CONTROL HTN-2: A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
Sponsor
ROX Medical, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02895386
Collaborator
(none)
30
13
2
25.3
2.3
0.1
Study Details
Study Description
Brief Summary
To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
Actual Study Start Date
:
Mar 22, 2017
Actual Primary Completion Date
:
May 1, 2019
Actual Study Completion Date
:
May 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Treatment Group A ROX Coupler implantation and continuing antihypertensive medications. |
Device: ROX Coupler
ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
|
| Sham Comparator: Control Group B Sham procedure and continuing current antihypertensive medications. |
Other: Sham procedure
Sham procedure + continuing current antihypertensive medications.
|
Outcome Measures
Primary Outcome Measures
- Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure [Baseline, 6 months]
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline
Secondary Outcome Measures
- Change in mean office systolic blood pressure [Baseline, 6 months]
Change in mean office systolic blood pressure at six months as compared to Baseline
Eligibility Criteria
Criteria
Ages Eligible for Study:
22 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardiology P.C. Research | Birmingham | Alabama | United States | 35211 |
| 2 | UAB Division of Cardiovascular Disease | Birmingham | Alabama | United States | 35294 |
| 3 | The Cardiac and Vascular Institute Research Foundation | Gainesville | Florida | United States | 32605 |
| 4 | Piedmont Heart Institute | Atlanta | Georgia | United States | 30309 |
| 5 | Prairie Education and Research Cooperative | Springfield | Illinois | United States | 62769 |
| 6 | Cardiology Associates Research | Tupelo | Mississippi | United States | 38801 |
| 7 | Northwell Health - North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 8 | Northwell Health - Lenox Hill Hospital | New York | New York | United States | 10075 |
| 9 | Duke University Hospital | Durham | North Carolina | United States | 27710 |
| 10 | The Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | United States | 45219 |
| 11 | The MetroHealth System | Cleveland | Ohio | United States | 44109 |
| 12 | OhioHealth Research Institute | Columbus | Ohio | United States | 43214 |
| 13 | CAMC Clinical Trials Center | Charleston | West Virginia | United States | 25304 |
Sponsors and Collaborators
- ROX Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Lobo MD, Ott C, Sobotka PA, Saxena M, Stanton A, Cockcroft JR, Sulke N, Dolan E, van der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Scott B, Ng GA, Schmieder RE. Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN Trial. Hypertension. 2017 Dec;70(6):1099-1105. doi: 10.1161/HYPERTENSIONAHA.117.10142. Epub 2017 Oct 23.
- Lobo MD, Sobotka PA, Stanton A, Cockcroft JR, Sulke N, Dolan E, van der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Scott B, Ng GA, Ott C, Schmieder RE; ROX CONTROL HTN Investigators. Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial. Lancet. 2015 Apr 25;385(9978):1634-41. doi: 10.1016/S0140-6736(14)62053-5. Epub 2015 Jan 23. Erratum in: Lancet. 2016 Feb 13;387(10019):648. Erratum in: Lancet. 2015 Apr 25;385(9978):1622. Erratum in: Lancet. 2016 Feb 13;387(10019):648.
Responsible Party:
ROX Medical, Inc.
ClinicalTrials.gov Identifier:
NCT02895386
Other Study ID Numbers:
- US HTN-01
First Posted:
Sep 9, 2016
Last Update Posted:
May 13, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by ROX Medical, Inc.
Additional relevant MeSH terms: