Clinical trial NCT04545502: PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Official title: A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aneurysm
Dissection
Aortic Root Aneurysm
Aortic Root Dissection
Carotid Artery Injuries
Aortic Arch
Bypass Extremity Graft
Occlusive Vascular Disease
Aortic Diseases
Keywords: Vascular Surgery
Lead sponsor: Vascutek Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Operative Death
timeFrame: 1 Year
measure: Graft Leakage
timeFrame: 1 Year
Secondary outcomes:
measure: Device Endpoints
timeFrame: 1 Year
measure: Procedural Endpoints
timeFrame: 1 Year
measure: Safety Endpoints
timeFrame: 1 Year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
city: Tampa
country: United States
facility: University of South Florida - Tampa General
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge Kortrijk
city: Leuven
country: Belgium
facility: UZ Leuven
city: Hamilton
country: Canada
facility: Hamilton General
state: Ontario
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
city: Dijon
country: France
facility: CHU de Dijon
city: Lille
country: France
facility: CHU de Lille
city: Marseille
country: France
facility: Hôpital Nord Marseille
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Rangueil
city: Berlin
country: Germany
facility: Charité Berlin
city: Bonn
country: Germany
facility: Uniklinik Bonn
city: Freiburg
country: Germany
facility: UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen
city: Hamburg
country: Germany
facility: UKE Hamburg
city: Leipzig
country: Germany
facility: Heart Center Leipzig
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz (University Hospital Mainz)
city: Munich
country: Germany
facility: Ludwig-Maximilian Universität (LMU) Klinikum
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
city: Breda
country: Netherlands
facility: Amphia Hospital (Ziekenhuis) Breda
Study officials:
References: