Clinical trial NCT01642498: A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension
Official title: ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients With Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: High Blood Pressure
Hypertension
Resistant Hypertension
Lead sponsor: ROX Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of treatment-resistant 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.

Primary outcomes:
measure: Change in mean office SBP
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in mean office DBP
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA - Cardio Middleheim
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin - Campus Benjamin Franklin
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Marburg
country: Germany
facility: Hypertoniezentrum Marburg
city: Athens
country: Greece
facility: G. Gennimatas General Hospital of Athens
city: Athens
country: Greece
facility: Hippokration General Hospital of Athens
city: Blanchardstown
country: Ireland
facility: Connolly Hospital
state: Dublin
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Krakow
country: Poland
facility: Jagiellonian University Collegium Medicum
city: Warsaw
country: Poland
facility: Institute of Cardiology - Warsaw
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
state: England
city: London
country: United Kingdom
facility: Queen Mary University of London
state: England
city: London
country: United Kingdom
facility: Royal Bromptom
state: England
city: Carshalton
country: United Kingdom
facility: St. Helier Hospital
state: Surrey England
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Wales
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester - Glenfield Hospital
Study officials:
References:
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.
citation: Ott C, Lobo MD, Sobotka PA, Mahfoud F, Stanton A, Cockcroft J, Sulke N, Dolan E, van der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Saxena M, Scott B, Ng GA, Achenbach S, Schmieder RE. Effect of Arteriovenous Anastomosis on Blood Pressure Reduction in Patients With Isolated Systolic Hypertension Compared With Combined Hypertension. J Am Heart Assoc. 2016 Dec 21;5(12):e004234. doi: 10.1161/JAHA.116.004234.
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: Foran JP, Jain AK, Casserly IP, Kandzari DE, Rocha-Singh KJ, Witkowski A, Katzen BT, Deaton D, Balmforth P, Sobotka PA. The ROX coupler: creation of a fixed iliac arteriovenous anastomosis for the treatment of uncontrolled systemic arterial hypertension, exploiting the physical properties of the arterial vasculature. Catheter Cardiovasc Interv. 2015 Apr;85(5):880-6. doi: 10.1002/ccd.25707. Epub 2014 Nov 1.