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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVascutek Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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 design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

2,000 Participants
are divided into 5 treatment groups
Group A: Gelsoft Plus - Straights and Bifurcated1 intervention
Group B: Gelsoft Plus - Extra-Anatomical1 intervention
Group C: Cardiovascular Patches - Gelseal, Gelsoft, Thin Wall1 intervention
Group D: Gelweave - Abdominal, Thoracic, Thoracoabdominal1 intervention
Group E: Gelweave - Valsalva1 intervention

Trial outcomes

Primary outcomes

1

Operative Death

30 Day or In-Hospital Mortality

Time frame
1 Year
2

Graft Leakage

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

Time frame
1 Year

Secondary outcomes

1

Device Endpoints

Device failures, requirement for reintervention or device related adverse events

Time frame
1 Year
2

Procedural Endpoints

Rifampicin or heparin soaking, procedure related adverse events

Time frame
1 Year
3

Safety Endpoints

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

Time frame
1 Year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.