Renal Denervation by Allegro System in Patients With Resistant Hypertension

Shanghai AngioCare Medical

Status and phase: Terminated; Phase 3

Conditions: Standard Medication; Resistant Hypertension; Renal Denervation

Treatments: Other: standard medication; Device: renal denervation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01874470

Allegro-HTN

Details and patient eligibility

About

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

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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 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 <4 mm diameter or with <20 mm treatable length (by visual estimation)
• Renal artery abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups, including a placebo group

standard medication

Placebo Comparator group

Description:

Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic

Treatment:

Other: standard medication

renal denervation

Experimental group

Description:

Allegro Renal Denervation System (AngioCare)

Treatment:

Device: renal denervation

Other: standard medication