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.

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

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.

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