Clinical trial NCT00992680: A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
Official title: A Prospective, Randomized, Multicenter, Open Label, Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Lung Disease
Chronic Airflow Obstruction
Chronic Bronchitis
Pulmonary Emphysema
Walk
Lead sponsor: ROX Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in exercise capacity.
timeFrame: 3mo, 6mo, and 12mo
Secondary outcomes:
measure: Incidence of complications and adverse events.
timeFrame: 3mo, 6mo, and 12mo
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Orlando
country: United States
facility: Orlando Regional Health Care System
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Topeka
country: United States
facility: Veritas Clinical Specialties, LTD
state: Kansas
city: Baltimore
country: United States
facility: Franklin Square Hospital
state: Maryland
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Tulsa
country: United States
facility: Oklahoma State University Medical Center
state: Oklahoma
Study officials:
References:
citation: Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD. 2008 Dec;5(6):376-81. doi: 10.1080/15412550802522783.
citation: 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.