NCT04545502 PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
| NCT ID | NCT04545502 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vascutek Ltd. |
| Condition | Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2021-02-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2021-02-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04545502 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04545502 currently recruiting?
Yes, NCT04545502 is actively recruiting participants. Contact the research team at r.smith1@terumoaortic.com for enrollment information.
Where is the NCT04545502 trial being conducted?
This trial is being conducted at Aurora, United States, Tampa, United States, Indianapolis, United States, Durham, United States and 11 additional locations.
Who is sponsoring the NCT04545502 clinical trial?
NCT04545502 is sponsored by Vascutek Ltd.. The trial plans to enroll 2,000 participants.