On-table Renal Perfusion Evaluation Renal Artery Stenosis or Obstruction

NCT03530748 | Unknown

• 1 other identifier: B2017-084
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Evaluate the feasibility for the on-table evaluation of the renal perfusion by using Syngo Dyna Parenchymal Blood Volume(PBV) Body;
2. 2.Explore the clinical benefits of this application during procedure to help the physician to determine the procedure endpoint.

Conditions

Renal Artery Stenosis; Aortic Dissection; Renal Perfusion; Renal Artery Obstruction

Outcome Measures

Primary Outcomes (1)

• Glomerular Filtration Rate

  The golden standard of renal function, tested by radionuclide imaging

  Change from Baseline Glomerular Filtration Rate at 3 months

Secondary Outcomes (2)

• Kidney Volume

  10 minutes pre- and post-endovascular therapy on table

• Mean Density of Contrast agent

  10 minutes pre- and post-endovascular therapy on table

Study Arms (1)

Patients with Renal Artery Stenosis

Patients with simple renal artery stenosis or aortic dissection with renal artery obstruction

Procedure: Endovascular therapy and Imaging Acquisition

Interventions

Endovascular therapy and Imaging Acquisition PROCEDURE

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

Patients with Renal Artery Stenosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Renal Artery Obstruction; Aortic Dissection

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Dissection, Blood Vessel; Aneurysm; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Zhenyu Shi, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenyu Shi, PhD

CONTACT

021 6404 1990; maxshizhenyu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 21, 2018
• Study Start: April 9, 2018
• Primary Completion: June 9, 2020
• Study Completion: December 31, 2020
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)