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Lung Volume Reduction Coil Treatment in Emphysema. (STICREVOLENS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01822795
Recruitment Status : Unknown
Verified April 2014 by CHU de Reims.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2013
Last Update Posted : April 30, 2014
Sponsor:
Collaborator:
PneumRx, Inc.
Information provided by (Responsible Party):
CHU de Reims

Study Description
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Brief Summary:
  • BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema.
  • 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.

Condition or disease Intervention/treatment Phase
Emphysema Procedure: Lung volume reduction coïl treatment Other: Regular medical treatment Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.
Study Start Date : March 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lung volume reduction coïl treatment
Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention
 Procedure: Lung volume reduction coïl treatment
Other: Regular medical treatment
Regular Medical Treatment
No intervention, just a follow up under usual medical treatment
 Other: Regular medical treatment


Outcome Measures
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Primary Outcome Measures :
  1. 6-month improvement of the 6-minute walk test [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Cost-effectiveness [ Time Frame: 6 and 12 months ]
    Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores.

  2. Dyspnea [ Time Frame: 6 and 12 months ]
    Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale

  3. Pulmonary function assessment [ Time Frame: 6 and 12 months ]
    Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC.

  4. Quality of life [ Time Frame: 6 and 12 months ]
    Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions)

  5. Morbidity-mortality [ Time Frame: 6 and 12 months ]
    Comparison of mortality and severe adverse events using a composite score (death, haemoptysis > 150 cc, pneumonia requiring hospitalization, pneumothorax requiring chest tube drainage > 7 days, mechanical ventilation > 24 hours, lung transplantation).


Other Outcome Measures:
  1. Exercise testing [ Time Frame: 6 and 12 months months ]
    Comparison of the 6-min walking test between groups (using the > 25 meters change from baseline as cut-off for clinically significant change).

  2. Exercise testing [ Time Frame: 12 months ]
    Comparison of the 6-min walking distance at 12 months using 54 meters as cut-off for clinically significant change.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral emphysema on Chest CT Scanner
  • 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 FEV1 < 15%
  • 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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01822795


Locations
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France
CHU d'Amiens
AMIENS Cedex 1, France, 80054
CHU de Grenoble
GRENOBLE Cedex 9, France, 38043
AP-HM
Marseille, France, 13015
CHU de Montpellier
MONTPELLIER Cedex 5, France, 34295
CHU de Nice
Nice, France, 06002
AP-HP - Hôpital Bichat
PARIS Cedex 18, France, 75877
CHU de Rouen
ROUEN Cedex, France, 76031
CHU de Saint-Etienne
Saint-priest-en-jarez, France, 42270
Hôpitaux Universitaires de Strasbourg
STRASBOURG Cedex, France, 67091
Sponsors and Collaborators
CHU de Reims
PneumRx, Inc.
Investigators
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Principal Investigator: Gaëtan DESLEE, PhD, MD CHU de Reims
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT01822795    
Other Study ID Numbers: PD12133
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014
Keywords provided by CHU de Reims:
Chronic obstructive pulmonary disease
Endoscopic lung volume reduction
Additional relevant MeSH terms:
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Pulmonary Emphysema
Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
 Lung Diseases
Respiratory Tract Diseases
Chronic Disease
Disease Attributes