Recruiting NCT04545502
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gelsoft Plus Vascular Graft, Vascular Bypass Graft, Cardiovascular Patch, Gelweave Vascular Graft.
- Who it may be relevant to
- Registry conditions: Aneurysm, Dissection, Aortic Root Aneurysm, Aortic Root Dissection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Canada, France, Germany +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Overview
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.
Interventions
- 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. - 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. - 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. - 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. - 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.
Primary outcome measures
- Operative Death [Time frame: 1 Year]
- Graft Leakage [Time frame: 1 Year]
Secondary outcome measures (3)
- Device Endpoints [Time frame: 1 Year]
- Procedural Endpoints [Time frame: 1 Year]
- Safety Endpoints [Time frame: 1 Year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 10 centers
- University of Colorado Anschutz — Aurora
- University of South Florida - Tampa General — Tampa
- Indiana University Health — Indianapolis
- Duke University — Durham
- East Carolina University — Greenville
- University Hospitals Cleveland Medical Center — Cleveland
- Ohio State University — Columbus
- Lehigh Valley Hospital — Allentown
- … and 2 more centers
France · 8 centers
- CHU Bordeaux — Bordeaux
- CHU Clermont Ferrand — Clermont-Ferrand
- CHU de Dijon — Dijon
- CHU de Lille — Lille
- Hôpital Nord Marseille — Marseille
- CHU de Rennes — Rennes
- Hôpitaux Universitaires de Strasbourg - Hôpital Civil — Strasbourg
- CHU de Toulouse - Hôpital Rangueil — Toulouse
Germany · 7 centers
- Charité Berlin — Berlin
- Uniklinik Bonn — Bonn
- UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen — Freiburg im Breisgau
- UKE Hamburg — Hamburg
- Heart Center Leipzig — Leipzig
- Universitätsmedizin Mainz (University Hospital Mainz) — Mainz
- Ludwig-Maximilian Universität (LMU) Klinikum — Munich
Belgium · 3 centers
- UZ Gent — Ghent
- AZ Groeninge Kortrijk — Kortrijk
- UZ Leuven — Leuven
Canada · 1 center
- Hamilton General — Hamilton
Hungary · 1 center
- Semmelweis University Heart and Vascular Center — Budapest
Netherlands · 1 center
- Amphia Hospital (Ziekenhuis) Breda — Breda
Identifiers
NCT: NCT04545502 · PANTHER-001