Actively Recruiting

Age: 18Years +
All Genders
ID04545502

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

Long-term Monitoring

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

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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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