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

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

Study Overview

• Status: Unknown
• Conditions: Primary Hypertension
• Intervention / Treatment: Device: Renal Denervation System (AngioCare); Procedure: Sham procedure

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 Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: renal denervation; Iberis Multielectrode Renal Denervation System (AngioCare)	Device: Renal 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.
Sham Comparator: Sham procedure; Renal anigography	Procedure: Sham 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Shanghai AngioCare Medical

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: AT201601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided