A Study of Using Parenchymal Blood Volume(PBV) for Endovascular Treatment of Renal Arterial Stenosis
NCT ID: NCT03252639
Last Updated: 2017-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
60 participants
OBSERVATIONAL
2016-11-30
2018-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis
NCT04366596
Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis--a Multicenter Study
NCT05858190
Endovascular Therapy for Renal Artery Stenosis in China
NCT03080519
Fractional Flow Reserve-guided Stenting Versus Medical Therapy in Atherosclerosis Renal Artery Stenosis
NCT06447740
Revascularization of Renal Artery Stenosis Versus Medical Therapy for the Treatment of Ischemic Nephropathy
NCT01023373
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
EVT for RAS & PBV acquisition protocol for target kidneys
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EVT for RAS & PBV acquisition protocol for target kidneys
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
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%).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking Union Medical College Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bao Liu, MD
Role: STUDY_DIRECTOR
Peking Union Medical College Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PUMCH-2016-1.20
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.