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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Patients who require treatment, or have already received treatment within the last 5 years, with the following commercially available Terumo Aortic knitted and woven grafts and cardiovascular patches: * Gelsoft Plus - Straights and Bifurcated * Gelsoft Plus - Extra-Anatomical * Cardiovascular Patches - Gelseal, Gelsoft and Thin Wall * Gelweave - Abdominal, Thoracic and Thoracoabdominal * Gelweave - Valsalva This is a non-interventional study and therefore only patients who would normally receive treatment with a Terumo Aortic devices as part of standard treatment at the participating institution can be enrolled.

Trial locations and contacts

30 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

About this study

Official title: A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

Conditions

Aneurysm, Dissection, Aortic Root Aneurysm, Aortic Root Dissection, Carotid Artery Injuries, Aortic Arch

Being tested

Gelsoft Plus Vascular Graft, Vascular Bypass Graft, Cardiovascular Patch, Gelweave Vascular Graft, Gelweave Valsalva Vascular Graft

Keywords

Vascular Surgery

Medical subject headings

Aneurysm, Aortic Root Aneurysm, Dissection, Ascending Aorta, Carotid Artery Injuries, Aortic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Gelsoft Plus Vascular GraftDevice

  Also called Gelsoft Plus

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

• Vascular Bypass GraftDevice

  Also called Gelsoft Plus Extra Anatomical

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

• Cardiovascular PatchDevice

  Also called Gelseal Patch, Gelsoft Patch, Thinwall Patch, Cardiovascular Fabrics

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

• Gelweave Vascular GraftDevice

  Also called Gelweave

  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 GraftDevice

  Also called Gelweave Valsalva

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Operative Death

   30 Day or In-Hospital Mortality

   Measured: 1 Year

2. Graft Leakage

   Device Failure: The presence of leakage or excessive bleeding through graft/patch

   Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted11 Sep 2020
2. Study start17 Feb 2021
3. Primary completionAug 2028 (estimated)
4. Study completionJan 2037 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for AneurysmStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.