A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized, Multicenter, Open Label, Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: ROX Anastomotic Coupler System (ACS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Anastomotic Coupler System + standard of care per GOLD | Device: ROX Anastomotic Coupler System (ACS)<br>* The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein)<br>|
| No Intervention: Group B<br>Standard of care per GOLD alone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in exercise capacity. |  | 3mo, 6mo, and 12mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications and adverse events. |  | 3mo, 6mo, and 12mo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Disease, Chronic Airflow Obstruction, Chronic Bronchitis, Pulmonary Emphysema, Walk