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Bronchoscopische Longvolume Reductie door middel van éénrichtingsventielen in patiënten met ernstig COPD.


- candidate number9395
- NTR NumberNTR2876
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-apr-2011
- Secondary IDs80-82305-97-11018 ZonMW/VEMI
- Public TitleBronchoscopische Longvolume Reductie door middel van éénrichtingsventielen in patiënten met ernstig COPD.
- Scientific TitleBronchoscopic Lung Volume Reduction with endobronchial valves using best responder criteria in patients with severe COPD - The STELVIO trial.
- ACRONYMSTELVIO trial
- hypothesisPrimary Objective:
In this trial we will investigate the efficacy of BVR using best responder criteria in patients with severe heterogeneous emphysema compared to usual care.

Secondary Objective:
Economic evaluation: Estimation of costs of BVR compared to care as usual and (historical) costs of LVRS.
- Healt Condition(s) or Problem(s) studiedChronic Obstructive Pulmonary Disease (COPD), Emphysema
- Inclusion criteria1. Patient > 35 years of age;
2. CT scan indicates heterogeneous emphysema (>25% difference in destruction score between ipsilateral lobes);
3. CT shows ≥ 60% destruction of the target lobe;
4. CT scan indicates intact fissures as assessed on the sagittal reconstructions of a thin slice CT, or previously performed assessment of collateral flow show absence of collateral ventilation;
5. Post- bronchodilator FEV1 <60% predicted;
6. Post- bronchodilator TLC>100% en RV>150%;
7. Dyspnea score of ≥2 on the mMRC scale of 0-4;
8. Patient has stopped smoking for a minimum of 6 months prior to entering the study;
9. Signed informed Consent;
10. Subject is willing and able to comply with all study testing and procedures according to protocol and guidelines;
11. Lobar exclusion during EBV treatment is achieved.
- Exclusion criteria1. Hypercapnia defined by PaCO2>8.0 kPa, or hypoxemia defined by PaO2<6.0kPa, both measured on room air;
2. 6MWT <140 meters;
3. Previous LVR-surgery, lung transplantation or lobectomy;
4. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins) or has not been weaned off prior to procedure;
5. Involved in other pulmonary drug studies within 30 days prior to this study;
6. Evidence of other disease that may compromise survival, would interfere with completion of study, follow up assessments or that would adversely affect outcomes, such as lung cancer, and/or ASA class >III.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2011
- planned closingdate1-mei-2013
- Target number of participants28
- InterventionsBronchoscopic lung volume reduction using Zephyr one-way endobronchial valves (PulmonX USA).
There will be a crossover of the control group to treatment.
- Primary outcomeStatistical and clinical significant improvement in both the FVC and FEV1 as well as in the 6 minute walk test.
- Secondary outcomeEstimation of costs of BVR compared to care as usual and (historical) costs of LVRS.
- TimepointsFollow-up after treatment is 6 months, crossover for control is also after 6 months
- Trial web sitewww.bronchoscopie.umcg.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Karin Klooster
- CONTACT for SCIENTIFIC QUERIESDr. D.J. Slebos
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryTitle:
Bronchoscopic Lung Volume reduction with endobronchial valves using best responder criteria in patients with severe COPD: “STEVIO-trial”.

Primary Objective:
We will investigate the efficacy of BVR using best responder criteria in patients with severe heterogeneous emphysema compared to usual care.

Secondary Objective:
Economic evaluation: Estimation of costs of BVR compared to care as usual and (historical) costs of LVRS.

Study Design:
Prospective, randomized (1:1) clinical intervention single center trial with a crossover of the control group to treatment.

Study Population:
22 Patients with COPD Gold stage III-IV, who stopped smoking at least 6 months ago and who have severe dyspnea despite optimal medical treatment with heterogeneous distributed emphysema with intact interlobular fissures present on thin slice CT scan.

Device:
Zephyr (PulmonX, USA) endobronchial valve. Follow-Up 6 months, with crossover for the control group after 6 months to active treatment.

Duration:
24 months.

Primary endpoint:
Statistical and clinical significant improvement in both the FVC and FEV1 as well as in the 6 minute walk test.
- Main changes (audit trail)16-Jun-2011: MEC-approval received on 10-Jun-2011, target number of participants increased from 22 to 28 - NM
23-Mar-2013: Target number of participant increased to 68. Planned closingdate will be 01-May-2014 - NM
- RECORD28-apr-2011 - 3-feb-2015


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