Status:
TERMINATED
Renal Denervation by Allegro System in Patients With Resistant Hypertension
Lead Sponsor:
Shanghai AngioCare Medical
Conditions:
Renal Denervation
Resistant Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with resistant hypertension by using Allegro renal denervation system
Eligibility Criteria
Inclusion
- Age 18 - 65 years at time of randomization
- Stable medication regimen including 3 or more antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and no expected changes for at least 6 months
- 1\) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour average SBP and/or DBP ≥140 and/or 90 mmHg
- Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation)
- eGFR≥45 mL/min/1.73 m2
- Written informed consent
Exclusion
- Type 1 diabetes mellitus
- Secondary hypertension
- 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
- Intravascular thrombosis or unstable atherosclerotic plaques
- 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
- Angiographic
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01874470
Start Date
May 1 2013
End Date
May 1 2014
Last Update
October 20 2016
Active Locations (1)
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1
Fuwai hospital
Beijing, China