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Clinical Trials/NCT02672462
NCT02672462
Unknown
Not Applicable

The Safety and Efficacy of a Renal Denervation System in Treating Patients With Hypertension: A Pilot Study

Shanghai Golden Leaf MedTec Co. Ltd1 site in 1 country20 target enrollmentDecember 2015
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ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Shanghai Golden Leaf MedTec Co. Ltd
Enrollment
20
Locations
1
Primary Endpoint
blood pressure
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

A single center, self-controlled pilot study on safety and efficacy of renal denervation in treatment of hypertension.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
June 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Shanghai Golden Leaf MedTec Co. Ltd
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Ages of 18 to 75, male or female;
  • •Main renal artery, with or without accessary renal arteries, with length
  • •Patients who have not taken any anti-hypertensive drugs or have been off drugs for at least 2 weeks, with mean SBP ≥150mmHg and
  • •180mmHg based on at least 3 office blood pressure measurements, or ASBP≥135mmHg and ≤170mmHg based on 24 hr blood pressure monitoring;
  • •Agrees to take part in the trial and signs the written, informed consent.

Exclusion Criteria

  • •Renal artery abnormalities that are inappropriate for the procedure;
  • •Pregnant or plan to become pregnant;
  • •History of orthostatic hypotension;
  • •Type I diabetes;
  • •Estimated GFR\<40mL/min/1.73m2;
  • •Only one kidney or prior kidney transplantation;
  • •Bleeding tendency or other coagulation related diseases;
  • •Acute or severe systemic infection;
  • •Prior renal artery interventional procedures or prior RDN treatment;
  • •History of stroke or TIA;

Outcomes

Primary Outcomes

blood pressure

Time Frame: 6 months

Study Sites (1)

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