Renal Denervation by Allegro System in Patients With Resistant Hypertension

NCT ID: NCT01874470

Last Updated: 2016-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-05-31

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

Conditions

Renal Denervation; Resistant Hypertension; Standard Medication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard medication

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

Group Type: PLACEBO_COMPARATOR

standard medication

Intervention Type: OTHER

renal denervation

Allegro Renal Denervation System (AngioCare)

Group Type: EXPERIMENTAL

renal denervation

Intervention Type: DEVICE

standard medication

Intervention Type: OTHER

Interventions

renal denervation

Intervention Type: DEVICE

standard medication

Intervention Type: OTHER

Other Intervention Names

Allegro Renal Denervation System (AngioCare); Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai AngioCare Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuwai hospital

Beijing, , China

Countries

China

Other Identifiers

Allegro-HTN

Identifier Type: -

Identifier Source: org_study_id