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Fluoroscopy with MRA fusion image guidance in endovascular iliac artery intervention


- candidate number21165
- NTR NumberNTR5008
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-dec-2014
- Secondary IDsNL47680.068.14 Toetsing online
- Public TitleFluoroscopy with MRA fusion image guidance in endovascular iliac artery intervention
- Scientific TitleFluoroscopy with MRA fusion image guidance in endovascular iliac artery intervention
- ACRONYM3DMR-ILIAC-ROADMAPPING
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedPeripheral arterial disease (PAD)
- 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
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blinding[default]
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 8-okt-2015
- planned closingdate
- Target number of participants106
- InterventionsPatients are randomized to either the a standard of care PTA procedure or a PTA procedure guided by the 3D fusion road-mapping guidance.
- Primary outcomeThe 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
- TimepointsData will be obtained from and directly after the intervention
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES S.G.H Heinen
- CONTACT for SCIENTIFIC QUERIES S.G.H Heinen
- Sponsor/Initiator St. Antonius Hospital, Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD16-dec-2014 - 28-okt-2015


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