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Validation of a patient-specific computer model, based on already avialable images, to determine severity of groin artery stenoses.

Recruiting
Conditions
Peripheral arterial disease (PAD), Peripheral arterial occlussive disease (PAOD), Perifeer vaatlijden, etalage benen
Registration Number
NL-OMON27119
Lead Sponsor
St. Antonius Hospital Nieuwegein
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

I.Age over 18;

II.Symptomatic, chronic atheroslcerotic lesions of the common or externa iliac artery;

Exclusion Criteria

I.Mental disability that hinders the ability to understand and comply with the informed consent;

II.Pregnancy or breast-feeding;

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
validation of the MRA or CTA based personalized pre-procedural computer model, with intra-arterial pressure measurements at rest and during pharmacologically induced hyperemia as a reference
Secondary Outcome Measures
NameTimeMethod
I. To compare the geometrical information obtained from CTA and MRA with 3D rotational angiography<br /><br>II To quantify the extra radiation, procedure time needed and costs made to determine the hemodynamic significance of iliac artery stenosis by means of invasive pressure measurements as compared to controlled match patient population.
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