Fluoroscopy with MRA fusion image guidance in endovascular iliac artery intervention

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21907

Enrollment

106

Registered

2014-12-16

Start date

2015-10-08

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial disease of the iliac arteries.

Interventions

Patients are randomized to either the a standard of care PTA procedure or a PTA procedure guided by the 3D fusion road-mapping guidance.

Eligibility

Inclusion criteria

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

Exclusion criteria: - Patient under the age of 18 - Patients with acute ischemic limbs - Patients without written informed consent - Pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
The amount of iodinated contrast agents used	—

Secondary

Measure	Time frame
-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	—

Contacts

Public ContactS.G.H Heinen

St. Antonius Ziekenhuis (Vaatchirurgie)

s.heinen@antoniusziekenhuis.nl088-320 1925 (Secretariaat Heelkunde)

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)