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ClinicalTrials.gov ID

NCT04545502

Lead Sponsor

Vascutek Ltd.INDUSTRY

Overall Status

Recruiting

Study Type

Observational

Enrollment

2,000Estimated

Last Update Posted

Aug 20, 2026Actual

Start Date

Feb 17, 2021Actual

Primary Completion Date

Aug 2028Estimated

Completion Date

Jan 2037Estimated

Official Title

A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

Brief Summary

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.

• Aneurysm
• Dissection
• Aortic Root Aneurysm
• Aortic Root Dissection
• Carotid Artery Injuries
• Aortic Arch
• Bypass Extremity Graft
• Occlusive Vascular Disease
• Aortic Diseases

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Patients must meet all of the following inclusion criteria in order to be eligible for inclusion in the study:

All Patients:

• 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

  • For prospective emergency patients, retrospective consent is permissible
  • For retrospective patients who are deceased at time of enrollment, local EC regulations relating to consent process should be followed.

Retrospective Patients only:

• Patient has a minimum of 1 year post-operative follow-up data available, or complete data to death.
• Patient implant date is no more than 5 years prior to study start date.

Exclusion Criteria:

• Any patient who meets any of the following exclusion criteria will be excluded from participation in the study:

  • 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

Observational Model

Cohort

Time Perspective

Other

Lead Sponsor

Vascutek Ltd.INDUSTRY

nathalie.moreels@uzgent.be