Actively Recruiting
A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Led by Vascutek Ltd. · Updated on 2025-06-03
2000
Participants Needed
31
Research Sites
526 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting safety and performance data on various Terumo Aortic knitted and woven grafts, as well as cardiovascular patches used in standard medical practice. This includes patients treated for aneurysmal or occlusive vascular diseases and related conditions such as aortic root aneurysm, dissection, carotid artery injuries, and aortic arch issues. The study gathers data both retrospectively and prospectively to understand the outcomes of these devices in real-world use. The study involves several types of vascular devices including Gelsoft Plus vascular grafts, vascular bypass grafts, cardiovascular patches, Gelweave vascular grafts, and Gelweave Valsalva vascular grafts. These devices are implanted in various arteries, including the abdominal and thoracic aorta, peripheral arteries, and carotid arteries, for repairs such as bypasses, vessel repair, and aortic root procedures. Patients who have received or will receive these devices within the last five years or from the study start onwards are included. Participants provide data through routine clinical care and follow-up. Researchers monitor key outcomes such as operative death and graft leakage within one year, along with device, procedural, and safety endpoints. The study aims to collect information from both past and ongoing patients to better understand the performance of these vascular devices in everyday clinical settings. The study is expected to continue collecting data through January 2037.
CONDITIONS
Brief Title
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient meets the minimum age as per local regulations at time of consent
- Patient requires treatment with study device(s) according to the instructions for use
- Patient is willing and able to comply with all standard care procedures and study visits
- Patient or their legally authorised representative has given written informed consent, including consent to collect retrospective data
- For prospective emergency patients, retrospective consent is acceptable
- For retrospective patients deceased at enrollment, local ethics committee regulations are followed
- Retrospective patients have at least 1 year of post-operative follow-up data or complete data to death
- Patient implant date is no more than 5 years before study start date
You will not qualify if you...
- Patient is unable or unwilling to comply with standard care procedures or follow-up
- Patient is contraindicated according to the device instructions for use
- Patient has other medical, social, or psychological issues that prevent receiving treatment or undergoing study procedures in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years before study enrollment and ongoing from study launch
Participants receive implantation of Terumo aortic knitted and woven grafts, or cardiovascular patches as part of their routine vascular repair treatment.
Data collected from medical records; no additional visits required for implantation
Duration - At least 1 year post-implantation and up to study completion
Participants who have received grafts or patches are observed to assess outcomes such as operative death, graft leakage, device, procedural, and safety endpoints over 1 year and beyond.
Follow-up visits according to standard care; frequency varies by patient
Trial Site Locations
Total: 31 locations
1
University of Colorado Anschutz
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of South Florida - Tampa General
Tampa, Florida, United States, 33620
Actively Recruiting
3
Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
5
East Carolina University
Greenville, North Carolina, United States, 27858
Actively Recruiting
6
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
7
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
8
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
9
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19105
Actively Recruiting
10
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
11
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
12
AZ Groeninge Kortrijk
Kortrijk, Belgium, 8500
Actively Recruiting
13
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
14
Hamilton General
Hamilton, Ontario, Canada, L8L 2X2
Not Yet Recruiting
15
CHU Bordeaux
Bordeaux, France
Withdrawn
16
CHU Clermont Ferrand
Clermont-Ferrand, France
Actively Recruiting
17
CHU de Dijon
Dijon, France
Actively Recruiting
18
CHU de Lille
Lille, France, 59000
Actively Recruiting
19
Hôpital Nord Marseille
Marseille, France, 13015
Actively Recruiting
20
CHU de Rennes
Rennes, France, 35033
Withdrawn
21
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
Strasbourg, France, 67091
Actively Recruiting
22
CHU de Toulouse - Hôpital Rangueil
Toulouse, France, 31059
Actively Recruiting
23
Charité Berlin
Berlin, Germany, 12200
Actively Recruiting
24
Uniklinik Bonn
Bonn, Germany, 53127
Actively Recruiting
25
UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen
Freiburg im Breisgau, Germany
Actively Recruiting
26
UKE Hamburg
Hamburg, Germany, 20251
Actively Recruiting
27
Heart Center Leipzig
Leipzig, Germany
Actively Recruiting
28
Universitätsmedizin Mainz (University Hospital Mainz)
Mainz, Germany, 55131
Actively Recruiting
29
Ludwig-Maximilian Universität (LMU) Klinikum
Munich, Germany, 81377
Actively Recruiting
30
Semmelweis University Heart and Vascular Center
Budapest, Budapest, Hungary, 1122
Completed
31
Amphia Hospital (Ziekenhuis) Breda
Breda, Netherlands, 4818
Actively Recruiting
Research Team
C
Clinical Study Manager
T
TA UK Clinical Research
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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