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The Frontier Study for Endovascular Aneurysm Repair
Patient
Information Sheet For patients with
abdominal aortic aneurysms unsuitable for conventional open repair or for
inclusion in the National EVAR trials because they are medically unfit. You are being invited to
take part in a research study, it is a study based at the Queen’s Medical
Centre in Nottingham. Before you decide if you wish to be involved, it is
important for you to understand why the research is being done and what it will
entail. Please take time to read the following information carefully and discuss
it with your relatives, friends, and your G.P. if you wish. Ask us if there is
anything that is not clear or if you would like more information. Take time to
decide whether or not you wish to have the proposed operation. I.
Study Title: Frontier Study for Endovascular Aneurysm Repair This study is for patients who have been found to be
unsuitable for the conventional open aneurysm repair or for those where the
manufacturers of the EVAR grafts do not recommend their use. The following
explains the study: II
What is an abdominal aortic aneurysm (AAA) ? The abdominal aorta is the main artery that transports blood
pumped from your heart to all the parts of your body below the rib cage. For
example, blood travels from the abdominal aorta to your kidneys intestines and
legs. You have a condition known as an abdominal aortic aneurysm,
where part of the aorta has swollen like a balloon and is now large enough for
your Doctor to think it may rupture. If it did so, it would be fatal without an
emergency operation which in itself is dangerous. III
How are abdominal aortic aneurysms treated? People who have an AAA have in the past had their condition
treated by an operation when a large cut is made in their tummy (Conventional
aneurysm repair). For this operation a person has to be fit enough. There are
risks involved and even people who are fit can die. Recently, a new method for
fixing an AAA has been developed when cuts are made in the groin. People recover
from this operation quickly and it may be better than the conventional repair.
As Surgeons, we do not know if this new technique called EVAR is better so there
is a national trial currently being done. To do an EVAR repair, it is necessary
for the aneurysm to be of a certain shape or size so that the devices available
can fit. You are not thought to be fit enough to have the conventional
operation. Investigations have shown that the shape of your aneurysm is such
that we cannot use one of the commercially available grafts to strengthen the
aorta from inside. It is possible however to use a custom made device and
different methods to try and treat your aneurysm. All of these are unproven and
in some cases can carry a risk of you requiring further surgery, or even making
the situation worse. If you agree to take part in this study, we will us a
method that introduces a strengthening polyester tube (graft) with a metal frame
(stent) through an artery in the groin performed whilst you are either asleep or
awake but anaesthetised from the waist down. The graft is released to lie within
the aneurysm near your navel, and the intention is to send the blood through
this so that it does not touch the walls of the aortic aneurysm.
Having considered your general condition, we feel on balance
that it would be better for us to concentrate on improving your general
condition medically, rather than selecting the more conventional open operation
for abdominal aortic aneurysm. This would require a large operation to cut
through your abdominal wall to get at the swelling deep inside you beneath your
navel. We suggest that you receive from us our best medical advice
of how to manage your general state, particularly your blood pressure and if you
smoke, your smoking. We have shown that inhalation of tobacco fumes hastens the
swelling of an abdominal aortic aneurysm and increases the risk of aneurysm
rupture, thus if we can persuade our patients not to smoke, the aorta may well
swell less rapidly. Blood pressure is another important factor and if our
patients have a very carefully controlled blood pressure, we believe that this
will be extremely good for them over a period of time. The question we are uncertain about is whether or not in the
future we should treat your aorta with this new stent graft system or rely on
medical treatment and avoid any operation. We simply do not know whether it is
an advantage over and beyond the best medical treatment that is available to
you. If the new stent graft method
did not work perfectly, this could precipitate the need for an operation to
rectify the problem. As you know we are extremely reluctant to recommend the
full open operation for you. There would be a great risk to your life if we did
an open operation. IV
What is the purpose of the study? The purpose of the study is to see if this experimental
procedure would help people like you who are not fit for the conventional
operation. V
Why have I been chosen? You have been sent to us by your Doctor for treatment.
Without treatment, there is a risk that your aneurysm will burst and cause your
death. After much discussion between the surgeons, radiologists, and
anaesthetist involved in your case, we feel that the risk to your life if you
have an endovascular repair of your aneurysm is mild
/ moderate / severe,
in addition we feel that the chances of the device working are very
good / good / poor.
