About this trial

The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.

Data will be collected both retrospectively and prospectively.

Eligibility criteria

Qualifiers

Patient meets the minimum age as per local regulations at time of consent

Patient requires treatment with study device(s) according to the IFU(s)

Patient is willing and able to comply with all SOC procedures and study visits

Patient or their legally authorised representative (LAR) has given written informed consent to participate in study, including consent to collect data retrospectively

Disqualifiers

Patient is unable or unwilling to comply with the SOC procedures or follow-up regime

Patient is contraindicated per the device IFU

Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post-procedure

Trial design

Treatments tested in this trial

  • Gelsoft Plus Vascular Graft
  • Vascular Bypass Graft
  • Cardiovascular Patch
  • Gelweave Vascular Graft
  • Gelweave Valsalva Vascular Graft

Treatment groups

2,000 Participants
are divided into 5 treatment groups

Locations

31
Belgium
UZ Gent9000, Ghent Belgium
AZ Groeninge Kortrijk8500, Kortrijk Belgium
UZ Leuven3000, Leuven Belgium
Canada
Hamilton GeneralL8L 2X2, HamiltonOntario, Canada

Sponsors and collaborators

Vascutek Ltd.

Lead sponsor