Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-26 @ 7:51 PM
Study NCT ID:
NCT02918305
Status:
COMPLETED
Last Update Posted:
2021-11-19
First Post:
2016-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension
Sponsor:
JIMRO Co., Ltd.
Organization:
Study Overview
Official Title:
A Clinical Study of the Ultrasound Renal Denervation System in Patients With Resistant Hypertension
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REQUIRE
Brief 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: