A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
A Prospective, Randomized, Multicenter, Open Label, Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
49
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 chronic-obstructive-pulmonary-disease
Started Sep 2009
Longer than P75 for phase_2 chronic-obstructive-pulmonary-disease
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 7, 2009
CompletedFirst Posted
Study publicly available on registry
October 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 21, 2014
April 1, 2014
1.1 years
October 7, 2009
April 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in exercise capacity.
3mo, 6mo, and 12mo
Secondary Outcomes (1)
Incidence of complications and adverse events.
3mo, 6mo, and 12mo
Study Arms (2)
Group A
EXPERIMENTALAnastomotic Coupler System + standard of care per GOLD
Group B
NO INTERVENTIONStandard of care per GOLD alone
Interventions
The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein)
Eligibility Criteria
You may qualify if:
- Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Pulmonary Associates
Phoenix, Arizona, 85006, United States
UCLA Medical Center
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
Related Publications (2)
Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD. 2008 Dec;5(6):376-81. doi: 10.1080/15412550802522783.
PMID: 19353352BACKGROUNDFaul 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.
PMID: 24484754DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2009
First Posted
October 9, 2009
Study Start
September 1, 2009
Primary Completion
October 1, 2010
Study Completion
December 1, 2013
Last Updated
April 21, 2014
Record last verified: 2014-04