NCT02672462

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

February 1, 2016

Last Update Submit

February 2, 2016

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    6 months

Study Arms (1)

Renal denervation

EXPERIMENTAL
Device: Radio frequency renal denervation system (Golden Leaf GL-06E15A)

Interventions

Radio frequency renal denervation system (Golden Leaf GL-06E15A)DEVICE
Renal denervation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages of 18 to 75, male or female;
  • Main renal artery, with or without accessary renal arteries, with length
  • mm;
  • Patients who have not taken any anti-hypertensive drugs or have been off drugs for at least 2 weeks, with mean SBP ≥150mmHg and
  • mmHg 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.

You may not qualify if:

  • 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;
  • Malignant tumor or end-stage illnesses;
  • Secondary hypertension;
  • Acute coronary events within 2 weeks;
  • Other conditions that deem unsuitable for the procedure, in the opinions of investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Gengshan Ma, MD

    Cardiovascular division, Dept. of Internal Medicine, Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gengshan Ma, MD

CONTACT

(86)13002580569

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 3, 2016

Study Start

December 1, 2015

Primary Completion

June 1, 2016

Last Updated

February 4, 2016

Record last verified: 2016-02

Locations

CN(1)