LEPU Renal Denervation System for Resistant Hypertension

NCT ID: NCT02536326

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-05-31

Brief Summary

The purpose was to evaluate 6-month outcomes of renal denervation(RDN) for the treatment of resistant hypertension in Chinese patients in a prospective cohort study.

Detailed Description

Currently, considerable data on RDN have been obtained from Western populations, while the clinical outcomes of RDN in East Asian populations are seldom reported. Therefore, the purpose was to evaluate 6-month outcomes of RDN for the treatment of resistant hypertension in Chinese patients.In a prospective single-center cohort study, 50 Chinese patients with resistant hypertension would be recruited to undergo RDN by LEPU Renal denervation system, which was similar to Symplicity the Symplicity renal-denervation system (Medtronic). The primary effectiveness endpoint was change in systolic and diastolic blood pressure at six months as measured by office-based blood pressure assessment and 24-hour ambulatory blood pressure monitoring following therapeutic renal denervation compared to baseline. The primary safety endpoint was the incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%) that required stenting or surgery, cerebrovascular accident, myocardial infarction, death.

Conditions

Hypertension; Cardiovascular Diseases; Vascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

renal denervation

Group Type: EXPERIMENTAL

LEPU Renal Denervation System

Intervention Type: DEVICE

LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)

Interventions

LEPU Renal Denervation System

LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18-65 years
• Stable medication regimen including ≥3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to RDN)
• 1) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour mean 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

• 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
• Widespread atherosclerosis with documented intravascular thrombosis or unstable 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

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: collaborator

Lepu Medical Technology (Beijing) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiongjing Jiang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Other Identifiers

2012-ZX-028

Identifier Type: -

Identifier Source: org_study_id