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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
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

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
Primary Outcome Measures
NameTimeMethod
Operative Death1 Year

30 Day or In-Hospital Mortality

Graft Leakage1 Year

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

Secondary Outcome Measures
NameTimeMethod
Procedural Endpoints1 Year

Rifampicin or heparin soaking, procedure related adverse events

Safety Endpoints1 Year

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

Device Endpoints1 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

Lehigh Valley Hospital

🇺🇸

Allentown, Pennsylvania, United States

University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

Virginia Commonwealth University

🇺🇸

Richmond, Virginia, United States

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University of Colorado Anschutz
🇺🇸Aurora, Colorado, United States
Brett Reece
Principal Investigator

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