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ID04545502

Study to Collect Safety and Performance Data on Terumo Aortic Knitted and Woven Grafts and Cardiovascular Patches Including Gelsoft Plus and Gelweave Devices in Patients With Aneurysmal or Occlusive Vascular Disease

Led by Vascutek Ltd. · Updated on 2025-06-03

2000

Participants Needed

31

Research Sites

526 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are collecting safety and performance data on various Terumo Aortic knitted and woven grafts, as well as cardiovascular patches used in standard medical practice. This includes patients treated for aneurysmal or occlusive vascular diseases and related conditions such as aortic root aneurysm, dissection, carotid artery injuries, and aortic arch issues. The study gathers data both retrospectively and prospectively to understand the outcomes of these devices in real-world use. The study involves several types of vascular devices including Gelsoft Plus vascular grafts, vascular bypass grafts, cardiovascular patches, Gelweave vascular grafts, and Gelweave Valsalva vascular grafts. These devices are implanted in various arteries, including the abdominal and thoracic aorta, peripheral arteries, and carotid arteries, for repairs such as bypasses, vessel repair, and aortic root procedures. Patients who have received or will receive these devices within the last five years or from the study start onwards are included. Participants provide data through routine clinical care and follow-up. Researchers monitor key outcomes such as operative death and graft leakage within one year, along with device, procedural, and safety endpoints. The study aims to collect information from both past and ongoing patients to better understand the performance of these vascular devices in everyday clinical settings. The study is expected to continue collecting data through January 2037.

CONDITIONS

Brief Title

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

Research Team

C

Clinical Study Manager

T

TA UK Clinical Research

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