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AneurysmDevice

What this study is

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.

What's being tested

  • Gelsoft Plus Vascular Graft

    Intervention · DEVICE

    Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.

  • Vascular Bypass Graft

    Intervention · DEVICE

    Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.

  • Cardiovascular Patch

    Intervention · DEVICE

    Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.

  • Gelweave Vascular Graft

    Intervention · DEVICE

    The Gelweave woven polyester vascular graft allows replacement of large sections of arteries and, following anastomosis to the native blood vessel, provides a stable conduit for blood flow.

  • Gelweave Valsalva Vascular Graft

    Intervention · DEVICE

    This woven polyester graft is designed to match the aortic root anatomy and is implanted to repair or replace a portion of the aorta in case of an aneurysm, dissection or coarctation at the level of the thoracic aorta.

Study details

Official title
A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Sponsor
Vascutek Ltd.
Conditions
Aneurysm · Dissection · Aortic Root Aneurysm · Aortic Root Dissection · Carotid Artery Injuries · Aortic Arch · Bypass Extremity Graft · Occlusive Vascular Disease · Aortic Diseases
Enrolling
2,000 people
Starts
2021-02-17
Est. completion
2037-01
Record
View on ClinicalTrials.gov ↗