A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension
This study is currently recruiting participants.
Verified September 2012 by ROX Medical, Inc.
Sponsor:
ROX Medical, Inc.
Information provided by (Responsible Party):
ROX Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01682057
First received: September 5, 2012
Last updated: September 7, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS) Device: ROX Anastomotic Coupler System (ACS) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Non-Randomized, Open Label, Multi-Center Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients With Severe Hypertension |
Resource links provided by NLM:
Further study details as provided by ROX Medical, Inc.:
Primary Outcome Measures:
- Change in mean office SBP [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]Change in mean office SBP at six months as compared to Baseline
Secondary Outcome Measures:
- Change in mean office DBP [ Time Frame: Change in mean office DBP six months as compared to Baseline ] [ Designated as safety issue: No ]Change in mean office DBP at six months as compared to Baseline
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
ROX Anastomic Coupler System (ACS) + continuing standard antihypertensive medications
|
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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682057
Locations
| Belgium | |
| Universitair Ziekenhuis Brussel | Recruiting |
| Brussels, Belgium, 1090 | |
| Contact: Danny Schoors, Dr. +32 247 63 256 danny.schoors@uzbrussel.be | |
| Contact: Sofie Brouwers, Dr. +32 2 474 92 69 sofie.brouwers@vub.ac.be | |
| Principal Investigator: Danny Schoors, Dr. | |
Sponsors and Collaborators
ROX Medical, Inc.
More Information
No publications provided
| Responsible Party: | ROX Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01682057 History of Changes |
| Other Study ID Numbers: | RH-01 |
| Study First Received: | September 5, 2012 |
| Last Updated: | September 7, 2012 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by ROX Medical, Inc.:
|
High Blood Pressure Hypertension Resistant Hypertension |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013