Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Lung Disease, Chronic Airflow Obstruction, Chronic Bronchitis, Pulmonary Emphysema, Walk
Brief summary
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.
Detailed description
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.
Interventions
The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein)
Sponsors
ROX Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.
Exclusion criteria
* Subjects not meeting Stage III or IV Chronic Obstructive Pulmonary Disease (COPD) * Subjects with significant comorbidities * Subjects not qualifying because of physical or psychological condition that may put them at risk of participating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in exercise capacity. | 3mo, 6mo, and 12mo |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of complications and adverse events. | 3mo, 6mo, and 12mo |
Countries
United States
Outcome results
None listed