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On-table Renal Perfusion Evaluation Renal Artery Stenosis or Obstruction

On-table Renal Perfusion Evaluation for Patients With Renal Artery Stenosis or Aortic Dissection With Renal Artery Obstruction

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03530748
Enrollment
30
Registered
2018-05-21
Start date
2018-04-09
Completion date
2020-12-31
Last updated
2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Dissection, Renal Artery Obstruction, Renal Artery Stenosis, Renal Perfusion

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.

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.

Interventions

PROCEDUREEndovascular therapy and Imaging Acquisition

1. Endovascular repair for renal artery stenosis; 2. Parenchymal Blood Volume(PBV) acquisition and analysis for target kidney

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Glomerular Filtration RateChange from Baseline Glomerular Filtration Rate at 3 monthsThe golden standard of renal function, tested by radionuclide imaging

Secondary

MeasureTime frameDescription
Kidney Volume10 minutes pre- and post-endovascular therapy on tableTotal blood volume of kidney, tested by PBV
Mean Density of Contrast agent10 minutes pre- and post-endovascular therapy on tableRenal blood perfusion, tested by PBV

Countries

China

Contacts

Primary ContactZhenyu Shi, PhD
maxshizhenyu@163.com021 6404 1990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026