Clinical trial NCT02895386: A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
Official title: A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
High Blood Pressure
Keywords: Hypertension
High Blood Pressure
Systolic Blood Pressure
Uncontrolled Hypertension
Essential Hypertension
Resistant Hypertension
Vascular Disease
Lead sponsor: ROX Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in mean office systolic blood pressure
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology P.C. Research
state: Alabama
city: Birmingham
country: United States
facility: UAB Division of Cardiovascular Disease
state: Alabama
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute Research Foundation
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Tupelo
country: United States
facility: Cardiology Associates Research
state: Mississippi
city: Manhasset
country: United States
facility: Northwell Health - North Shore University Hospital
state: New York
city: New York
country: United States
facility: Northwell Health - Lenox Hill Hospital
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Charleston
country: United States
facility: CAMC Clinical Trials Center
state: West Virginia
Study officials:
References:
citation: 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.
citation: 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.