Duplex-guided PTA (DuPTA) versus conventional PTA utilizing contrast in peripheral artery disease: Randomised control trial

Recent publications of duplex-guided percutaneous transluminal angioplasty
(PTA) have shown that this relatively new technique is safe and efficacy 1-9.
For the treatment of significant arterial stenosis in patients with symptomatic
peripheral arterial disease. Recent own research, were 45 significant stenoses
were treated in symptomatic patients with stenotic arterial disease have
confirmed these earlier results.
All these studies are descriptive studies of patients with symptomatic
peripheral arterial disease treated by duplex guided PTA. To date, no
randomized controlled studies that conventional PTA with contrast compares with
duplex-guided PTA.

The aim of the research is to demonstrate a possible significant difference in
procedural success and / or clinical success of duplex-guided PTAs compared
with conventional PTA in an RCT.

The study describes the above hypothesis and has led to the creation of the
following study. Preoperative informed consent will be obtained before patients
were randomized into 2 groups. Group 1 will consist of the PTA with
conventional contrast, group 2 is guided to the duplex-PTA. Randomisation will
take place after obtaining informed consent, and patients are needed. For more
information about the radomisatie procedure please refer to section 5.1.4.

This study was designed as a prospective study in which two groups are
randomized. Group 1 will consist of the PTA with conventional contrast, group 2
is guided to the duplex-PTA. Randomisation will take place after obtaining
informed consent. Patients will be assigned a number of follow-up, patient 1,
number 1, etc.

The entire process, pre-and post-operatively will be identical to the current
clinical practice. Patients with an indication for PTA will be discussed in
multidisciplinary consultation, will the local radiologists and vascular
surgeons. If such indication is given, the patient at the clinic will be given
explanations regarding the proposed intervention. If the patient(e) agree to
these proposed intervention, a member of the research team (Drs. TA Sigterman,
Dr. LH Bouwman, Dr. R. Welten, Drs A. Krasznai) will inform the patient about
the above described study. . After explanation, the patient will be given at
least 1 week to consider. After this, Drs. TA Sigterman will contact the
patient to determine whether patient (e) wants to participate in the study. Any
questions will be discussed and answered in a face-to-face conversation, and
informed consent will be signed if patient consent. If patient informed consent
granted, patient will be randomized and for the relevant intervention planned.
If patient does not wish to participate, patient (e) will be regular
intervention. If the patient refrain from participation shall not otherwise
affect his or her treatment and the therapeutic relationship between doctor and
patient.

Of all included patients, the baseline data are listed which are important for
study in a pre-made standard form. Also, in all patients using the standardized
VAS analog pain score will be measured to determine how much pain they have,
this will be done perioperatively and postoperatively on the day after the
procedure are recorded. We also will look at content and restore to
functionality. These will be assessed with a questionnaire.
The follow-up will be carried out by the members of the research (Drs. TA
Sigterman, Dr. LH Bouwman, Dr. R. Welten, Drs A. Krasznai). Patients will be
seen 4 weeks postoperatively at routine control clinical follow-up, whereby
they can indicate the degree of satisfaction of the VAS pain score. Routine
duplex examination of the treated lesion will for outpatient visits are made.
In addition, the time required to return to work and restoration of the
functionality can be viewed. Patients participating in the study will be no
additional examinations. This means, no additional laboratory tests and no
additional studies.

Procedure contrast PTA
Conventional PTA is not different from current clinical course. Patients report
sober in the morning, the day of the planned intervention included the (Day
Care / Fasting recording unit) (Ward 1West). Where they are prepared, according
to local protocol here they receive any necessary medication (Protocol
preoperative administrative actions / Fasting admissions, day care, sober
recording unit). After which they will undergo the PTA procedure in the angio
suite. This procedure will be performed by an interventional radiologist (R.
Heijboer, L. Leeuw) or vascular surgeon (LH Bouwman, A. Krasznai, R. Welten).
After the procedure, patients are brought to ward 11-12 (Protocol Angio Room
transfer after PTA to nursing). Here there will be frequent checks are carried
out in the Ward 11/12, according to local protocol (Protocol Angiography
aftercare PTA and intervention). 1 day postoperatively, each patient will
undergo a routine duplex examination of the treated lesion (angioplasty
stenosis), to determine the Peak Systolic Velocity (PSV). This research will be
conducted on the KNF. There will be no specific employees be designated for
these studies to be performed blinded. On the application will only be listed
PTA, so that the vascular technicians of the KNF are not aware of which
treatment the patients have undergone . If the patient recovers adequate
he/she will be discharged the same day, if the ward doctor deems this
possible. This is not different from current clinical course.


