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

Last updated: September 14, 2016
Sponsor: Shanghai AngioCare Medical
Overall Status: Trial Status Unknown

Phase

3

Condition

High Blood Pressure (Hypertension)

High Blood Pressure (Hypertension - Pediatric)

Stress

Treatment

N/A

Clinical Study ID

NCT02901704
AT201601
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 - 65 years

  • Primary Hypertension

  • Stable medication regimen including 3 antihypertensive medications of differentclasses, including a diuretic (with no changes for a minimum of 4 weeks prior toscreening) and 1) Office SBP ≥150 and ≤180 mmHg, and DBP ≥90 , 2) average 24-hourambulatory systolic blood pressue and/or DBP ≥135 and ≤170 mmHg

  • Main renal arteries with ≥3 mm diameter or with ≥20 mm treatable length (by visualestimation)

  • Written informed consent

Exclusion

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 cerebrovascularaccident 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 participantor 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 thekidney

  • Main renal arteries with <3 mm diameter or with <20 mm treatable length (by visualestimation)

  • Renal artery abnormalities

Study Design

Total Participants: 216
Study Start date:
December 01, 2016
Estimated Completion Date:
December 31, 2018

Study 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.