NCT03252639

Brief Summary

This study will use PBV technique to quantitatively assess the improvement of renal perfusion before and after endovascular treatment (EVT) of renal artery stenosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

August 10, 2017

Last Update Submit

August 14, 2017

Conditions

Renal Artery StenosisRenal Blood Perfusion

Keywords

Renal Artery StenosisRenal Blood Perfusion

Outcome Measures

Primary Outcomes (2)

  • Kidney Volume

    the volume of kidney, which is able to indicate total blood volume of kidney, in target kidney

    15 minutes before endovascular treatment, changes at 15 minutes after endovascular treatment, 6-month and 12-month follow-up respectively.

  • mean density of contrast

    the mean density of contrast, which is able to represent renal blood perfusion, in target kidney

    15 minutes before endovascular treatment, changes at 15 minutes after endovascular treatment, 6-month and 12-month follow-up respectively.

Study Arms (1)

Patients with Renal Artery Stenosis

Patients with renal artery stenosis which may benefit from endovascular treatment will be recruited. Those patients who cannot benefit from this procedure will be excluded.

Procedure: EVT for RAS & PBV acquisition protocol for target kidneys

Interventions

EVT for RAS & PBV acquisition protocol for target kidneysPROCEDURE
Patients with Renal Artery Stenosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients who meet the inclusion criteria, are willing to join this trial and treated in the department of vascular surgery, Peking Union Medical College Hospital will be included in this prospective cohort study.

You may qualify if:

  • Patients should meet all of the following criteria:
  • Age ≥ 18.
  • Renal artery stenosis is greater than or equal to 80% and less than 100% by duplex, CT angiography or magnetic resonance angiography.
  • The target kidney remains functional(tested by radionuclide imaging)
  • Documented history of hypertension on two or more anti-hypertensive medications OR estimated glomerular filtration rate (eGFR) less than 60 mL per minute per 1.73 m\^2, calculated by the modified Modification of Diet in Renal Disease formula.
  • The length of target kidney is \>8cm.

You may not qualify if:

  • Patients meet any of the following criteria should be excluded.
  • Unable or willing to comply with study protocol or procedures.
  • Pregnancy or lactation.
  • History of kidney transplant.
  • Currently in acute pulmonary edema OR systolic ejection fraction of heart \<30% OR respiratory failure due to hypertension or acute coronary syndrome or cerebrovascular accident in past 3 months.
  • The eGFR is less than 15 mL per minute per 1.73 m\^2 OR serum Cr is greater than 3.0 mg/dl on the day of randomization.
  • Other known reason nonischemic kidney injure(e.g. nephritis). If it is diabetic nephropathy, 24h urinary protein should be more then 3g.
  • Aorta has stenosis(greater than 30%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Renal Artery Obstruction

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bao Liu, MD

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Bao Liu, MD

CONTACT

+86-10-69152502liubao72@aliyun.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 17, 2017

Study Start

November 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 17, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)