NCT01848275

Full Length Versus Proximal Renal Arteries Ablation

The Clinical Efficacy Comparison of Two Renal Sympathetic Denervation Strategies ---- Full Length Versus Proximal Renal Arteries Ablation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Catheter-based renal sympathetic modification has been documented to be effective option for blood pressure control in patients with resistant hypertension, but the safety is still concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at proximity may be enough for successful renal sympathetic modifications. This study was designed to compare the efficacy and safety of full length versus proximal ablation of bilateral renal arteries.

Detailed description

After baseline assessment was completed, patients with resistant hypertension were enrolled, and randomly divided into two groups. This study is going to recruit 40 patients (group 1 VS group 2 = 1:1) with a follow-up duration of one year. Group 1 received ablation from distal to ostial of bilateral renal arteries, group 2 received ablation at proximal of bilateral renal arteries. RDN was performed with saline irrigated catheter. Office and ambulatory blood pressure was measured.

Conditions

• Hypertension, Resistant to Conventional Therapy

Interventions

Type	Name	Description
DEVICE	Thermocool®Rcatheter	The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter
DEVICE	Thermocool®Rcatheter	The proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2013-05-07
• Last updated: 2017-07-17

Locations

1 site across 1 country: China