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

Phase 3

• Conditions: Primary Hypertension
• Interventions: Procedure: Sham procedure; Device: Renal Denervation System (AngioCare)

• Registration Number: NCT02901704
• Lead Sponsor: Shanghai AngioCare Medical

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.

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-14
• Last Update Submitted: 2016-09-14
• Study First Posted: 2016-09-15
• Last Update Posted: 2016-09-15
• Study Start: 2016-12
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham procedure	Sham procedure	Renal anigography
renal denervation	Renal Denervation System (AngioCare)	Iberis Multielectrode Renal Denervation System (AngioCare)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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