LEPU Renal Denervation System for Resistant Hypertension (LEPU-RDN)

Lepu Medical Technology

Status and phase: Completed; Phase 3

Conditions: Hypertension; Cardiovascular Diseases; Vascular Diseases

Treatments: Device: LEPU Renal Denervation System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02536326

2012-ZX-028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

1. Clinical 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

2. Anatomic 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

renal denervation

Experimental group

Treatment:

Device: LEPU Renal Denervation System