PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
PANTHER
A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
1 other identifier
observational
2,000
7 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2020
CompletedFirst Posted
Study publicly available on registry
September 11, 2020
CompletedStudy Start
First participant enrolled
February 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2037
June 3, 2025
May 1, 2025
5.8 years
September 3, 2020
May 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Operative Death
30 Day or In-Hospital Mortality
1 Year
Graft Leakage
Device Failure: The presence of leakage or excessive bleeding through graft/patch
1 Year
Secondary Outcomes (3)
Device Endpoints
1 Year
Procedural Endpoints
1 Year
Safety Endpoints
1 Year
Study Arms (5)
Gelsoft Plus - Straights and Bifurcated
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.
Gelsoft Plus - Extra-Anatomical
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.
Cardiovascular Patches - Gelseal, Gelsoft, Thin Wall
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.
Gelweave - Abdominal, Thoracic, Thoracoabdominal
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
Gelweave - Valsalva
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.
Interventions
Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.
Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.
The Gelweave woven polyester vascular graft allows replacement of large sections of arteries and, following anastomosis to the native blood vessel, provides a stable conduit for blood flow.
This woven polyester graft is designed to match the aortic root anatomy and is implanted to repair or replace a portion of the aorta in case of an aneurysm, dissection or coarctation at the level of the thoracic aorta.
Eligibility Criteria
Patients who require treatment, or have already received treatment within the last 5 years, with the following commercially available Terumo Aortic knitted and woven grafts and cardiovascular patches: * Gelsoft Plus - Straights and Bifurcated * Gelsoft Plus - Extra-Anatomical * Cardiovascular Patches - Gelseal, Gelsoft and Thin Wall * Gelweave - Abdominal, Thoracic and Thoracoabdominal * Gelweave - Valsalva This is a non-interventional study and therefore only patients who would normally receive treatment with a Terumo Aortic devices as part of standard treatment at the participating institution can be enrolled.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vascutek Ltd.lead
Study Sites (31)
University of Colorado Anschutz
Aurora, Colorado, 80045, United States
University of South Florida - Tampa General
Tampa, Florida, 33620, United States
Indiana University Health
Indianapolis, Indiana, 46202, United States
Duke University
Durham, North Carolina, 27705, United States
East Carolina University
Greenville, North Carolina, 27858, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Ohio State University
Columbus, Ohio, 43210, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19105, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
UZ Gent
Ghent, 9000, Belgium
AZ Groeninge Kortrijk
Kortrijk, 8500, Belgium
UZ Leuven
Leuven, 3000, Belgium
Hamilton General
Hamilton, Ontario, L8L 2X2, Canada
CHU Bordeaux
Bordeaux, France
CHU Clermont Ferrand
Clermont-Ferrand, France
CHU de Dijon
Dijon, France
CHU de Lille
Lille, 59000, France
Hôpital Nord Marseille
Marseille, 13015, France
CHU de Rennes
Rennes, 35033, France
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
Strasbourg, 67091, France
CHU de Toulouse - Hôpital Rangueil
Toulouse, 31059, France
Charité Berlin
Berlin, 12200, Germany
Uniklinik Bonn
Bonn, 53127, Germany
UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen
Freiburg im Breisgau, Germany
UKE Hamburg
Hamburg, 20251, Germany
Heart Center Leipzig
Leipzig, Germany
Universitätsmedizin Mainz (University Hospital Mainz)
Mainz, 55131, Germany
Ludwig-Maximilian Universität (LMU) Klinikum
Munich, 81377, Germany
Semmelweis University Heart and Vascular Center
Budapest, Budapest, 1122, Hungary
Amphia Hospital (Ziekenhuis) Breda
Breda, 4818, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2020
First Posted
September 11, 2020
Study Start
February 17, 2021
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2037
Last Updated
June 3, 2025
Record last verified: 2025-05