ClinicalTrials.gg
Status unknownNCT03252639Updated Aug 17, 2017

A Study of Using Parenchymal Blood Volume(PBV) for Endovascular Treatment of Renal Arterial Stenosis

An observational study in Renal Artery Stenosis and Renal Blood Perfusion, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-17.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Renal Artery Obstruction with a site in China — 5 open to participants now, 5 under way, none of them phase 3. Renal Artery Obstruction · China.

Started
2016
the only one that year
Observational
3 of 13
none open now
Registered
3rd of 13
by date
Lead sponsor
3 of 13
Peking Union Medical College Hospital

Among the 13 studies in Renal Artery Obstruction with a site in China, this one is the only one that started in 2016, is one of 3 observational ones, and was the 3rd registered.

Renal Artery Obstruction

59 studies on the registry are indexed under Renal Artery Obstruction; 10 are open to participants now.

Browse Renal Artery Obstruction studies →

Open to participants now

5 of the 13 studies in Renal Artery Obstruction with a site in China are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 7 Renal Artery Obstruction studies recruiting now, 6 set no upper age limit and none stop at 75 or younger; 1 takes children under 18; none take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Renal Artery Obstruction with a site in China, or all of them as a file.
02

Study 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.

Read the detailed description

BACKGROUND: Renal artery stenosis (RAS) is one of the main reasons for secondary hypertension and renal failure, which etiologies include atherosclerosis, fibromuscular dysplasia and takayasu arteritis. Endovascular treatment under digital subtraction angiography (DSA) is an option to treat this disease. However, the technical success of this procedure is mainly based on morphology of its targeting renal artery without any quantified data towards renal blood perfusion. Thus, this study will try to solve how renal blood perfusion changes before and after endovascular treatment of renal artery stenosis.

DESIGN NARRATIVE:

This prospective cohort study will recruit patients with renal artery stenosis. PBV data will be obtained before and after their endovascular treatments. The volume of target kidney and its mean density of contrast from PBV data will be calculated as indicators for renal perfusion. And the relation between the percentage of stenosis and renal perfusion will be analyzed. The follow-up will last for one year. At 6-month and 12-month follow-up, DSA and PBV acquisition protocol will be undertaken again to evaluate renal blood perfusion in the long term.

03

Conditions studied

  • Renal Artery Stenosis
  • Renal Blood Perfusion

Keywords

  • Renal Artery Stenosis
  • Renal Blood Perfusion
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients should meet all of the following criteria:

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

Exclusion criteria

Exclusion Criteria:

Patients meet any of the following criteria should be excluded.

  1. Unable or willing to comply with study protocol or procedures.
  2. Pregnancy or lactation.
  3. History of kidney transplant.
  4. Currently in acute pulmonary edema OR systolic of heart \<30% OR respiratory failure due to hypertension or acute coronary syndrome or cerebrovascular accident in past 3 months.
  5. The 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.
  6. Other known reason nonischemic kidney injure(e.g. nephritis). If it is diabetic nephropathy, 24h urinary protein should be more then 3g.
  7. Aorta has stenosis(greater than 30%).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureEVT for RAS & PBV acquisition protocol for target kidneys
06

What researchers measure

Primary outcomes

  1. Kidney Volume

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

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

  2. mean density of contrast

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

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

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2016 (actual). Primary completion is estimated for Jul 2018, 20 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2017
First posted
Aug 17, 2017
StartActual
Nov 2016
Primary completionEst.
Jul 2018
CompletionEst.
Jul 2018
Last update
Aug 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03252639
Responsible party
Sponsor
First posted
Aug 17, 2017
Start date
Nov 2016
Primary completion
Jul 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
Aug 17, 2017

Study contacts

Bao Liu, MD
Contact
liubao72@aliyun.com
+86-10-69152502
Bao Liu, MD
study director · Peking Union Medical College Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion