VIABAHN BX Used in Fenestrated EVAR Study

NCT03310710 | Completed

• 1 other identifier: CAPCR 16-5084
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Technical success related the Viabahn BX stent graft when used as the branch device with a fenestrated EVAR graft.

  Successful deployment of the Viabahn BX stent graft without major adverse events, such as occlusion of the arteries, at the end of the fenestrated EVAR surgery.

  Intraoperative (End of EVAR surgery)

• Adverse event related to the Viabahn BX stent graft when used as the branch device with a fenestrated EVAR graft.

  Any stent related adverse event, such as occlusion of the stent and stent fracture

  12 months post surgery

Study Arms (1)

treatment with Viabahn BX stent

EXPERIMENTAL

Treatment with Viabahn BX stent as branch device in fenestrated EVAR

Device: Viabahn BX stent

Interventions

Viabahn BX stent DEVICE

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

treatment with Viabahn BX stent

Eligibility Criteria

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

You may qualify if:

• Fenestrated EVAR candidates as determined by the vascular interdisciplinary conference at UHN

You may not qualify if:

• Unable to provide informed consent (legally authorized representative is acceptable)
• Age \< 18
• Patients with a known hypersensitivity to heparin, including those patients who have had a previous incidence of HIT (heparin induced thrombocytopenia) type II.
• Currently participating in another investigative clinical study

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Kong Teng Tan, MD

  University Health Network, Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Treatment with Viabahn BX stents

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 16, 2017
• Study Start: February 13, 2017
• Primary Completion: October 17, 2018
• Study Completion: November 1, 2019
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

CA (1)