The purpose of this study is to evaluate the safety and preliminary performance of the ROX Anastomotic Coupler System (ACS), with standard of care (as defined per GOLD) in patients with Chronic Obstructive Pulmonary Disease (COPD) as compared to standard of care alone.
Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease that leads to irreversible changes in the lung structure, but also to systemic changes in the body that can influence the severity of the disease. The irreversible changes to the lungs can be seen in limitations to the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX percutaneous Anastomotic Coupler System.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein)
Pulmonary Associates
Phoenix, Arizona, United States
UCLA Medical Center
Los Angeles, California, United States
Orlando Regional Health Care System
Orlando, Florida, United States
Sarasota Memorial Hospital
Improvement in exercise capacity.
Time frame: 3mo, 6mo, and 12mo
Incidence of complications and adverse events.
Time frame: 3mo, 6mo, and 12mo
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Sarasota, Florida, United States
Veritas Clinical Specialties, LTD
Topeka, Kansas, United States
Franklin Square Hospital
Baltimore, Maryland, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Oklahoma State University Medical Center
Tulsa, Oklahoma, United States