A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension
NCT01682057 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2015-01-29
Summary
The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.
Conditions
Interventions
- DEVICE
-
ROX ANASTOMOTIC COUPLER SYSTEM (ACS)
The ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
- DEVICE
-
ROX Anastomotic Coupler System (ACS)
Sponsors & Collaborators
-
ROX Medical, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2013-03-31
- Completion
- 2013-03-31
Countries
- Belgium
Study Locations
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