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

Aneurysm Clinical Trial

— PANTHER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04545502
• Other study ID #: PANTHER-001
• Status: Recruiting
• Start date: February 17, 2021
• Est. completion date: January 2033

Study information

• Verified date: April 2024
• Source: Vascutek Ltd.
• Contact: Clinical Study Manager
• Phone: +44 141 343 0194
• Email: r.smith1[@]terumoaortic.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2033
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• Cardiovascular Patch
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
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
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.

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Belgium	AZ Groeninge Kortrijk	Kortrijk
Belgium	UZ Leuven	Leuven
Canada	Hamilton General	Hamilton	Ontario
France	CHU Bordeaux	Bordeaux
France	CHU Clermont Ferrand	Clermont-Ferrand
France	CHU de Dijon	Dijon
France	CHU de Lille	Lille
France	Hôpital Nord Marseille	Marseille
France	CHU de Rennes	Rennes
France	Hôpitaux Universitaires de Strasbourg - Hôpital Civil	Strasbourg
France	CHU de Toulouse - Hôpital Rangueil	Toulouse
Germany	Charité Berlin	Berlin
Germany	Uniklinik Bonn	Bonn
Germany	UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen	Freiburg
Germany	UKE Hamburg	Hamburg
Germany	Heart Center Leipzig	Leipzig
Germany	Universitätsmedizin Mainz (University Hospital Mainz)	Mainz
Germany	Ludwig-Maximilian Universität (LMU) Klinikum	Munich
Hungary	Semmelweis University Heart and Vascular Center	Budapest
Netherlands	Amphia Hospital (Ziekenhuis) Breda	Breda
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	University of Colorado Anschutz	Aurora	Colorado
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	East Carolina University	Greenville	North Carolina
United States	Indiana University Health	Indianapolis	Indiana
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of South Florida - Tampa General	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vascutek Ltd.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Hungary,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative Death	30 Day or In-Hospital Mortality	1 Year
Primary	Graft Leakage	Device Failure: The presence of leakage or excessive bleeding through graft/patch	1 Year
Secondary	Device Endpoints	Device failures, requirement for reintervention or device related adverse events	1 Year
Secondary	Procedural Endpoints	Rifampicin or heparin soaking, procedure related adverse events	1 Year
Secondary	Safety Endpoints	Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke	1 Year