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On-table Renal Perfusion Evaluation Renal Artery Stenosis or Obstruction

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ClinicalTrials.gov Identifier: NCT03530748
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Zhenyu Shi, Shanghai Zhongshan Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Renal Artery Stenosis Aortic Dissection Renal Perfusion Renal Artery Obstruction Procedure: Endovascular therapy and Imaging Acquisition

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
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: On-table Renal Perfusion Evaluation for Patients With Renal Artery Stenosis or Aortic Dissection With Renal Artery Obstruction
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : June 9, 2020
Estimated Study Completion Date : December 31, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with Renal Artery Stenosis
Patients with simple renal artery stenosis or aortic dissection with renal artery obstruction
 Procedure: Endovascular therapy and Imaging Acquisition
  1. Endovascular repair for renal artery stenosis;
  2. Parenchymal Blood Volume(PBV) acquisition and analysis for target kidney


Outcome Measures
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Primary Outcome Measures :
  1. Glomerular Filtration Rate [ Time Frame: Change from Baseline Glomerular Filtration Rate at 3 months ]
    The golden standard of renal function, tested by radionuclide imaging


Secondary Outcome Measures :
  1. Kidney Volume [ Time Frame: 10 minutes pre- and post-endovascular therapy on table ]
    Total blood volume of kidney, tested by PBV

  2. Mean Density of Contrast agent [ Time Frame: 10 minutes pre- and post-endovascular therapy on table ]
    Renal blood perfusion, tested by PBV


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530748


Contacts
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Contact: Zhenyu Shi, PhD 021 6404 1990 ext 2904 maxshizhenyu@163.com

Locations
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China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhenyu Shi, PhD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Zhenyu Shi, PhD Fudan University
More Information
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Responsible Party: Zhenyu Shi, Clinical Professor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03530748    
Other Study ID Numbers: B2017-084
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Artery Obstruction
Aneurysm, Dissecting
Constriction, Pathologic
Pathological Conditions, Anatomical
Aneurysm
 Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases