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To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.
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 in the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX AC1 on exercise capacity and respiratory quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Group A Anastomotic Coupler | Experimental | Device: ROX Anastomotic Coupler System (ACS). The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arteriovenous Fistula (ROX AC1) | Device | The percutaneous creation of an arteriovenous fistula. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in exercise capacity. | 12 weeks post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in quality of life. | 12 weeks post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claus Vogelmeier, MD | Universitätsklinikum Gieβen und Marburg, Standort Marburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Gieβen und Marburg, Standort Marburg | Marburg | D-35043 | Germany |
| 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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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008171 | Lung Diseases |
| D029481 | Bronchitis, Chronic |
| 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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| ID | Term |
|---|---|
| D001166 | Arteriovenous Shunt, Surgical |
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
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