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

Recruiting

• Conditions: Bypass Extremity Graft; Dissection; Aortic Root Aneurysm; Aortic Root Dissection; Aortic Arch; Occlusive Vascular Disease; Aneurysm; Carotid Artery Injuries; Aortic Diseases
• Interventions: Device: Vascular Bypass Graft; Device: Gelsoft Plus Vascular Graft; Device: Gelweave Valsalva Vascular Graft; Device: Gelweave Vascular Graft; Device: Cardiovascular Patch

• Registration Number: NCT04545502
• Lead Sponsor: Vascutek Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-11
• Study Start: 2021-02-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2026-01
• Study Completion: 2033-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gelsoft Plus - Extra-Anatomical	Vascular Bypass Graft	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.
Gelsoft Plus - Straights and Bifurcated	Gelsoft Plus Vascular Graft	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.
Gelweave - Valsalva	Gelweave Valsalva Vascular Graft	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.
Gelweave - Abdominal, Thoracic, Thoracoabdominal	Gelweave Vascular Graft	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
Cardiovascular Patches - Gelseal, Gelsoft, Thin Wall	Cardiovascular Patch	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.

Primary Outcome Measures

Name	Time	Method
Operative Death	1 Year	30 Day or In-Hospital Mortality
Graft Leakage	1 Year	Device Failure: The presence of leakage or excessive bleeding through graft/patch

Secondary Outcome Measures

Name	Time	Method
Procedural Endpoints	1 Year	Rifampicin or heparin soaking, procedure related adverse events
Safety Endpoints	1 Year	Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke
Device Endpoints	1 Year	Device failures, requirement for reintervention or device related adverse events

Trial Locations

Locations (31)

University of Colorado Anschutz; 🇺🇸 Aurora, Colorado, United States

University of South Florida - Tampa General; 🇺🇸 Tampa, Florida, United States

Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

UZ Gent; 🇧🇪 Gent, Belgium

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

AZ Groeninge Kortrijk; 🇧🇪 Kortrijk, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Hamilton General; 🇨🇦 Hamilton, Ontario, Canada

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Dijon; 🇫🇷 Dijon, France

CHU de Lille; 🇫🇷 Lille, France

Hôpital Nord Marseille; 🇫🇷 Marseille, France

CHU de Rennes; 🇫🇷 Rennes, France

Hôpitaux Universitaires de Strasbourg - Hôpital Civil; 🇫🇷 Strasbourg, France

CHU de Toulouse - Hôpital Rangueil; 🇫🇷 Toulouse, France

Charité Berlin; 🇩🇪 Berlin, Germany

Uniklinik Bonn; 🇩🇪 Bonn, Germany

UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen; 🇩🇪 Freiburg, Germany

UKE Hamburg; 🇩🇪 Hamburg, Germany

Heart Center Leipzig; 🇩🇪 Leipzig, Germany

Universitätsmedizin Mainz (University Hospital Mainz); 🇩🇪 Mainz, Germany

Ludwig-Maximilian Universität (LMU) Klinikum; 🇩🇪 Munich, Germany

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary

Amphia Hospital (Ziekenhuis) Breda; 🇳🇱 Breda, Netherlands