PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
- Conditions
- Bypass Extremity GraftDissectionAortic Root AneurysmAortic Root DissectionAortic ArchOcclusive Vascular DiseaseAneurysmCarotid Artery InjuriesAortic 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
- 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.
-
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
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
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Scroll for more (21 remaining)University of Colorado Anschutz🇺🇸Aurora, Colorado, United StatesBrett ReecePrincipal Investigator