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

NCT04545502 — Recruiting, 2000 participants, Vascutek Ltd.

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

RegistryNCT04545502, acronym PANTHER
StatusRecruiting
Study typeObservational
Enrollment2000 (Estimated)
SponsorVascutek Ltd. (Industry)
ConditionsAneurysm, Dissection, Aortic Root Aneurysm, Aortic Root Dissection, Carotid Artery Injuries, Aortic Arch, Bypass Extremity Graft, Occlusive Vascular Disease, Aortic Diseases
InterventionsGelsoft Plus Vascular Graft, Vascular Bypass Graft, Cardiovascular Patch, Gelweave Vascular Graft, Gelweave Valsalva Vascular Graft (Device)
Datesstart 2021-02-17, primary completion 2028-08-01 (estimated), completion 2037-01-01 (estimated), first posted 2020-09-11, last updated 2026-08-20
Locations30 sites in United States, Belgium, France, Germany, Hungary, Netherlands

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Gelsoft Plus - Straights and BifurcatedDevice: Gelsoft Plus Vascular GraftPatients 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-AnatomicalDevice: Vascular Bypass GraftAny 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 WallDevice: Cardiovascular PatchPatients 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, ThoracoabdominalDevice: Gelweave Vascular GraftPatients 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 - ValsalvaDevice: Gelweave Valsalva Vascular GraftPatients 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.
  • Gelsoft Plus Vascular Graft (Device), also known as Gelsoft Plus: 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), also known as Gelsoft Plus Extra Anatomical: 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), also known as Gelseal Patch, Gelsoft Patch, Thinwall Patch, Cardiovascular Fabrics: 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), also known as Gelweave: 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), also known as Gelweave Valsalva: 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.

+Outcome measures

Primary outcomes

  • Operative Death [1 Year]: 30 Day or In-Hospital Mortality
  • Graft Leakage [1 Year]: Device Failure: The presence of leakage or excessive bleeding through graft/patch

Secondary outcomes

  • Device Endpoints [1 Year]: Device failures, requirement for reintervention or device related adverse events
  • Procedural Endpoints [1 Year]: Rifampicin or heparin soaking, procedure related adverse events
  • Safety Endpoints [1 Year]: Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (30)

FacilityCityCountryStatus
University of Colorado AnschutzAurora, ColoradoUnited StatesRecruiting
University of South Florida - Tampa GeneralTampa, FloridaUnited StatesRecruiting
Indiana University HealthIndianapolis, IndianaUnited StatesRecruiting
Duke UniversityDurham, North CarolinaUnited StatesRecruiting
East Carolina UniversityGreenville, North CarolinaUnited StatesRecruiting
University Hospitals Cleveland Medical CenterCleveland, OhioUnited StatesRecruiting
Ohio State UniversityColumbus, OhioUnited StatesRecruiting
Lehigh Valley HospitalAllentown, PennsylvaniaUnited StatesRecruiting
University of PennsylvaniaPhiladelphia, PennsylvaniaUnited StatesRecruiting
Virginia Commonwealth UniversityRichmond, VirginiaUnited StatesRecruiting
UZ GentGhentBelgiumRecruiting
AZ Groeninge KortrijkKortrijkBelgiumRecruiting
UZ LeuvenLeuvenBelgiumRecruiting
CHU BordeauxBordeauxFranceWithdrawn
CHU Clermont FerrandClermont-FerrandFranceRecruiting
CHU de DijonDijonFranceRecruiting
CHU de LilleLilleFranceRecruiting
Hôpital Nord MarseilleMarseilleFranceRecruiting
CHU de RennesRennesFranceWithdrawn
Hôpitaux Universitaires de Strasbourg - Hôpital CivilStrasbourgFranceRecruiting
CHU de Toulouse - Hôpital RangueilToulouseFranceRecruiting
Charité BerlinBerlinGermanyRecruiting
Uniklinik BonnBonnGermanyRecruiting
UNIVERSITÄTSKLINIKUM FREIBURG/Bad KrozingenFreiburg im BreisgauGermanyRecruiting
UKE HamburgHamburgGermanyRecruiting
Heart Center LeipzigLeipzigGermanyRecruiting
Universitätsmedizin Mainz (University Hospital Mainz)MainzGermanyRecruiting
Ludwig-Maximilian Universität (LMU) KlinikumMunichGermanyRecruiting
Semmelweis University Heart and Vascular CenterBudapest, BudapestHungaryCompleted
Amphia Hospital (Ziekenhuis) BredaBredaNetherlandsActive not recruiting

My Notes