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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Vascutek Ltd.
Study ID
NCT04545502
Status
Recruiting
Apply to this trial

Conditions

  • Aneurysm
  • Aortic Arch
  • Aortic Diseases
  • Aortic Root Aneurysm
  • Aortic Root Dissection
  • Bypass Extremity Graft
  • Carotid Artery Injuries
  • Dissection
  • Occlusive Vascular Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gelsoft Plus Vascular Graft — DEVICE
    Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
  • Vascular Bypass Graft — DEVICE
    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 — DEVICE
    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 — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 17, 2021
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Jan 31, 2037

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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
  • Arm: 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.

Primary Outcome Measure

Operative Death [ Time Frame: 1 Year ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of Colorado AnschutzAuroraColorado80045
Brett Reece
Brett Reece (PRINCIPAL_INVESTIGATOR)
University of South Florida - Tampa GeneralTampaFlorida33620
Murray Shames (PRINCIPAL_INVESTIGATOR)
Indiana University HealthIndianapolisIndiana46202
Joel Corvera, MD
[email protected]
Joel Corvera (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27705
Chad Hughes (PRINCIPAL_INVESTIGATOR)
East Carolina UniversityGreenvilleNorth Carolina27858
Benjamin Degner (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Terence Semenec
[email protected]
Jae Cho (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43210
Kristine Orion
Kristine Orion (PRINCIPAL_INVESTIGATOR)
Lehigh Valley HospitalAllentownPennsylvania18103
James Wu (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19105
Eric Suchanec
[email protected]
Nimesh Desai (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298
Daniel Newton, MD
[email protected]
Daniel Newton (PRINCIPAL_INVESTIGATOR)

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University of Colorado Anschutz· Aurora, COUniversity of South Florida - Tampa General· Tampa, FLIndiana University Health· Indianapolis, INDuke University· Durham, NCEast Carolina University· Greenville, NCUniversity Hospitals Cleveland Medical Center· Cleveland, OH

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