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

Primary Hypertension Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02901704
• Other study ID #: AT201601
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 12, 2016
• Last updated: September 14, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2016
• Source: Shanghai AngioCare Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Primary Hypertension

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai AngioCare Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up		3 months	No
Secondary	Reduction in average 24-hour ambulatory systolic blood pressue at 6 months		6 months	No
Secondary	Change in office systolic blood pressure		1 month,3 months,6 months and 12 months	No
Secondary	Device or procedure related acute adverse events		1 month,3 months,6 months and 12 months	Yes