Lung Volume Reduction Coil Treatment in Emphysema. (STICREVOLENS)

This study is currently recruiting participants.
Verified April 2013 by CHU de Reims
Sponsor:
Collaborator:
PneumRx, Inc.
Information provided by (Responsible Party):
CHU de Reims
ClinicalTrials.gov Identifier:
NCT01822795
First received: March 28, 2013
Last updated: April 3, 2013
Last verified: April 2013
  Purpose
  • 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 Intervention Phase
Emphysema
Procedure: Lung volume reduction coïl treatment
Other: Regular medical treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.

Resource links provided by NLM:


Further study details as provided by CHU de Reims:

Primary Outcome Measures:
  • 6-month improvement of the 6-minute walk test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Cost-effectiveness [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores.

  • Dyspnea [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale

  • Pulmonary function assessment [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC.

  • Quality of life [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions)

  • Morbidity-mortality [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
    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:
  • Exercise testing [ Time Frame: 6 and 12 months months ] [ Designated as safety issue: No ]
    Comparison of the 6-min walking test between groups (using the > 25 meters change from baseline as cut-off for clinically significant change).

  • Exercise testing [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Comparison of the 6-min walking distance at 12 months using 54 meters as cut-off for clinically significant change.


Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822795

Contacts
Contact: Gaëtan DESLEE, PhD, MD 326787611 ext 33 gdeslee@chu-reims.fr
Contact: Margaux VERDIER 326787767 ext 33 mverdier@chu-reims.fr

Locations
France
CHU d'Amiens Recruiting
AMIENS Cedex 1, France, 80054
Principal Investigator: Vincent JOUNIEAUX, PhD, MD         
CHU de Grenoble Recruiting
GRENOBLE Cedex 9, France, 38043
Principal Investigator: Christophe PISON, PhD, MD         
AP-HM Recruiting
Marseille, France, 13015
Principal Investigator: Hervé DUTAU, MD         
CHU de Montpellier Recruiting
MONTPELLIER Cedex 5, France, 34295
Principal Investigator: Arnaud BOURDIN, PhD, MD         
CHU de Nice Recruiting
Nice, France, 06002
Principal Investigator: Charles-Hugo MARQUETTE, PhD, MD         
AP-HP - Hôpital Bichat Recruiting
PARIS Cedex 18, France, 75877
Principal Investigator: Hevé MAL, PhD, MD         
CHU de Rouen Recruiting
ROUEN Cedex, France, 76031
Principal Investigator: Luc THIBERVILLE, PhD, MD         
CHU de Saint-Etienne Recruiting
Saint-priest-en-jarez, France, 42270
Principal Investigator: Jean-Michel VERGNON, PhD, MD         
Hôpitaux Universitaires de Strasbourg Recruiting
STRASBOURG Cedex, France, 67091
Principal Investigator: Romain KESSLER, PhD, MD         
Sponsors and Collaborators
CHU de Reims
PneumRx, Inc.
Investigators
Principal Investigator: Gaëtan DESLEE, PhD, MD CHU de Reims
  More Information

Additional Information:
Publications:
Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT01822795     History of Changes
Other Study ID Numbers: PD12133
Study First Received: March 28, 2013
Last Updated: April 3, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by CHU de Reims:
Chronic obstructive pulmonary disease
Endoscopic lung volume reduction

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014