Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2016 by ROX Medical, Inc.
Sponsor:
ROX Medical, Inc.
Information provided by (Responsible Party):
ROX Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01885390
First received: June 20, 2013
Last updated: September 15, 2016
Last verified: September 2016
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Purpose
The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Blood Pressure, High Blood Pressure, Resistant Blood Pressure, Uncontrolled |
Device: ROX COUPLER |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension |
Further study details as provided by ROX Medical, Inc.:
Primary Outcome Measures:
- Change in ambulatory daytime mean systolic blood pressure [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline.
Secondary Outcome Measures:
- Change in ambulatory daytime mean diastolic blood pressure [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]Change in mean ambulatory daytime diastolic blood pressure at six months as compared to Baseline.
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2014 |
| Estimated Study Completion Date: | June 2019 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental: Group A
ROX Coupler + continuing standard antihypertensive medications
|
Device: ROX COUPLER
The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01885390
Please refer to this study by its ClinicalTrials.gov identifier: NCT01885390
Locations
| Belgium | |
| ZNA Cardio Middelheim | Recruiting |
| Antwerp, Belgium, 2020 | |
| Contact: Benjamin Scott, MD +32 3 280 32 09 | |
| Contact: Martine Oreglia, RN +32 3 280 32 09 mi.stusec-cardiologie@xna.be | |
| Netherlands | |
| St. Antonius Ziekenhuis | Recruiting |
| Nieuwegein, Netherlands, 3435CM | |
| Contact: Benno J. Rensing, MD +31 30 609 3267 b.rensing@antoniusziekenhuis.nl | |
| Contact: Manfred Oostveen, RN +31 30 609 3267 ch.oostveen@antoniusziekenhuis.nl | |
| United Kingdom | |
| East Sussex Healthcare NHS Trust | Recruiting |
| East Sussex, United Kingdom, BN21 2UD | |
| Contact: Steve Furniss, MD steve.furniss@esht.nhs.uk | |
| Contact: Sarah Bridgland, BS sarah.bridgland@esht.uk | |
| Queen Mary University of London | Recruiting |
| London, United Kingdom, EC1M 6BQ | |
| Contact: Mel Lobo, MD 020 7882 3416 m.d.lobo@qmul.ac.uk | |
| Contact: Anne Zak, RN 020 7882 5660 a.zak@qmul.ac.uk | |
| Principal Investigator: Mel Lobo, MD | |
Sponsors and Collaborators
ROX Medical, Inc.
Investigators
| Principal Investigator: | Mel Lobo, MD | Queen Mary University of London |
More Information
| Responsible Party: | ROX Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01885390 History of Changes |
| Other Study ID Numbers: | RH-03 |
| Study First Received: | June 20, 2013 |
| Last Updated: | September 15, 2016 |
| Health Authority: | England: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by ROX Medical, Inc.:
|
Hypertension High blood pressure Resistant blood pressure Uncontrolled blood pressure |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on September 30, 2016