The objective of this prospectieve comparing multicenter study is to analyze the possible benifits on iodinated contrast, fluoroscopy time and irradiation dose by using the 3D fusion roadmap in iliac endovascular interventions .
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The amount of iodinated contrast agent used during the procedure (ml)
Secondary outcome
- Total fluoroscopy time (in minutes en seconds)
- Total procedure time (in minutes)
- Total radiation exposure i.e. Dose area product (mGy*cm^2)
- Technical success of the procedure (Yes versus No).
- Registration of possible complications (Free text).
- Costeffectiveness of the fusion navigation software
Background summary
Fusion navigation is a new technique used during endovascular interventions .
Both, the Acadmisch Hospital Maastricht ( AZM ) and the St. Antonius Hospital
in Nieuwegein have the required state of the art equipment and software
available to perform those fusion guided interventions which are already used
in practice. From several publications it is known that the use of 3D fusion
roadmapping leads to a significant reduction used during endovascular
procedure. Since 2012 the AZM is performing studies on the feasibility of the
3D fusion roadmap when treating complex aneurysms (METC number 12-4-125 ) . 3D
fusion roadmapping for peripheral vessels such as the iliac vessels has not
been randomized investigated.
To investigate the potentiel benefits of the fusion 3D roadmap, this randomized
multi-center study initiated which will compare iliac endovascular
interventions with and without fusion 3D roadmap guidance. The group without
the 3D fusion roadmap is treated the conventional way with fluoroscopy imaging.
In the group with the 3D fusion roadmap, the earlier diagnostic MRA of the
pelvic and leg arteries is linked to the fluoroscopy images made during the
procedure. The obtained 3D fusion roadmap is available next to the normal
fluoroscopy images.
The data related to iodinated contrast agent used, irradiation dose (Dose Area
Product), fluoroscopy time , total procedure time, and technical success is
standardized, collected and both groups are compared with each other. Possible
complications will be registered . Patients are asked to fill out an informed
consent.
Study objective
The objective of this prospectieve comparing multicenter study is to analyze
the possible benifits on iodinated contrast, fluoroscopy time and irradiation
dose by using the 3D fusion roadmap in iliac endovascular interventions .
Study design
This studie is a prospective randomized comparing multi-center studie. All
patients that meet the inclusion criteria may be asked to participate in our
study. After filling out informed consent, patients will be randomized in the
group with or without 3D fusion roadmap technique. The group without 3D fusion
roadmap undergoes the conventional treatment with fluoroscopy imaging, as is
the standard of care method. Next to conventional imaging, when performing the
intervention in th group with the 3D fusion roadmapping additional imaging is
used. Theretofore, before starting the endovascular procedure patients undergo
a contrast-free CBCT which is linked to the diagnostic MRA. The created MRA
fusion roadmap is used during the procedure and gives additional information.
Intervention
All included patients will be randomized into 2 groups. The first group is
treated conform the standard of care PTA procedures. The other group undergoes
a PTA procedure with guidance of the 3D MR fusion roadmap.
Study burden and risks
It is known from resent publications that the use of 3D fusion roadmapping
during iliac endovasculair procedures leads to a significant reduction of the
amount of iodinated contrast used. The extra dose due to CBCT is comparable
with 1.5 times the annual background dose in the Netherlands. The health risk
related to the dose obtained can be categorized as very low.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
* All Patients which are suffering from Peripheral Arterial Disease (PAD) and need endovascular treatement of the iliac arteries.
* An MRA examination, no older than six months and artefact free.
* Signed informed consent
Exclusion criteria
* Patients under 18.
* Mental disability that hinders the ability to understand and comply with the informed consent.
* Patients who need acute treatment
* Pregnancy or breast-feeding
* Patients without MRA because of contra-indications suchs as claustrophobia, pacemaker or gadolinium allergy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL47680.068.14 |
| OMON | NL-OMON21907 |