
Nice, , France
AP-HP - Hôpital Bichat
Paris, , France
CHU de Rouen
Rouen, , France
CHU de Saint-Etienne
Saint-Priest-en-Jarez, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Countries
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References
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Deslee G, Barbe C, Bourdin A, Durand-Zaleski I, Dutau H, Jolly D, Jounieaux V, Kessler R, Mal H, Pison C, Thiberville L, Vergnon JM, Marquette CH. [Cost-effectiveness of lung volume reduction coil treatment in emphysema. STIC REVOLENS]. Rev Mal Respir. 2012 Nov;29(9):1157-64. doi: 10.1016/j.rmr.2012.09.010. Epub 2012 Oct 12. French.
Perotin JM, Leroy S, Marquette CH, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Barbe C, Deslee G; REVOLENS Study Group. Endobronchial coil treatment in severe emphysema patients with alpha-1 antitrypsin deficiency. Int J Chron Obstruct Pulmon Dis. 2018 Nov 5;13:3645-3649. doi: 10.2147/COPD.S176366. eCollection 2018.
Bulsei J, Leroy S, Perotin JM, Mal H, Marquette CH, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaun M, Marceau A, Dukic S, Barbe C, Bonnaire M, Deslee G, Durand-Zaleski I; REVOLENS study group. Cost-effectiveness of lung volume reduction coil treatment in patients with severe emphysema: results from the 2-year follow-up crossover REVOLENS study (REVOLENS-2 study). Respir Res. 2018 May 9;19(1):84. doi: 10.1186/s12931-018-0796-x.
Deslee G, Leroy S, Perotin JM, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaun M, Marceau A, Dury S, Benzaquen J, Bonnaire M, Dukic S, Barbe C, Marquette CH; , on behalf of the REVOLENS Study Group13; REVOLENS Study Group. Two-year follow-up after endobronchial coil treatment in emphysema: results from the REVOLENS study. Eur Respir J. 2017 Dec 21;50(6):1701740. doi: 10.1183/13993003.01740-2017. Print 2017 Dec. No abstract available.
Deslee G, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Thiberville L, Leroy S, Marceau A, Laroumagne S, Mallet JP, Dukic S, Barbe C, Bulsei J, Jolly D, Durand-Zaleski I, Marquette CH; REVOLENS Study Group. Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):175-84. doi: 10.1001/jama.2015.17821.
Other Identifiers
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PD12133
Identifier Type: -
Identifier Source: org_study_id