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VIABAHN BX Used in Fenestrated EVAR Study

NCT03310710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-28

No results posted yet for this study

Summary

Fenestrated endovascular abdominal aortic aneurysm repair (FEVAR) is a procedure to treat abdominal aortic aneurysms which are not amenable to conventional repair or stenting. A stent is placed in the aorta and confines blood flow to a normal diameter lumen to remove pressure on the diseased aortic wall. Fenestrations (custom holes in the graft) are necessary to maintain blood flow to abdominal organs when the aneurysm sac extends to far proximally. These fenestrations are then typically aligned with their respective vessels using covered stents. These stents also help keep the arteries open.

Unfortunately some of the stents currently used occlude either immediately or over time, which can lead to organ failure, morbidity and death. A recent advancement in stent design has heparin bonded to the stent surface which prevents clot from forming. This new design has been shown to help maintain stent patency in other parts of the body. The investigators believe it may do the same for FEVAR patients. The proposed study is a 20-patient pilot to assess the safety of substituting a heparin bonded stent graft for FEVAR branches over a period of one year. Patients who are deemed eligible for FEVAR by a UHN multidisciplinary vascular conference will be recruited to the study. All the branches in their FEVAR will use the Viabahn BX stent in place of the current standard of care stent. They will then be followed per the standard of care for one year. Adverse events will be recorded and the rate of occlusion will be assessed based on CT imaging.

The investigators hypothesize that using heparin bonded stent grafts is safe and they will have a low rate of occlusion.

Conditions

  • Aortic Aneurysm, Abdominal

Interventions

DEVICE

Viabahn BX stent

Viabahn BX stent graft used as the branch device with a fenestrated EVAR graft

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Kong Teng Tan, MD · University Health Network, Toronto General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-13
Primary Completion
2018-10-17
Completion
2019-11-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03310710 on ClinicalTrials.gov