Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, 634009, Russia
NCT Number: NCT02667912
Objective of this study is to evaluate whether a distal mode of endovascular renal denervation with the treatment performed primarily in segmental branches of renal artery is more effective than conventional mode of the intervention with the treatment equally distributed within its main trunk for the treatment of drug-resistant hypertension.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Tomsk, 634009, Russia
Recent spectacular failure of renal denervation (RDN) therapy in SymplicityHTN-3 trial in fact might be easily predicted from the very beginning. Conventional RDN done as 4-6 point treatments equally distributed within main trunk of renal artery (RA) may only be effective if renal plexus tightly surrounds the artery throughout its whole course with equal longitudinal and circumferential density of the nerve fibers. While this idea itself is unnaturally idealistic also a number of surgical studies demonstrated that proximally majority of renal nerves go at a distance from RA obliquely to its course and join the artery mainly in its distal part (fan-shaped renal plexus with wide base directed toward aorta and apex converging to renal gate). We developed a distal mode of RDN targeting segmental branches of RA and conducted a single-center double-blind randomized controlled parallel group study to compare its efficacy and safety to those of conventional RDN in patients with drug-resistant hypertension.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Percutaneous endovascular intervention when catheter-based electrode (Symplicity Flex; Medtronic, Inc.) is used for stepwise radiofrequency energy delivery to segmental branches of the renal artery in a number of points distributed along the length and circumference of the vessels in order to ablate renal nerve plexus
Percutaneous endovascular intervention when catheter-based electrode (Symplicity Flex; Medtronic, Inc.) is used for stepwise radiofrequency energy delivery to the main trunk of the renal artery in a number of points equally distributed along its length and circumference in order to ablate renal nerve plexus
Time frame: From baseline to 6 months
Time frame: From baseline to 6 months
Time frame: From baseline to 12 months
Time frame: From baseline to 6 months
Resistance index is calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry
Time frame: From baseline to 6 months
Resistance index calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry
Time frame: From baseline to 6 months
Time frame: From baseline to 12 months
Time frame: From baseline to 6 months
Time frame: From baseline to 12 months
Time frame: From baseline to 6 months
Time frame: From baseline to 12 months
Time frame: From baseline to 12 months
Time frame: From baseline to 6 months
Time frame: From baseline to 12 months
Time frame: From baseline to 6 months
Time frame: From baseline to 12 months
Time frame: From baseline to 6 months
Time frame: From baseline to 12 months
Time frame: From baseline to 6 months
Time frame: From baseline to 12 months
Time frame: From baseline to 6 months
Time frame: From baseline to 12 months
Time frame: From baseline to 6 months
Time frame: From baseline to 12 months
Tomsk National Research Medical Center of the Russian Academy of Sciences
Other
Anatomically Optimized Distal Renal Denervation for Treatment of Resistant Hypertension
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