Back to resultsStudy of the Effect of the ROX AC1 on Exercise Capacity and Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Arteriovenous Fistula (ROX AC1)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Lung Disease, Chronic Airflow Obstruction, Chronic Bronchitis, Chronic Emphysema
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:
- Subject not qualifying because of physical or psychological condition that may put them at risk of participating.
Sites / Locations
- Universitätsklinikum Gieβen und Marburg, Standort Marburg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: Group A Anastomotic Coupler
Arm Description
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).
Outcomes
Primary Outcome Measures
Improvement in exercise capacity.
Secondary Outcome Measures
Improvement in quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00832611
Brief Title
Study of the Effect of the ROX AC1 on Exercise Capacity and Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ROX Medical, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Lung Disease, Chronic Airflow Obstruction, Chronic Bronchitis, Chronic Emphysema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Group A Anastomotic Coupler
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Arteriovenous Fistula (ROX AC1)
Intervention Description
The percutaneous creation of an arteriovenous fistula.
Primary Outcome Measure Information:
Title
Improvement in exercise capacity.
Time Frame
12 weeks post-procedure
Secondary Outcome Measure Information:
Title
Improvement in quality of life.
Time Frame
12 weeks post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
Subject not qualifying because of physical or psychological condition that may put them at risk of participating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Vogelmeier, MD
Organizational Affiliation
Universitätsklinikum Gieβen und Marburg, Standort Marburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Gieβen und Marburg, Standort Marburg
City
Marburg
ZIP/Postal Code
D-35043
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
19353352
Citation
Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD. 2008 Dec;5(6):376-81. doi: 10.1080/15412550802522783.
Results Reference
background
PubMed Identifier
24484754
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.
Results Reference
derived
Learn more about this trial
Study of the Effect of the ROX AC1 on Exercise Capacity and Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients
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