A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension

Hypertension Clinical Trial

Official title:

A Prospective, Non-Randomized, Open Label, Multi-Center Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients With Severe Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682057
• Other study ID #: RH-01
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2012
• Last updated: January 27, 2015
• Start date: October 2011
• Est. completion date: March 2013

Study information

• Verified date: January 2015
• Source: ROX Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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).
• ROX Anastomotic Coupler System (ACS)

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
ROX Medical, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean office SBP	Change in mean office SBP at six months as compared to Baseline	Baseline, 6 months	No
Secondary	Change in mean office DBP	Change in mean office DBP at six months as compared to Baseline	Change in mean office DBP six months as compared to Baseline	No