Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 12, 2016
First Posted Date  ICMJE September 15, 2016
Last Update Posted Date September 15, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
  • Reduction in average 24-hour ambulatory systolic blood pressue at 6 months [ Time Frame: 6 months ]
  • Change in office systolic blood pressure [ Time Frame: 1 month,3 months,6 months and 12 months ]
  • Device or procedure related acute adverse events [ Time Frame: 1 month,3 months,6 months and 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Denervation by Iberis MultiElectrode Renal Denervation System in Patients With Primary Hypertension
Official Title  ICMJE A Prospective, Multi-centers, Randomized,Controlled, Blinded,Superiority Trial of Renal Denervation Using Iberis MultiElectrode Renal Denervation System for the Treatment of Primary Hypertension.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Primary Hypertension
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: renal denervation
    Iberis Multielectrode Renal Denervation System (AngioCare)
    Intervention: Device: Renal Denervation System (AngioCare)
  • Sham Comparator: Sham procedure
    Renal anigography
    Intervention: Procedure: Sham procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 14, 2016)
216
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02901704
Other Study ID Numbers  ICMJE AT201601
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shanghai AngioCare Medical
Study Sponsor  ICMJE Shanghai AngioCare Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai AngioCare Medical
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP