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

NCT02901704 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2016-09-15

No results posted yet for this 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

Conditions

  • Primary Hypertension

Interventions

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.

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.

Sponsors & Collaborators

  • Shanghai AngioCare Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-06-30
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02901704 on ClinicalTrials.gov