Renal Artery StenosisNCT05603221
Renal Perfusion Assessment in the Endovascular Treatment of Renal Artery Stenosis
An observational study of Renal Artery Stenosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The clinical benefits of endovascular treatment in renal artery stenosis remain controversial. This study uses arterial spin labelling MRI and flat-panel detector parenchymal blood volume imaging to observe the change in renal perfusion after endovascular treatment in renal artery stenosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Artery Stenosis
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2020to 30 Jun 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was conducted in renal artery stenosis patients aged 18 to 80 years with uncontrolled blood pressure or impaired renal function, who were intended for endovascular treatment. CTA, MRA, or Doppler ultrasonography were used for the assessment of the stenosis percentage of renal artery. Subjects with technical failure were excluded in order to reduce the influence of other variables.
Who may be able to join
- patients who provided informed consent
- patients who were diagnosed with RAS by CTA, MRA, or Doppler ultrasonography
- patients who were aged 18 years or older
- patients whose intervened renal arteries were not completely occluded (confirmed by DSA)
- the stenosis percentage exceeding 70%
- patients who had uncontrolled blood pressure or impaired renal function
- paitents whose affected kidney did not have total loss of function
Who cannot join
- were pregnant
- had a history of renal transplantation or renal artery bypass surgery
- were allergic to iodine contrast medium
- had other contraindications of endovascular treatment
- contraindications of MRI examinations
- had technical failure in the endovascular treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Bao Liu, MD, 010-69152592, liubao72@aliyun.com
About this study
Official title: Perfusion Assessment Using Arterial Spin Labelling MRI and Flat-panel Detector Parenchymal Blood Volume Imaging in Endovascular Treatment of Renal Artery Stenosis
The clinical benefits of endovascular treatment in renal artery stenosis remain controversial. This study uses arterial spin labelling MRI and flat-panel detector parenchymal blood volume imaging to observe the change in renal perfusion after endovascular treatment in renal artery stenosis.
- Conditions
- Renal Artery Stenosis
- Keywords
- renal artery stenosis, renal 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.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Group | Patients who had successful endovascular revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion of the target kidney assessed by Arterial Spin Labelling MRI
Measured: Changes from baseline renal perfusion at 2 months
Perfusion of the target kidney assessed by Flat-panel Detector Parenchymal Blood Volume Imaging
Measured: Changes from baseline renal perfusion immediately after endovascular intervention
Secondary outcomes (2)
Blood pressure
Measured: Changes from baseline blood pressure at 1 year
Renal function
Measured: Changes from baseline renal function at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start4 Nov 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603221
- Sponsor's protocol ID
- ASL and PBV in RAS
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Assessment Using Arterial Spin Labelling MRI and Flat-panel Detector Parenchymal Blood Volume Imaging in Endovascular Treatment of Renal Artery Stenosis
- ClinicalTrials.gov ID
- NCT05603221
- Acronym / sponsor ID
- ASL and PBV in RAS
- Conditions
- Renal Artery Stenosis
- Keywords
- renal artery stenosis, renal perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 2 Nov 2022 (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.
The clinical benefits of endovascular treatment in renal artery stenosis remain controversial. This study uses arterial spin labelling MRI and flat-panel detector parenchymal blood volume imaging to observe the change in renal perfusion after endovascular treatment in renal artery stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular Group | – | –Patients who had successful endovascular revascularization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted in renal artery stenosis patients aged 18 to 80 years with uncontrolled blood pressure or impaired renal function, who were intended for endovascular treatment. CTA, MRA, or Doppler ultrasonography were used for the assessment of the stenosis percentage of renal artery. Subjects with technical failure were excluded in order to reduce the influence of other variables.
Key inclusion criteria (7 listed)
- patients who provided informed consent
- patients who were diagnosed with RAS by CTA, MRA, or Doppler ultrasonography
- patients who were aged 18 years or older
- patients whose intervened renal arteries were not completely occluded (confirmed by DSA)
- the stenosis percentage exceeding 70%
Key exclusion criteria (6 listed)
- were pregnant
- had a history of renal transplantation or renal artery bypass surgery
- were allergic to iodine contrast medium
- had other contraindications of endovascular treatment
- contraindications of MRI examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perfusion of the target kidney assessed by Arterial Spin Labelling MRI
Time frame: Changes from baseline renal perfusion at 2 months
Perfusion of the target kidney assessed by Flat-panel Detector Parenchymal Blood Volume Imaging
Time frame: Changes from baseline renal perfusion immediately after endovascular intervention
2 secondary outcomes
Blood pressure
Time frame: Changes from baseline blood pressure at 1 year
Renal function
Time frame: Changes from baseline renal function at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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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.
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, 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 7 inclusion and 6 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 2 Nov 2022. 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 (010-69152592, liubao72@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion of the target kidney assessed by Arterial Spin Labelling MRI (time frame: Changes from baseline renal perfusion at 2 months). 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 2 Nov 2022.