In-vivo validation of non-invasive, magnetic resonance or computed tomography based patient-specific pressure model to determine the severity of common and external iliac artery obstructions, and the need for revascularization non-invasively.

Recruiting

• Conditions: Intermittent claudication; peripheral arterial disease; 10003216

• Registration Number: NL-OMON49149
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Age over 18;
Symptomatic, chronic atheroslerotic lesions of the common or external iliac
artery;
One or multiple borderline (50-70%) stenosis measured with ultrasound;
Rutherford class 1-6;
Signed informed consent.

Exclusion Criteria

Inability to undergo all measurements;
Mental disability that hinders the ability to understand and comply with
the informed consent;
Pregnancy or breast-feeding;
Renal insufficiency (e-GFR<30 ml/min/1.73m2);
Patients with acute ischemic limbs or aneurismal iliac lesions;
Patients with intimal dissections;
Patients with occlusive inflow (aortic) and/ or occlusions of the target iliac
arteries.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Not applicable. In vivo measured data is compared with data predicted by a<br /><br>mathematical model. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>