NCT01682057CompletedPhase 2
A Prospective, Non-Randomized, Open Label, Multi-Center Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients With Severe Hypertension
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- ROX Medical, Inc.
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Change in mean office SBP
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination
Exclusion Criteria
- •Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.
Arms & Interventions
Group A
Experimental
ROX Anastomic Coupler System (ACS) + continuing standard antihypertensive medications
Intervention: ROX ANASTOMOTIC COUPLER SYSTEM (ACS) (Device)
Outcomes
Primary Outcomes
Change in mean office SBP
Time Frame: Baseline, 6 months
Change in mean office SBP at six months as compared to Baseline
Secondary Outcomes
- Change in mean office DBP(Change in mean office DBP six months as compared to Baseline)
Investigators
Study Sites (1)
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