Renal Artery StenosisNCT03530748
On-table Renal Perfusion Evaluation Renal Artery Stenosis or Obstruction
An observational study of Renal Artery Stenosis and Aortic Dissection, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
1. Evaluate the feasibility for the on-table evaluation of the renal perfusion by using Syngo Dyna Parenchymal Blood Volume(PBV) Body; 2. Explore the clinical benefits of this application during procedure to help the physician to determine the procedure endpoint. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Artery Stenosis, Aortic Dissection, Renal Perfusion
- What is being tested?
- Endovascular therapy and Imaging Acquisition
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2018to 31 Dec 2020
- 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: Consecutive patients who meet the inclusion criteria, are willing to comply with this protocol, and receive endovasculara therapy in the Department of Vascular Surgery, Zhongshan Hospital will be included.
Who may be able to join
- Renal artery stenosis ≥ 60% and < 100% by doppler ultrasonography, CT angiography or magnetic resonance angiography;
- Target kidney remains functional (GFR determined);
- The length of target kidney is >8cm;
- Resistance index tested by doppler ultrasonography <0.8;
- Comply with the protocol
Who cannot join
- Severe cardiopulmonary insufficiency, hepatic dysfunction, renal inadequacy and clotting mechanism abnormality;
- Pregnancy or lactation;
- History of renal artery surgery;
- Allergy of contrast agent;
- Other known reason nonischemic kidney disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Zhenyu Shi, PhD
About this study
Official title: On-table Renal Perfusion Evaluation for Patients With Renal Artery Stenosis or Aortic Dissection With Renal Artery Obstruction
- Evaluate the feasibility for the on-table evaluation of the renal perfusion by using Syngo Dyna Parenchymal Blood Volume(PBV) Body;
- Explore the clinical benefits of this application during procedure to help the physician to determine the procedure endpoint.
Read the detailed description
Renal artery stenosis (RAS) is one of the potential manifestations of peripheral artery diseases and it is often observed in patients with evolving renal function impairment and concomitant coronary artery disease, or in those suffering from hypertension refractory to medical therapy.Percutaneous renal artery stenting is an effective therapeutic tool and represents the treatment of choice for RAS. Identification of parameters able to discriminate patients who benefit from RAS stenting, thus, has become of crucial importance if this technique has to survive.
Aortic dissection represents a common cardiovascular disease and it is responsible for the most commonly encountered pathologies in aortic emergency. Renal dysfunction is a common complication associated with aortic dissection, with resultant high mortality rate. The antegrade propagation of the dissection from the proximal aorta to the level of renal arteries and the intervention during surgery may both increase the risk of renal malperfusion; thus, it is important to assess renal function for pre- and post-operative evaluation and guidance for treatment. This can be achieved through perfusion imaging.
Presently, C-arm Cone Beam Computed Tomography (CBCT) perfusion is well established, in particular, in the diagnostic assessment of acute stroke and cerebral ischemia. The main novelty of our study lies in the fact that intra-procedural renal perfusion assessed for the first time semiquantitatively by Syngo Dyna Parenchymal Blood Volume(PBV) software, discriminate patients who will benefit from the intervention procedure.
In conclusion, our study suggests that a routine assessment of pre, and post-stenting renal perfusion could help to identify patients at higher risk of no improvement or even worsening of renal function after stenting and, perhaps, more aggressive medical therapy.
- Being tested
- Endovascular therapy and Imaging Acquisition
- Medical subject headings
- Renal Artery Obstruction, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular therapy and Imaging AcquisitionProcedure or surgery
- Endovascular repair for renal artery stenosis;
- Parenchymal Blood Volume(PBV) acquisition and analysis for target kidney
| Study group | Role | What they receive |
|---|---|---|
| Patients with Renal Artery Stenosis | Patients with simple renal artery stenosis or aortic dissection with renal artery obstruction Receives: Procedure: Endovascular therapy and Imaging Acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular Filtration Rate
The golden standard of renal function, tested by radionuclide imaging
Measured: Change from Baseline Glomerular Filtration Rate at 3 months
Secondary outcomes (2)
Kidney Volume
Total blood volume of kidney, tested by PBV
Measured: 10 minutes pre- and post-endovascular therapy on table
Mean Density of Contrast agent
Renal blood perfusion, tested by PBV
Measured: 10 minutes pre- and post-endovascular therapy on table
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start9 Apr 2018
- Primary completion9 Jun 2020 (estimated)
- Study completion31 Dec 2020 (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 Shanghai Zhongshan 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
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Shi, Shanghai Zhongshan Hospital
- Investigators
- Zhenyu Shi, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530748
- Sponsor's protocol ID
- B2017-084
- Status last verified
- May 2020
- First submitted
- 10 Apr 2018
- Last updated
- 13 May 2020
- Results posted
- 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 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-table Renal Perfusion Evaluation for Patients With Renal Artery Stenosis or Aortic Dissection With Renal Artery Obstruction
- ClinicalTrials.gov ID
- NCT03530748
- Acronym / sponsor ID
- B2017-084
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 9 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 21 May 2018 (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.
