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

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

Study Overview

• Status: Unknown
• Conditions: Renal Artery Stenosis; Renal Blood Perfusion
• Intervention / Treatment: Procedure: EVT for RAS & PBV acquisition protocol for target kidneys

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Bao Liu, MD; Phone Number: +86-10-69152502; Email: liubao72@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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%).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Bao Liu, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Renal Artery Stenosis; Renal Blood Perfusion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Constriction, Pathologic; Renal Artery Obstruction
• Other Study ID Numbers: PUMCH-2016-1.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No