Clinical trial NCT02901704: Renal Denervation by Iberis MultiElectrode Renal Denervation System in Patients With Primary Hypertension
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Hypertension
Lead sponsor: Shanghai AngioCare Medical
Sponsor class: INDUSTRY
First posted: 2016-09-15
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up
timeFrame: 3 months
Secondary outcomes:
measure: Reduction in average 24-hour ambulatory systolic blood pressue at 6 months
timeFrame: 6 months
measure: Change in office systolic blood pressure
timeFrame: 1 month,3 months,6 months and 12 months
measure: Device or procedure related acute adverse events
timeFrame: 1 month,3 months,6 months and 12 months
Other outcomes:
Locations:
Study officials:
References: