Clinical trial NCT04256408: Mind The Gap - Crossing Borders Study
Official title: Bronchoscopic Conversion of Collateral Ventilation in CV-positive Emphysema Patients Before Endobronchial Valve Treatment - Mind The Gap Crossing Borders Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emphysema
COPD
Hyperinflation Lung
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Pulmonx Corporation
First posted: 2020-02-05
Enrollment: 3
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Rationale: A big step forward and great opportunity to improve overall efficacy of bronchoscopic lung volume reductioen is to combine treatment modalities aiming to close the dependent collateral channels and then proceed with EBV therapy to induce lobar collapse, and thus maximal treatment effect.

Objective:

Primary objective:

1. To investigate the feasibility of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.

   Secondary objectives:
2. To investigate the safety of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
3. To investigate the effectiveness of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of emphysema with a treatable target for endobronchial valves (Zephyr).
2. Subjects of both genders of at least 35 years of age at the time of the baseline visit.
3. Understand and voluntarily sign a patient informed consent form.
4. 15 % predicted ≤ FEV1 ≤ 50% predicted.
5. RV ≥ 175% predicted, and TLC ≥ 100% predicted and RV/TLC ≥ 55%.
6. 6MWD ≥ 140 meters.
7. Dyspnea score of ≥2 on the mMRC scale of 0-4.
8. Non-smoker \> 6 months prior to signing the informed consent.
9. Chartis CV positive between target and ipsilateral lobe

Exclusion Criteria:

1. Evidence of active pulmonary infection.
2. Evidence of clinically significant bronchiectasis.
3. History of more than 3 exacerbations with hospitalizations over the past 12 months.
4. Myocardial infarction or other relevant cardiovascular events in the past 6 months.
5. Prior lung surgery, Lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy.
6. Prior endoscopic lung volume reduction.
7. Unstable pulmonary nodule requiring follow-up
8. Pregnant of nursing women.
9. Hypercapnia defined by PaCO2 \> 8.0kPa, or Hypoxemia defined by PaO2 \< 6.0kPa, both measured on room air.
10. Any disease with high probability of mortality within 24 months.
11. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins), which cannot be stopped periprocedural.
12. Patient was involved in other pulmonary drug studies within 30 days prior to this study.

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Primary outcomes:
measure: feasibility - Target Lobar Volume Change on Chest -CT scan
timeFrame: 3 months
Secondary outcomes:
measure: safety - Number and specification of reported (S)AEs per individual patient and as aggregate
timeFrame: 3 months
measure: changes in Quality of Life as measured by the SGRQ
timeFrame: 3 months
measure: effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1).
timeFrame: 3 months
measure: effectiveness - Measurement of change in Residual Volume (RV)
timeFrame: 3 months
measure: effectiveness - Measurement of changes in 6-minute walk test (6MWT)
timeFrame: 3 months
measure: changes in Quality of Life as measured by the COPD Assessment Test (CAT)
timeFrame: 3 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: UMC-Groningen/NL
name: Karin Klooster, PhD
role: STUDY_DIRECTOR
References: