Renal Denervation by Iberis MultiElectrode Renal Denervation System in Patients With Primary Hypertension (Iberis-HTN)

Shanghai AngioCare Medical

Status and phase

Unknown

Phase 3

Conditions

Primary Hypertension

Treatments

Procedure: Sham procedure

Device: Renal Denervation System (AngioCare)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02901704

AT201601

Details and patient eligibility

About

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

Full 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.

Enrollment

216 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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 Exclusion Criteria:

Known secondary hypertension
Type 1 diabetes mellitus
Has an implantable cardioverter defibrillator (ICD) or pacemaker
Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
Has hemodynamically significant valvular heart disease
Pregnant, nursing, or planning to be pregnant
Any serious medical condition that may adversely affect the safety of the participant or the study
Currently enrolled in another investigational drug or device trial

2.Angiographic Exclusion Criteria
Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
History of prior renal artery intervention including balloon angioplasty or stenting
Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney
Main renal arteries with <3 mm diameter or with <20 mm treatable length (by visual estimation)
Renal artery abnormalities