VAST

Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks

VAST [NCT02382614]

Description: VAST is a multicenter, prospective, randomized, controlled study designed to evaluate treatment of persistent air leak with the SVS as compared to standard chest tube drainage management and other standard-of-care interventions in the control group. Eligible subjects will be randomized to receive either Spiration Valves (investigational arm) or continue standard-of-care treatment (control arm). Once the air leak has resolved, Spiration Valves should be removed.

Device: Spiration Valve System

Primary Investigator: Lanka

Drug/Device Information
To evaluate treatment with the SVS (Spiration Valve System) as compared to standard chest tube drainage management and other standard-of-care interventions
The Spiration Valve is a 1-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope
The Spiration Valve also is designed to be removable, using a flexible bronchoscope and appropriate bronchoscopy tools
Valves are available in 5 mm, 6 mm, 7 mm, and 9 mm diameter sizes
Randomization - 1:1 allocation, treatment to control
The treatment group will have valves deployed to achieve leak isolation
The control group for this study will receive standard chest tube drainage management and standard-of-care interventions
Spiration, Inc.
Major Inclusion and Exclusion
An air leak ≥ 100 mL/min, as measured by a digital thoracic drainage system (DTDS)
Air leak present on at least the 5th day following origination
No air leak only on forced exhalation or cough
No sepsis
No pneumonia
No Acute respiratory distress syndrome (ARDS)
No primary pneumothorax
No prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement