LEPU Renal Denervation System for Resistant Hypertension

Phase 3

Completed

• Conditions: Cardiovascular Diseases; Hypertension; Vascular Diseases
• Interventions: Device: LEPU Renal Denervation System

• Registration Number: NCT02536326
• Lead Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-08
• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-08-27
• Study First Posted: 2015-08-31
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
renal denervation	LEPU Renal Denervation System	-

Primary Outcome Measures

Name	Time	Method
2.Safety: The incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%)	through 6 months
Efficacy: Reduction of systolic blood pressure(SBP) and diastolic blood pressure(DBP) at six months as measured by office-based blood pressure assessment and ambulatory blood pressure monitoring(ABPM) compared to baseline	6 months after RDN

Secondary Outcome Measures

Name	Time	Method
Reduction in 24-h ambulatory blood pressure(ABPM) parameters	1 month,3 months,6 months after RDN
Symptomatic orthostatic hypotension, hypertensive emergency necessitating hospital admission	1 month,3 months,6 months after RDN
Device or procedure related acute adverse events（Renal artery edema、mural thrombus，change in transcatheter blood pressure >20%,<20% compared to baseline、reduction of heart rate >20%）	Perioperative period
Change in office SBP and DBP at 1, 3 months	1 month, 3 months after RDN
Change in average 24-hour SBP and DBP by ambulatory blood pressure monitoring (ABPM) at 1, 3 months	1 month, 3 months after RDN
Change in renal function at 6 months: Estimated glomerular filtration rate (eGFR) reduction >25%, 50%	6 months after RDN