In addition it is unlikely /
likely / very likely
.that you will need to have further surgical procedures done in the future to
correct problems with the device. VI
Do I have to take part? It is up to you to decide whether or not you wish to have an
endovascular aneurysm repair. If you do decide to take part, you will be given
this information sheet to keep and be asked to sign a consent form. If you
decide to take part you are free to withdraw at any time and without giving any
reason. This will not affect the standard of care you receive. VII
What will happen to me if I take part? As your doctor is uncertain as to the outcome of using this
new technique, they will discuss with you all the risks that are thought to be
involved. In Nottingham, we have treated over 300 patients with this technique
and your doctor will be able to discuss with you what has happened to those
patients. The reason we need to include you in this Frontier Study is that we
think we may be able to treat your aneurysm, but are not sure. If you choose not
to be treated than you will get the best current medical treatment. You will
need regular checks on your blood pressure and if you smoke we hope to convince
you to stop as we have shown this aneurysm grows more slowly in the absence of
smoke inhalation. If you decide to
have the operation, we will ask you questions about your quality of life and
would like to see you about three times in the year following the entry to the
trial, and then once every year. Each visit will not take long, you will have a
CT scan performed to check your aorta and you will always be asked some
questions about how you feel. VIII
What do I have do? You do not need to do anything and there should not be any
restrictions to your lifestyle. IX
What are the alternatives of treatment? If you do not wish to take part in this frontier study, it is
not recommended that you have your aneurysm repaired using the more conventional
operation or as part of the EVAR study. Your doctors will provide the best
medical treatment they can. X
What are the possible disadvantages and risks of taking part? If you have the endovascular aneurysm repair, the graft may
not be fixed in place as securely as the more invasive open repair. There is a
chance that the stents holding the tube in place may loosen and need correction.
If they cannot be corrected, you may need to have a conversion operation, which
would replace the graft with another one using the conventional open repair
method. As you know this open operation carries a high risk to your life. In
addition, the aneurysm may still grow and burst because of a condition called
endoleak. XI
What are the possible benefits of taking part? It is necessary for us to know if we should be offering this
new technique to patients like you, in addition to the medical treatment. We
need to know, so that we can treat all of our patients in the best way. XII
What if new information becomes available? Sometimes during the course of a research project, new
information becomes available about the treatment being studied. If this
happens, your doctors will tell you about it and we would expect to introduce
new therapies, medical and surgical as developments occur.
During this study we have arranged for data monitoring and an Ethics
Committee to audit the data at regular intervals to see that the study is
progressing well and the problems that would put you at unnecessary risk. XIII
What happens when the research study stops? When the study comes to an end the data will be analysed. We
may then know if there is an advantage to treating patients with this new stent
graft technique who would not be suitable for the other methods available. At
the moment we do not know if this will happen. XIV
What if something goes wrong? If taking part in this project harms you there are no special
compensation arrangements. If you are harmed due to someone’s negligence, then
you may have grounds for a legal action, but you may have to pay for it,
regardless of this if you wish to complain about any aspect about the way you
have been approached or treated during the course of this study, the normal
National Health Service complaints mechanisms may be available to you. XV
Will my taking part in this study be kept confidential? All information that is collected about you during the course
of the research will be kept strictly confidential. Any information that leaves
the hospital will have your name and address removed so that you cannot be
recognised from it. XVI
What will happen to the results of this research study? The results of this study will be constantly reviewed but
there will also be an analysis of the results in two years’ time. The analysis
will take some time and may not be published for two or three years. If you are
interested in receiving a copy of the results we will be happy to let you know
which medical journal has published the outcome. The published report will not
identify any individual who participated in the study.
XVII
Who is organising and funding the research? The
National Health Service is always keen to improve the health of the general
public. We are funded in part by the Queen’s Medical Centre but also by one of
the companies who manufacture the endovascular graft that you will be receiving.
XVIII
Who has reviewed the study? The Research and Ethics Committee of Queen’s Medical Centre
have reviewed this study. This body assesses the methods and procedures of this
study and advised us on how to write this information sheet. We will keep in
close communication with the Hospital Ethics Committee. Contact for further
information or if you have any further queries you can contact the study
co-ordinator. Please ring the Vascular Studies Unit on 01159249924 ext 42912 .
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