No registrations found.
ID
Source
Brief title
Health condition
Peripheral arterial disease of the iliac arteries.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The amount of iodinated contrast agents used
Secondary outcome
-Technical success (yes/no)
-Procedure time (minutes)
-Dose Are Product (mGy*cm^2)
-Registration of complication (free field)
-Total radiation time (minutes, seconds)
-Cost effectiveness
Study objective
The use of additional information provided by 3D fusion road-mapping software will reduce the amount of iodinated contrast agents used compared with endovasculair iliac procedures without 3D fusion road-mapping guidance.
Study design
Data will be obtained from and directly after the intervention
Intervention
Patients are randomized to either the a standard of care PTA procedure or a PTA procedure guided by the 3D fusion road-mapping guidance.
S.G.H Heinen
Nieuwegein
The Netherlands
088-320 1925 (Secretariaat Heelkunde)
s.heinen@antoniusziekenhuis.nl
S.G.H Heinen
Nieuwegein
The Netherlands
088-320 1925 (Secretariaat Heelkunde)
s.heinen@antoniusziekenhuis.nl
Inclusion criteria
- Patient suffering from peripheral arterial disease with a stenosis or occlusion in the iliac arteries who will undergo a PTA procedure
- A diagnostic CE-MRA (<6 months)
- Written informed consent
Exclusion criteria
- Patient under the age of 18
- Patients with acute ischemic limbs
- Patients without written informed consent
- Pregnancy or breast-feeding
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4906 |
| NTR-old | NTR5008 |
| CCMO | NL47680.068.14 |
| OMON | NL-OMON44927 |