Registry collecting data on Terumo Aortic grafts and patches

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Colorado Anschutz
  Aurora, Colorado, United States Recruiting
• University of South Florida - Tampa General
  Tampa, Florida, United States Recruiting
• Indiana University Health
  Indianapolis, Indiana, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting
• East Carolina University
  Greenville, North Carolina, United States Recruiting
• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Clinical Study Manager
• Email: r.smith1@terumoaortic.com
• Phone: +44 141 343 0194

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.