Renal Denervation by Iberis MultiElectrode Renal Denervation System in Patients With Primary Hypertension

A Prospective, Multi-centers, Randomized,Controlled, Blinded,Superiority Trial of Renal Denervation Using Iberis MultiElectrode Renal Denervation System for the Treatment of Primary Hypertension.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02901704

Acronym

Iberis-HTN

Enrollment

216

Registered

2016-09-15

Start date

2016-12-31

Completion date

2018-12-31

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypertension

Brief summary

The purpose of Iberis-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with primary hypertension by using Iberis multielectrode renal denervation system

Detailed description

The purpose was to evaluate 3-month outcomes of RDN for the treatment of primary hypertension in Chinese patients.In a prospective, multi-center study, 216 Chinese patients with primary hypertension would be recruited to undergo RDN by Iberis Multielectrode denervation system. The primary effectiveness endpoint wasReduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up.

Interventions

DEVICERenal Denervation System (AngioCare)

After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

PROCEDURESham procedure

After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 10 minutes prior to introducer sheath removal.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age 18 - 65 years * Primary Hypertension * Stable medication regimen including 3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and 1) Office SBP ≥150 and ≤180 mmHg, and DBP ≥90 , 2) average 24-hour ambulatory systolic blood pressue and/or DBP ≥135 and ≤170 mmHg * Main renal arteries with ≥3 mm diameter or with ≥20 mm treatable length (by visual estimation) * Written informed consent

Exclusion criteria

Clinical

Design outcomes

Primary

Measure	Time frame
Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up	3 months

Secondary

Measure	Time frame
Reduction in average 24-hour ambulatory systolic blood pressue at 6 months	6 months
Change in office systolic blood pressure	1 month,3 months,6 months and 12 months
Device or procedure related acute adverse events	1 month,3 months,6 months and 12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026