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

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.

Study Overview

• Status: Unknown
• Conditions: Renal Artery Obstruction; Aortic Dissection; Renal Artery Stenosis; Renal Perfusion
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glomerular Filtration Rate	The golden standard of renal function, tested by radionuclide imaging	Change from Baseline Glomerular Filtration Rate at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney Volume	Total blood volume of kidney, tested by PBV	10 minutes pre- and post-endovascular therapy on table
Mean Density of Contrast agent	Renal blood perfusion, tested by PBV	10 minutes pre- and post-endovascular therapy on table

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Anticipated): June 9, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Aneurysm; Constriction, Pathologic; Renal Artery Obstruction; Aneurysm, Dissecting
• Other Study ID Numbers: B2017-084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No