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Registry collecting data on Terumo Aortic grafts and patches

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

Observational Vascutek Ltd. · NCT04545502

This study is collecting information on the safety and effectiveness of Terumo Aortic grafts and patches used in heart procedures to help improve patient care.

Quick facts

Study typeObservational
Enrollment2000 (estimated)
Ages18 Years and up
SexAll
SponsorVascutek Ltd. Industry-sponsored
Locations31 sites (Aurora, Colorado and 30 other locations)
Trial IDNCT04545502 on ClinicalTrials.gov

What this trial studies

This registry aims to gather safety and performance data on commercially available Terumo Aortic knitted and woven grafts, as well as cardiovascular patches used in standard clinical practice. Data will be collected both retrospectively from patients who have already undergone procedures and prospectively from new patients requiring treatment. The study will include patients who meet specific eligibility criteria, ensuring comprehensive data collection over time.

Who should consider this trial

Good fit: Ideal candidates for this study are patients requiring treatment with Terumo Aortic grafts or patches and who meet the study's inclusion criteria.

Not a fit: Patients who do not require treatment with the specified devices or who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of the safety and effectiveness of Terumo Aortic devices, potentially leading to improved patient outcomes in vascular surgeries.

How similar studies have performed: While this study is observational and focuses on specific devices, similar registries have shown success in collecting valuable data that informs clinical practices.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Aurora, Colorado and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AneurysmDissectionAortic Root AneurysmAortic Root DissectionCarotid Artery InjuriesAortic ArchBypass Extremity GraftOcclusive Vascular Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.