- Evaluate the feasibility for the on-table evaluation of the renal perfusion by using Syngo Dyna Parenchymal Blood Volume(PBV) Body;
- Explore the clinical benefits of this application during procedure to help the physician to determine the procedure endpoint.
Detailed description
Renal artery stenosis (RAS) is one of the potential manifestations of peripheral artery diseases and it is often observed in patients with evolving renal function impairment and concomitant coronary artery disease, or in those suffering from hypertension refractory to medical therapy.Percutaneous renal artery stenting is an effective therapeutic tool and represents the treatment of choice for RAS. Identification of parameters able to discriminate patients who benefit from RAS stenting, thus, has become of crucial importance if this technique has to survive.
Aortic dissection represents a common cardiovascular disease and it is responsible for the most commonly encountered pathologies in aortic emergency. Renal dysfunction is a common complication associated with aortic dissection, with resultant high mortality rate. The antegrade propagation of the dissection from the proximal aorta to the level of renal arteries and the intervention during surgery may both increase the risk of renal malperfusion; thus, it is important to assess renal function for pre- and post-operative evaluation and guidance for treatment. This can be achieved through perfusion imaging.
Presently, C-arm Cone Beam Computed Tomography (CBCT) perfusion is well established, in particular, in the diagnostic assessment of acute stroke and cerebral ischemia. The main novelty of our study lies in the fact that intra-procedural renal perfusion assessed for the first time semiquantitatively by Syngo Dyna Parenchymal Blood Volume(PBV) software, discriminate patients who will benefit from the intervention procedure.
In conclusion, our study suggests that a routine assessment of pre, and post-stenting renal perfusion could help to identify patients at higher risk of no improvement or even worsening of renal function after stenting and, perhaps, more aggressive medical therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Renal Artery Stenosis | – | Procedure: Endovascular therapy and Imaging AcquisitionPatients with simple renal artery stenosis or aortic dissection with renal artery obstruction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who meet the inclusion criteria, are willing to comply with this protocol, and receive endovasculara therapy in the Department of Vascular Surgery, Zhongshan Hospital will be included.
Key inclusion criteria (5 listed)
- Renal artery stenosis ≥ 60% and < 100% by doppler ultrasonography, CT angiography or magnetic resonance angiography;
- Target kidney remains functional (GFR determined);
- The length of target kidney is >8cm;
- Resistance index tested by doppler ultrasonography <0.8;
- Comply with the protocol
Key exclusion criteria (5 listed)
- Severe cardiopulmonary insufficiency, hepatic dysfunction, renal inadequacy and clotting mechanism abnormality;
- Pregnancy or lactation;
- History of renal artery surgery;
- Allergy of contrast agent;
- Other known reason nonischemic kidney disease
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 |
|---|---|---|
| Endovascular therapy and Imaging Acquisition1. Endovascular repair for renal artery stenosis; 2. Parenchymal Blood Volume(PBV) acquisition and analysis for target kidney | Procedure or surgery | Patients with Renal Artery Stenosis |
Primary outcome
Glomerular Filtration Rate
Time frame: Change from Baseline Glomerular Filtration Rate at 3 months
The golden standard of renal function, tested by radionuclide imaging
2 secondary outcomes
Kidney Volume
Time frame: 10 minutes pre- and post-endovascular therapy on table
Mean Density of Contrast agent
Time frame: 10 minutes pre- and post-endovascular therapy on table
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- 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.
Zhenyu Shi, PhD principal investigator
Fudan University
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 Aortic Dissection, run by Shanghai Zhongshan 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 5 inclusion and 5 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 13 May 2020. 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 Zhenyu Shi, PhD (021 6404 1990 ext. 2904, maxshizhenyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular Filtration Rate (time frame: Change from Baseline Glomerular Filtration Rate at 3 months). 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 13 May 2020.