Renal Artery StenosisNCT03252639
A Study of Using Parenchymal Blood Volume(PBV) for Endovascular Treatment of Renal Arterial Stenosis
An observational study of Renal Artery Stenosis and Renal Blood Perfusion, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Artery Stenosis, Renal Blood Perfusion
- What is being tested?
- EVT for RAS & PBV acquisition protocol for target kidneys
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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%).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Bao Liu, MD, +86-10-69152502, liubao72@aliyun.com
About this study
Official title: 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.
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.
- Conditions
- Renal Artery Stenosis, Renal Blood Perfusion
- Being tested
- EVT for RAS & PBV acquisition protocol for target kidneys
- Keywords
- Renal Artery Stenosis, Renal Blood Perfusion
- Medical subject headings
- Renal Artery Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVT for RAS & PBV acquisition protocol for target kidneysProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: EVT for RAS & PBV acquisition protocol for target kidneys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney Volume
the volume of kidney, which is able to indicate total blood volume of kidney, in target kidney
Measured: 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
Measured: 15 minutes before endovascular treatment, changes at 15 minutes after endovascular treatment, 6-month and 12-month follow-up respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study startNov 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Artery StenosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bao Liu, MD, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252639
- Sponsor's protocol ID
- PUMCH-2016-1.20
- Status last verified
- Aug 2017
- First submitted
- 10 Aug 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Using Parenchymal Blood Volume(PBV) for Endovascular Treatment of Renal Arterial Stenosis
- ClinicalTrials.gov ID
- NCT03252639
- Acronym / sponsor ID
- PUMCH-2016-1.20
- Conditions
- Renal Artery Stenosis, Renal Blood Perfusion
- Keywords
- Renal Artery Stenosis, Renal Blood Perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Renal Artery Stenosis | – | Procedure: EVT for RAS & PBV acquisition protocol for target kidneysPatients with renal artery stenosis which may benefit from endovascular treatment will be recruited. Those patients who cannot benefit from this procedure will be excluded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVT for RAS & PBV acquisition protocol for target kidneys | Procedure or surgery | Patients with Renal Artery Stenosis |
Primary outcome
Kidney Volume
Time frame: 15 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 contrast
Time frame: 15 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bao Liu, MD study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Artery Stenosis and Renal Blood Perfusion, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bao Liu, MD (+86-10-69152502, liubao72@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney Volume (time frame: 15 minutes before endovascular treatment, changes at 15 minutes after endovascular treatment, 6-month and 12-month follow-up respectively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.