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

Study Overview
=================
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.

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

Conditions
-----------------
Primary Hypertension

Intervention / Treatment
-----------------
* Device: Renal Denervation System (AngioCare)
* Procedure: Sham procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: renal denervation<br>Iberis Multielectrode Renal Denervation System (AngioCare) | Device: Renal Denervation System (AngioCare)<br>* After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.<br>|
| Sham Comparator: Sham procedure<br>Renal anigography | Procedure: Sham procedure<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |