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

Vascutek

Status: Enrolling

Conditions: Aneurysm; Occlusive Vascular Disease; Bypass Extremity Graft; Carotid Artery Injuries; Aortic Diseases; Aortic Arch; Aortic Root Aneurysm; Aortic Root Dissection; Dissection

Treatments: Device: Gelweave Valsalva Vascular Graft; Device: Gelsoft Plus Vascular Graft; Device: Vascular Bypass Graft; Device: Gelweave Vascular Graft; Device: Cardiovascular Patch

Study type: Observational

Funder types: Industry

Identifiers

NCT04545502

PANTHER-001

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 5 patient groups

Gelsoft Plus - Straights and Bifurcated

Description:

Patients with aneurysmal or occlusive disease, including those with connective tissue disorders who have received/will receive a Gelsoft Plus Straight or Bifurcate, implanted in the abdomen or peripheral arteries in the last 5 years and from study launch onwards.

Treatment:

Device: Gelsoft Plus Vascular Graft

Gelsoft Plus - Extra-Anatomical

Description:

Any patients who have received/will receive a Gelsoft Plus Extra-Anatomical supported or unsupported graft, implanted for: axillary-femoral bypass, femoral-femoral bypass or femoral-popliteal bypass in the last 5 years and from study launch onwards.

Treatment:

Device: Vascular Bypass Graft

Cardiovascular Patches - Gelseal, Gelsoft, Thin Wall

Description:

Patients who have been implanted with/require a cardiovascular patch for: thoracic vessel repair with a Gelseal Cardiovascular Patch; abdominal or peripheral vessel repair with a Gelsoft Cardiovascular Patch; or carotid endarterectomy with a Thin Wall Carotid Patch in the last 5 years and from study launch onwards.

Treatment:

Device: Cardiovascular Patch

Gelweave - Abdominal, Thoracic, Thoracoabdominal

Description:

Patients who, due to either aneurysmal or occlusive disease, have had/require vascular repair of one of the following, implanted in the last 5 years and from study launch onwards: * Abdominal aorta, arteries arising from the abdominal aorta or peripheral arteries including femoral, iliac and popliteal arteries. * Thoracic aorta or arteries arising from the thoracic aorta. * Abdominal and thoracic aorta requiring a thoracoabdominal repair

Treatment:

Device: Gelweave Vascular Graft

Gelweave - Valsalva

Description:

Patients who have had/require aortic root repair using valve sparing or valve replacing procedures, with or without replacement of the aortic arch, implanted in the last 5 years and from study launch onwards.

Treatment:

Device: Gelweave Valsalva Vascular Graft