NCT02536326

LEPU Renal Denervation System for Resistant Hypertension

LEPU Renal Denervation System for Resistant Hypertension in Chinese Populations

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	LEPU Renal Denervation System	LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-08-31
• Last updated: 2015-09-02