PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches (PANTHER)

May 28, 2025 updated by: Vascutek Ltd.

A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Gent, Belgium, 9000
      • Kortrijk, Belgium, 8500
      • Leuven, Belgium, 3000
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Not yet recruiting
        • Hamilton General
        • Contact:
        • Principal Investigator:
          • Theodore Rapanos
  • France
      • Bordeaux, France
        • Withdrawn
        • CHU Bordeaux
      • Clermont-Ferrand, France
      • Dijon, France
        • Recruiting
        • CHU de DIJON
        • Contact:
          • Olivier Bouchot
        • Principal Investigator:
          • Olivier Bouchot
      • Lille, France, 59000
        • Recruiting
        • CHU de LILLE
        • Contact:
          • Mohamad Koussa
        • Principal Investigator:
          • Mohamad Koussa
      • Marseille, France, 13015
        • Recruiting
        • Hopital Nord Marseille
        • Contact:
          • Yves Alimi
        • Principal Investigator:
          • Yves Alimi
      • Rennes, France, 35033
        • Withdrawn
        • CHU de Rennes
      • Strasbourg, France, 67091
        • Recruiting
        • Hôpitaux Universitaires de Strasbourg - Hôpital Civil
        • Contact:
          • Nabil Chakfe
        • Principal Investigator:
          • Nabil Chakfe
      • Toulouse, France, 31059
        • Recruiting
        • CHU de Toulouse - Hôpital Rangueil
        • Contact:
          • Xavier Chaufour
        • Principal Investigator:
          • Xavier Chaufour
  • Germany
      • Berlin, Germany, 12200
      • Bonn, Germany, 53127
        • Recruiting
        • Uniklinik Bonn
        • Contact:
        • Principal Investigator:
          • Marwan Hamiko
      • Freiburg, Germany
      • Hamburg, Germany, 20251
        • Recruiting
        • UKE Hamburg
        • Contact:
        • Principal Investigator:
          • Sebastian Debus
      • Leipzig, Germany
        • Recruiting
        • Heart Center Leipzig
        • Contact:
          • Michael Borger
        • Principal Investigator:
          • Michael Borger
      • Mainz, Germany, 55131
        • Recruiting
        • Universitätsmedizin Mainz (University Hospital Mainz)
        • Contact:
          • Hazem El Beyrouti
        • Principal Investigator:
          • Hazem El Beyrouti
      • Munich, Germany, 81377
  • Hungary
      • Budapest, Hungary, 1122
        • Completed
        • Semmelweis University Heart and Vascular Center
  • Netherlands
      • Breda, Netherlands, 4818
        • Recruiting
        • Amphia Hospital (Ziekenhuis) Breda
        • Contact:
        • Principal Investigator:
          • L. van der Laan
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz
        • Contact:
          • Brett Reece
        • Principal Investigator:
          • Brett Reece
    • Florida
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University of South Florida - Tampa General
        • Contact:
        • Principal Investigator:
          • Murray Shames
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health
        • Contact:
        • Principal Investigator:
          • Joel Corvera
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Chad Hughes
      • Greenville, North Carolina, United States, 27858
        • Recruiting
        • East Carolina University
        • Contact:
        • Principal Investigator:
          • Benjamin Degner
    • Ohio
      • Cleveland, Ohio, United States, 44106
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Contact:
          • Kristine Orion
        • Principal Investigator:
          • Kristine Orion
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital
        • Principal Investigator:
          • James Wu
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19105
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Daniel Newton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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.
Other Names:
  • Gelsoft Plus
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.
Device: 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.
Other Names:
  • Gelsoft Plus Extra Anatomical
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.
Device: Cardiovascular Patch
Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.
Other Names:
  • Gelseal Patch
  • Gelsoft Patch
  • Thinwall Patch
  • Cardiovascular Fabrics
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
Device: 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.
Other Names:
  • Gelweave
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.
Device: 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 Names:
  • Gelweave Valsalva

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Operative Death
Time Frame: 1 Year
30 Day or In-Hospital Mortality
1 Year
Graft Leakage
Time Frame: 1 Year
Device Failure: The presence of leakage or excessive bleeding through graft/patch
1 Year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device Endpoints
Time Frame: 1 Year
Device failures, requirement for reintervention or device related adverse events
1 Year
Procedural Endpoints
Time Frame: 1 Year
Rifampicin or heparin soaking, procedure related adverse events
1 Year
Safety Endpoints
Time Frame: 1 Year
Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vascutek Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PANTHER-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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