Procedure Duplex PTA
Duplex-guided PTA is not different from current clinical course. Patients
report sober in the morning, the day of the planned intervention on the (Day
Care / Fasting recording unit) (Ward 1West). Where they are prepared, according
to local protocol here they receive any necessary medication (Protocol:
preoperative administrative actions / Fasting admissions, day care, sober
recording unit). After which they will undergo the PTA, the operating procedure
will take place under spinal anesthesia. This anesthesia is administered by the
attending anesthesiologist. The PTA procedure will be performed by vascular
surgeons (A. Krasznai, LH Bouwman), in collaboration with two vascular
technicians of clinical neurophysiological function lab (KNF). These two
employees will assist in visualizing the arterial stenotic lesions with duplex.
After the intervention, all patients will be monitored at the recovery until
the attending anesthesiologist approves the transfer of the patient (e) to the
regular section (Ward 11-12) (Protocol: Dismissal Criteria Recovery). The
department will frequent checks take place according to local protocol (see
Annex protocol PTA Atrium MC Heerlen). 1 day postoperatively, each patient will
undergo a routine duplex examination of the treated lesion (angioplasty
stenosis), to determine the Peak Systolic Velocity (PSV). This research will be
conducted on the KNF (floor 3). There will be no specific employees be
designated for these studies to be performed blinded. On the application will
only be listed PTA, so that the vascular technicians of the KNF are not aware
of which treatment have undergone patients. If the patient recovers adequate
he/she will be discharged the same day, if the ward doctor deems this
possible. This is not different from current clinical course.

The entire process, pre-and post-operatively will be identical to the current
clinical practice.
Patients will be discussed in the multidisciplinary consultation with a local
indication, the interventional radiologists (Drs. R. Watson, Drs. L. Lion) and
vascular surgeons (Dr. LH Bouwman, Dr. R. Welten, Drs A. Krasznai) the
indication for angioplasty standard set stenotic lesions. If this indication is
given, the patient will get the police explanation of the proposed
intervention. If patient (e) agree to the proposed intervention will be a
member of the research group (Drs. TA Sigterman, Dr. LH Bouwman, Dr. R. Welten,
Drs A. Krasznai) patients on the above research in an interview at the
outpatient clinic . After explaining the patient's patient with us and at least
one week to think. After this week to think will Drs. TA Sigterman patient
contact by telephone to determine whether patient (e) to participate in the
study. Any questions will be discussed and answered in a face to face
conversation, after which it will be if patient gives consent. Signed informed
consent If patient informed consent granted, and will be scheduled for that
intervention. Patient randomized If patient does not wish to participate will
be patient (e) regular scheduled. If the patient refrain from participation has
no effect on his or her treatment and the therapeutic relationship between
doctor and patient.

Of all patients included, the baseline data are recorded that are important for
study in a pre-made standard form (see Appendix). Will also be in all patients
using the standardized VAS analog pain score determines how much pain they
have, this will perioperative and postoperative be registered on the day after
surgery (see Annex). Will also be looked at satisfaction and restore
functionality. These will be assessed with a questionnaire (see Appendix).
The follow-up will be performed by members of the research group (Drs. TA
Sigterman, Dr. LH Bouwman, Dr. R. Welten, Drs A. Krasznai). Patients will come
in weeks postoperatively routine, which they can indicate in the VAS pain
score. Satisfaction levels Routine duplex examination of the treated lesion
will be made two weeks after the intervention. For outpatient visit Also, the
length of time to return to work and restoration of the functionality to be
viewed. Patients participating in the study will not undergo additional tests.
Here it is intended, no additional laboratory tests and no additional studies.
See Appendix schedule described above scores.

This study does not burden the participants. Given that the two treatment
options do not differ from current practice, we expect that patients experience
no additional burden through participation in the study. There is no additional
outpatient visits, investigations or interventions.