PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

Launched by VASCUTEK LTD. · Sep 3, 2020

Keywords

ClinConnect Summary

The PANTHER Study is a clinical trial designed to gather important information about the safety and effectiveness of certain medical devices made by Terumo Aortic. These devices include knitted and woven grafts and cardiovascular patches, which are used to treat various conditions affecting blood vessels, such as aneurysms and dissections. The study will collect data both from patients who are currently being treated and from those who were treated in the past, helping doctors understand how well these devices work in everyday clinical practice.

To be eligible for this study, participants must be at least 18 years old and need treatment with the devices being studied. They should also be willing to attend follow-up appointments and provide consent for their data to be collected. It’s important to note that patients who have had their surgery within the last five years and have at least one year of follow-up information available can participate. Participants can expect to share their medical history and undergo routine check-ups related to their treatment. This study aims to improve the care provided to patients with vascular conditions, ensuring that the devices used are safe and effective.

Gender

ALL

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