Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Full Length Versus Proximal Renal Arteries Ablation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Second Affiliated Hospital of Chongqing Medical University
Sponsor:
Information provided by (Responsible Party):
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01848275
First received: May 3, 2013
Last updated: May 6, 2013
Last verified: May 2013

May 3, 2013
May 6, 2013
March 2011
August 2013   (final data collection date for primary outcome measure)
Blood pressure [ Time Frame: One year ] [ Designated as safety issue: Yes ]
office BP and Ambulatory blood pressure
Same as current
Complete list of historical versions of study NCT01848275 on ClinicalTrials.gov Archive Site
ablation-related complications [ Time Frame: One year ] [ Designated as safety issue: Yes ]
ablation-related complications such as pseudoaneurysm,renal artery injury
Same as current
Not Provided
Not Provided
 
Full Length Versus Proximal Renal Arteries Ablation
The Clinical Efficacy Comparison of Two Renal Sympathetic Denervation Strategies ---- Full Length Versus Proximal Renal Arteries Ablation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension, Resistant to Conventional Therapy
  • 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
  • Active Comparator: Group 1
    Group 1 received ablation from distal to ostial of bilateral renal arteries
    Intervention: Device: Thermocool®Rcatheter
  • Experimental: Group 2
    group 2 received ablation at proximal of bilateral renal arteries
    Intervention: Device: Thermocool®Rcatheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • office systolic blood pressure of 160 mm Hg or more,
  • patients had to be on a stable drug regimen of at least 3 antihypertensive medications with no changes for 1 month before enrollment.
  • Despite being treated with at least three antihypertensive drugs(including one diuretic), or confirmed intolerance to medications;
  • ≥ 18 years old,;
  • did not have any known secondary cause of hypertension;
  • had a glomerular filtration rate estimated with the modification of diet in renal disease formula, of 45 ml/min/1.73m2 or more.

Exclusion Criteria:

  • patients with type 1 diabetes,
  • implanted pacemakers or implantable cardioverter defibrillators;
  • pregnant women;
  • haemodynamically significant valvular disease;
  • patients with renovascular abnormalities(including mild to severe renal artery stenosis, especially caused by atherosclerosis, previous renal stenting or angioplasty, or known dual renal arteries, or diameter of renal artery identified by angiography less than 4 mm and/or length of renal artery less than 2 cm)
Both
18 Years to 75 Years
No
Contact: Yuehui Yin, MD 0086-13508335502 yinyh63@163.com
China
 
NCT01848275
SWAN- RDN Strategy
Yes
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Chongqing Medical University
Not Provided
Not Provided
The Second Affiliated Hospital of Chongqing Medical University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP