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

Primary Purpose

Primary Hypertension

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Renal Denervation System (AngioCare)

Sham procedure

About this trial

This is an interventional treatment trial for Primary Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

renal denervation

Sham procedure

Arm Description

Iberis Multielectrode Renal Denervation System (AngioCare)

Renal anigography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduction in average 24-hour ambulatory systolic blood pressue at 6 months

Change in office systolic blood pressure

Device or procedure related acute adverse events

Full Information

NCT ID

NCT02901704

First Posted

September 12, 2016

Last Updated

September 14, 2016

Sponsor

Shanghai AngioCare Medical

1. Study Identification

Unique Protocol Identification Number

NCT02901704

Brief Title

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

Acronym

Iberis-HTN

Official Title

A Prospective, Multi-centers, Randomized,Controlled, Blinded,Superiority Trial of Renal Denervation Using Iberis MultiElectrode Renal Denervation System for the Treatment of Primary Hypertension.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai AngioCare Medical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

renal denervation

Arm Type

Experimental

Arm Description

Iberis Multielectrode Renal Denervation System (AngioCare)

Arm Title

Sham procedure

Arm Type

Sham Comparator

Arm Description

Renal anigography

Intervention Type

Device

Intervention Name(s)

Renal Denervation System (AngioCare)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Sham procedure

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Reduction in average 24-hour ambulatory systolic blood pressue at 6 months

Time Frame

6 months

Title

Change in office systolic blood pressure

Time Frame

1 month,3 months,6 months and 12 months

Title

Device or procedure related acute adverse events

Time Frame

1 month,3 months,6 months and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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