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

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ClinicalTrials.gov Identifier: NCT02901704
Recruitment Status : Unknown
Verified September 2016 by Shanghai AngioCare Medical.
Recruitment status was:  Not yet recruiting
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai AngioCare Medical

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

Condition or disease Intervention/treatment Phase
Primary Hypertension Device: Renal Denervation System (AngioCare) Procedure: Sham procedure Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : December 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: renal denervation
Iberis Multielectrode Renal Denervation System (AngioCare)
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.

Sham Comparator: Sham procedure
Renal anigography
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.




Primary Outcome Measures :
  1. Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Reduction in average 24-hour ambulatory systolic blood pressue at 6 months [ Time Frame: 6 months ]
  2. Change in office systolic blood pressure [ Time Frame: 1 month,3 months,6 months and 12 months ]
  3. Device or procedure related acute adverse events [ Time Frame: 1 month,3 months,6 months and 12 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Shanghai AngioCare Medical
ClinicalTrials.gov Identifier: NCT02901704     History of Changes
Other Study ID Numbers: AT201601
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases