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NCT Number: NCT04545502

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

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.

Recruiting

Interested in participating?

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gelsoft Plus Vascular Graft

Device

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

Other names: Gelsoft Plus

Vascular Bypass Graft

Device

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

Other names: Gelsoft Plus Extra Anatomical

Cardiovascular Patch

Device

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

Other names: Gelseal Patch, Gelsoft Patch, Thinwall Patch, Cardiovascular Fabrics

Gelweave Vascular Graft

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.

Other names: Gelweave

Gelweave Valsalva Vascular Graft

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.

Other names: Gelweave Valsalva

Primary outcomes

  1. Operative Death

    Time frame: 1 Year

    30 Day or In-Hospital Mortality

  2. Graft Leakage

    Time frame: 1 Year

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

Secondary outcomes

  1. Device Endpoints

    Time frame: 1 Year

    Device failures, requirement for reintervention or device related adverse events

  2. Procedural Endpoints

    Time frame: 1 Year

    Rifampicin or heparin soaking, procedure related adverse events

  3. Safety Endpoints

    Time frame: 1 Year

    Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Study Manager

CONTACT

[email protected]

+44 141 343 0194

TA UK Clinical Research

CONTACT

[email protected]

+44 141 812 5555

Sponsors and collaborators

Lead sponsor

Vascutek Ltd.

Industry

Registry information

Official study title

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

Acronym: PANTHER

Important dates

Study start
2021
Primary completion
2026
Study completion
2037
First posted
Sep 11, 2020
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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