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NCT01885390 Clinical Trial

Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension

Hypertension Clinical Trial

Official title:
ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01885390
Other study ID # RH-03
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 1, 2014
Est. completion date May 5, 2019

Study information
Verified date May 2019
Source ROX Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date May 5, 2019
Est. primary completion date May 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Diagnosis of resistant or uncontrolled 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 registry, comply with follow-up requirements, or impact the scientific integrity of the study.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ROX COUPLER
The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein).

Locations
Country Name City State
Belgium ZNA Cardio Middelheim Antwerp
Netherlands St. Antonius Ziekenhuis Nieuwegein
United Kingdom East Sussex Healthcare NHS Trust Eastbourne
United Kingdom Queen Mary University of London London

Sponsors (1)
Lead Sponsor Collaborator
ROX Medical, Inc.

Countries where clinical trial is conducted

Belgium,  Netherlands,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in ambulatory daytime mean systolic blood pressure Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline. Baseline, 6 months
Secondary Change in ambulatory daytime mean diastolic blood pressure Change in mean ambulatory daytime diastolic blood pressure at six months as compared to Baseline. Baseline, 6 months
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