Study of the Effect of the ROX AC1 on Exercise Capacity and Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Study of the Effect of the ROX Percutaneous Arteriovenous Fistula System (ROX AC1) on Exercise Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
46
1 country
1
Brief Summary
To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 chronic-obstructive-pulmonary-disease
Started Nov 2008
Typical duration for phase_4 chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 28, 2009
CompletedFirst Posted
Study publicly available on registry
January 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedJanuary 29, 2015
January 1, 2015
2.3 years
January 28, 2009
January 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in exercise capacity.
12 weeks post-procedure
Secondary Outcomes (1)
Improvement in quality of life.
12 weeks post-procedure
Study Arms (1)
Experimental: Group A Anastomotic Coupler
EXPERIMENTALDevice: 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).
Interventions
The percutaneous creation of an arteriovenous fistula.
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:
- Subject 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 (1)
Universitätsklinikum Gieβen und Marburg, Standort Marburg
Marburg, D-35043, Germany
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claus Vogelmeier, MD
Universitätsklinikum Gieβen und Marburg, Standort Marburg
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2009
First Posted
January 30, 2009
Study Start
November 1, 2008
Primary Completion
March 1, 2011
Study Completion
November 1, 2011
Last Updated
January 29, 2015
Record last verified: 2015-01