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

April 9, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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 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        • Withdrawn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
        • Hôpital Nord Marseille
        • Contact:
          • Yves Alimi
        • Principal Investigator:
          • Yves Alimi
      • Rennes, France, 35033
        • Withdrawn
        • Chu de Rennes
      • Strasbourg, France, 67091
        • Recruiting
        • Hopitaux Universitaires de Strasbourg - Hopital 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
  • 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:
          • Dean Yamaguchi
    • 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

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
Intervention / Treatment
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

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

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

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)

February 17, 2021

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2033

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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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