Iberis-HTN: Renal Denervation by Iberis MultiElectrode Renal Denervation System in Patients With Primary Hypertension
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up [3 months]
Secondary Outcome Measures
- Reduction in average 24-hour ambulatory systolic blood pressue at 6 months [6 months]
- Change in office systolic blood pressure [1 month,3 months,6 months and 12 months]
- Device or procedure related acute adverse events [1 month,3 months,6 months and 12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 - 65 years
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Primary Hypertension
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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
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Main renal arteries with ≥3 mm diameter or with ≥20 mm treatable length (by visual estimation)
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Written informed consent
Exclusion Criteria:
Clinical Exclusion Criteria:
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Known secondary hypertension
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Type 1 diabetes mellitus
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Has an implantable cardioverter defibrillator (ICD) or pacemaker
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Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
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Has hemodynamically significant valvular heart disease
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Pregnant, nursing, or planning to be pregnant
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Any serious medical condition that may adversely affect the safety of the participant or the study
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Currently enrolled in another investigational drug or device trial
2.Angiographic Exclusion Criteria
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Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
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History of prior renal artery intervention including balloon angioplasty or stenting
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Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney
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Main renal arteries with <3 mm diameter or with <20 mm treatable length (by visual estimation)
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Renal artery abnormalities
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai AngioCare Medical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AT201601