Trials / Completed
CompletedNCT02918305
Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension
A Clinical Study of the Ultrasound Renal Denervation System in Patients With Resistant Hypertension
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- JIMRO Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc. Paradise in Europe) for renal denervation therapy in patients with treatment resistance hypertension, in comparison with the sham procedure.
Detailed description
Patients with treatment resistance hypertension is defined patients being treated on 3 or more different classes of antihypertensive medications including diuretics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PRDS-001 Renal Denervation Ultrasound System | |
| PROCEDURE | Sham Procedure |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2020-07-01
- Completion
- 2021-10-01
- First posted
- 2016-09-28
- Last updated
- 2021-11-19
Locations
53 sites across 2 countries: Japan, South Korea
Source: ClinicalTrials.gov record NCT02918305. Inclusion in this directory is not an endorsement.