RecruitingNot ApplicableNCT05326230

A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)

A Clinical Study of the Ultrasound Renal Denervation System (PRDS-001) in Patients With Hypertension

Sponsor

Otsuka Medical Devices Co., Ltd. Japan

Enrollment

154 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Hypertension Vascular Diseases

Summary

To compare the antihypertensive effect of renal denervation with the Paradise™ system with that of a sham procedure in hypertensive patients receiving two antihypertensive drugs at the time of consent, and treated with a duo combination antihypertensive pill.

Eligibility

Min Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests the Paradise renal denervation system — a catheter procedure that uses ultrasound to reduce nerve signals to the kidneys — as a way to lower blood pressure in patients with difficult-to-control hypertension. **You may be eligible if...** - You have hypertension that is not controlled despite taking 2 or more blood pressure medications - You are 18 or older - Your kidneys are functioning adequately - You are willing to undergo a catheter-based procedure **You may NOT be eligible if...** - You have secondary hypertension caused by a treatable condition (e.g., kidney artery narrowing) - You have had prior kidney artery procedures - You have severe kidney disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEParadise™ (PRDS-001) Renal Denervation Ultrasound System

Following renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control

DEVICERenal Angiogram

Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure

Locations(51)

Hirosaki University Hospital

Hirosaki-shi, Aomori, Japan

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu-shi, Chiba, Japan

Ehime University Hospital

Toon-shi, Ehime, Japan

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, Japan

Fukuoka Sanno Hospital

Fukuoka, Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Iwaki City Medical Center

Iwaki, Fukushima, Japan

Chuno Kousei Hospital

Seki-shi, Gifu, Japan

Hiroshima City North Medical Center Asa Citizens Hospital

Hiroshima, Hiroshima, Japan

Nayoro City General Hospital

Nayoro-shi, Hokkaido, Japan

Sapporo-Kosei General Hospital

Sapporo, Hokkaido, Japan

Tonan Hospital

Sapporo, Hokkaido, Japan

Tomakomai City Hospital

Tomakomai-shi, Hokkaido, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Nishinomiya Municipal Central Hospital

Nishinomiya-Shi, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, Japan

Saiseikai Yokohamashi Nanbu Hospital

Yokohama, Kanagawa, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Yokohama Rosai Hospital

Yokohama, Kanagawa, Japan

Chikamori Hospital

Kochi, Kochi, Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Suzuka Chuo General Hospital

Suzuka-Shi, Mie-ken, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, Japan

Niigata City General Hospital

Niigata, Niigata, Japan

Okayama Rosai Hospital

Okayama, Okayama-ken, Japan

Ryukyu University Hospital

Naha, Okinawa, Japan

Osaka Saiseikai Nakatsu Hospital

Osaka, Osaka, Japan

Osaka Rosai Hospital

Sakai-shi, Osaka, Japan

National Cerebral and Cardiovascular Center

Suita-shi, Osaka, Japan

Osaka University Hospital

Suita-shi, Osaka, Japan

Imamura Hospital

Tosu-shi, Saga-ken, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, Japan

Mitsui Memorial Hospital

Chiyoda-ku, Tokyo, Japan

St. Luke's International Hospital

Cyuo-ku, Tokyo, Japan

Minamino Junkanki Hospital

Hachioji-shi, Tokyo, Japan

Kimura Clinic

Meguro-Ku, Tokyo, Japan

Toho University Medical Center Ohashi Hospital

Meguro-ku, Tokyo, Japan

Tokyo Saiseikai Central Hospital

Minato-ku, Tokyo, Japan

Tokyo Takanawa Hospital

Minato-ku, Tokyo, Japan

Toranomon Hospital

Minato-ku, Tokyo, Japan

Japanese Red Cross Musashino Hospital

Musashino-shi, Tokyo, Japan

Tokyo Rosai Hospital

Ōta-ku, Tokyo, Japan

Nissan Tamagawa Hospital

Setagaya-ku, Tokyo, Japan

Sanin Rosai Hospital

Yonago-shi, Tottori, Japan

Nihonkai General Hospital

Sakata-shi, Yamagata, Japan

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NCT05326230

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A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(51)

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