Related Experiment Video
Updated: Feb 20, 2026
Improved Home Blood Pressure Control by CT-guided Ozone-mediated Renal Denervation for Patients with Resistant Hypertension
Published on: June 6, 2025
Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN
Melvin D Lobo1, Christian Ott2, Paul A Sobotka2
1From the NIHR Biomedical Research Centre at Barts, William Harvey Research Institute, London, United Kingdom (M.D.L., M.S.); Department of Nephrology and Hypertension, Friedrich-Alexander University Erlangen-Nürnberg, Germany (C.O.); Cardiovascular Medicine, Ohio State University, Columbus (P.A.S.); ROX Medical, Inc, San Clemente, CA (P.A.S.); Molecular and Cellular Therapeutics, Royal College of Surgeons in Ireland Medical School, Dublin (A.S.); Department of Cardiology, Columbia Presbyterian Hospital, New York, NY (J.R.C.); Cardiology Department, Eastbourne District General Hospital, East Sussex, United Kingdom (N.S.); Department of Medicine for the Elderly, Connolly Hospital, Dublin, Ireland (E.D.); Department of Endocinrology and Nephrology, Universitätsmedizin Berlin, Germany (M.v.d.G.); Department of Internal Medicine and Nephrology, Universitätsklinikum Marburg, Germany (J.H.); Department of Cardiology, East Sussex Healthcare NHS Trust, United Kingdom (S.S.F.); Cardiac Department, Royal Brompton Hospital, London, United Kingdom (J.P.F.); Cardiology Department, St Helier Hospital, Surrey, United Kingdom (J.P.F.); Department of Interventional Cardiology and Angiology (A.W.) and Department of Hypertension (A.J.), Institute of Cardiology, Warsaw, Poland; Department of Cardiology, Universitair Ziekenhuis Brussel, Belgium (D.S.); Department of Cardiology, Hippokration General Hospital of Athens, Greece (K.T.); Department of Cardiology, St Antonius Ziekenhuis, Nieuwegein, The Netherlands (B.J.R.); Department of Cardiology, ZNA-Cardio Middelheim, Antwerp, Belgium (B.S.); Department of Cardiovascular Sciences, NIHR Leicester Cardiovascular Biomedical Research Unit, University of Leicester, Glenfield Hospital, United Kingdom (G.A.N.); and Department of Nephrology and Hypertension, Universitätsklinikum Erlangen, Germany (R.E.S.). m.d.lobo@qmul.ac.uk.
Abstract:
Creation of a central iliac arteriovenous anastomosis using a novel nitinol coupler device results in an immediate, significant reduction of blood pressure (BP). We present efficacy and safety findings at 12 months post-coupler insertion. This open-label, multicenter, prospective, randomized trial enrolled patients with a baseline office systolic BP ≥140 mm Hg and average daytime ambulatory BP ≥135/85 mm Hg. Subjects were randomly allocated to coupler implantation and continuing previous pharmacotherapy or to maintain previous treatment alone. At 12 months, 39 patients who had coupler therapy were included in the intention-to-treat analysis. Office-based systolic BP reduced by 25.1±23.3 mm Hg (baseline, 174±18 mm Hg; P<0.0001) post-coupler placement, and office diastolic BP reduced by 20.8±13.3 mm Hg (baseline, 100±13 mm Hg; P<0.0001). Mean 24-hour ambulatory BP reduced by 12.6±17.4/15.3±9.7 mm Hg (P<0.0001 for both). In a prespecified subset of patients who failed to respond adequately to prior renal denervation, coupler therapy led to highly significant reduction in office systolic/diastolic BP (30.7/24.1 mm Hg) and significant reduction in 24-hour ambulatory systolic/diastolic BP (12.4/14.4 mm Hg) at 12 months (n=9). After coupler therapy, 14 patients (33%) developed ipsilateral venous stenosis; all were treated successfully with venous stenting. These findings confirm the importance of arterial mechanics in the pathophysiology of hypertension and support the clinical use of a central iliac arteriovenous anastomosis.
Clinical Trial Registration:
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01642498.
