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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03252639
Enrollment
60
Registered
2017-08-17
Start date
2016-11-30
Completion date
2018-07-31
Last updated
2017-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Artery Stenosis, Renal Blood Perfusion

Keywords

Renal Artery Stenosis, Renal Blood Perfusion

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.

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.

Interventions

PROCEDUREEVT for RAS & PBV acquisition protocol for target kidneys

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 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. 5. The length of target kidney is \>8cm.

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 ejection fraction of heart \<30% OR respiratory failure due to hypertension or acute coronary syndrome or cerebrovascular accident in past 3 months. 5. 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. 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%).

Design outcomes

Primary

MeasureTime frameDescription
Kidney Volume15 minutes before endovascular treatment, changes at 15 minutes after endovascular treatment, 6-month and 12-month follow-up respectively.the volume of kidney, which is able to indicate total blood volume of kidney, in target kidney
mean density of contrast15 minutes before endovascular treatment, changes at 15 minutes after endovascular treatment, 6-month and 12-month follow-up respectively.the mean density of contrast, which is able to represent renal blood perfusion, in target kidney

Countries

China

Contacts

Primary ContactBao Liu, MD
liubao72@aliyun.com+86-10-69152502

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026