NCT02901704

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

1.5 years

First QC Date

September 12, 2016

Last Update Submit

September 14, 2016

Conditions

Primary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up

    3 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

renal denervation

EXPERIMENTAL

Iberis Multielectrode Renal Denervation System (AngioCare)

Device: Renal Denervation System (AngioCare)

Sham procedure

SHAM COMPARATOR

Renal anigography

Procedure: Sham procedure

Interventions

Renal Denervation System (AngioCare)DEVICE

After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

renal denervation
Sham procedurePROCEDURE

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.

Sham procedure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jiang X, Mahfoud F, Li W, Dong H, Yu J, Yu S, Chen X, Wang P, Li Z, Lauder L, Wang Z, Ji Z, Dong Y, Han B, Zhu Z, Chen Y, Xu J, Zhao X, Fan W, Xie W, Hubbard B, Hu X, Kario K, Gao R. Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial. Circulation. 2024 Nov 12;150(20):1588-1598. doi: 10.1161/CIRCULATIONAHA.124.069215. Epub 2024 Sep 4.

    PMID: 39229700DERIVED

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

September 15, 2016

Record last verified: 2016-09