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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Anastomotic Coupler System + standard of care per GOLD |
|
| Group B | No Intervention | Standard of care per GOLD alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROX Anastomotic Coupler System (ACS) | Device | The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in exercise capacity. | 3mo, 6mo, and 12mo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications and adverse events. | 3mo, 6mo, and 12mo |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Phoenix | Arizona | 85006 | United States | ||
| UCLA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19353352 | Background | Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD. 2008 Dec;5(6):376-81. doi: 10.1080/15412550802522783. | |
| 24484754 | Derived | Faul J, Schoors D, Brouwers S, Scott B, Jerrentrup A, Galvin J, Luitjens S, Dolan E. Creation of an iliac arteriovenous shunt lowers blood pressure in chronic obstructive pulmonary disease patients with hypertension. J Vasc Surg. 2014 Apr;59(4):1078-83. doi: 10.1016/j.jvs.2013.10.069. Epub 2014 Jan 28. |
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| Los Angeles |
| California |
| 90095-1690 |
| United States |
| Orlando Regional Health Care System | Orlando | Florida | 32803 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Veritas Clinical Specialties, LTD | Topeka | Kansas | 66606 | United States |
| Franklin Square Hospital | Baltimore | Maryland | 21237 | United States |
| Caritas St. Elizabeth's Medical Center | Boston | Massachusetts | 02135-2997 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Oklahoma State University Medical Center | Tulsa | Oklahoma | 74127 | United States |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008171 | Lung Diseases |
| D029481 | Bronchitis, Chronic |
| D011656 | Pulmonary Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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