PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
NCT ID: NCT04545502
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2021-02-17
2037-01-31
Brief Summary
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Data will be collected both retrospectively and prospectively.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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 Vascular Graft
Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
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.
Vascular Bypass Graft
Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.
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.
Cardiovascular Patch
Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.
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 Vascular Graft
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.
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.
Gelweave Valsalva Vascular Graft
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.
Interventions
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Gelsoft Plus Vascular Graft
Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
Vascular Bypass Graft
Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.
Cardiovascular Patch
Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.
Gelweave Vascular Graft
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.
Gelweave Valsalva Vascular Graft
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Vascutek Ltd.
INDUSTRY
Responsible Party
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Locations
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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
UZ Gent
Ghent, , Belgium
AZ Groeninge Kortrijk
Kortrijk, , Belgium
UZ Leuven
Leuven, , Belgium
Hamilton General
Hamilton, Ontario, Canada
CHU Bordeaux
Bordeaux, , France
CHU Clermont Ferrand
Clermont-Ferrand, , France
CHU de Dijon
Dijon, , France
CHU de Lille
Lille, , France
Hôpital Nord Marseille
Marseille, , France
CHU de Rennes
Rennes, , France
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
Strasbourg, , France
CHU de Toulouse - Hôpital Rangueil
Toulouse, , France
Charité Berlin
Berlin, , Germany
Uniklinik Bonn
Bonn, , Germany
UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen
Freiburg im Breisgau, , Germany
UKE Hamburg
Hamburg, , Germany
Heart Center Leipzig
Leipzig, , Germany
Universitätsmedizin Mainz (University Hospital Mainz)
Mainz, , Germany
Ludwig-Maximilian Universität (LMU) Klinikum
Munich, , Germany
Semmelweis University Heart and Vascular Center
Budapest, Budapest, Hungary
Amphia Hospital (Ziekenhuis) Breda
Breda, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Brett Reece
Role: primary
Kristine Orion
Role: primary
Olivier Bouchot
Role: primary
Mohamad Koussa
Role: primary
Yves Alimi
Role: primary
Nabil Chakfe
Role: primary
Xavier Chaufour
Role: primary
Michael Borger
Role: primary
Hazem El Beyrouti
Role: primary
Other Identifiers
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PANTHER-001
Identifier Type: -
Identifier Source: org_study_id
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