NCT04545502 · Vascutek Ltd.
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
(PANTHER)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Aurora, Colorado
- Tampa, Florida
- Indianapolis, Indiana
- Durham, North Carolina
- Greenville, North Carolina
- Cleveland, Ohio
- Columbus, Ohio
- Allentown, Pennsylvania
- Philadelphia, Pennsylvania
- Richmond, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2025 · Source of record for eligibility and locations