ew duplex criteria for in-stent re-stenosis in aotro iliac arteries. a long term follow up duplex post stenting trial.

• Conditions: atherosclerose; peripheral artery disease; 10003216

• Registration Number: NL-OMON30191
• Lead Sponsor: Ikazia Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

All people who have had an aorto-iliac stent due to claudication intermittens
informed consent

Exclusion Criteria

impossibility to follow up
Persistent pressure loss after stenting

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The patients shall undergo an Ankle-Brachial Index (in rest and after treadmill<br /><br>test) (ABI), DUS and blood analysis.<br /><br>Within a month an angiography (DSA) with pressure measurement (IAPM) shall be<br /><br>performed.<br /><br><br /><br>With duplex ultrasound (DUS) the peak systolic velocity (PSV), in pre, in and<br /><br>post stent area shall be measured. The elevation in blood velocity shall be<br /><br>valued as PSV ratio (in-stent/pre-stent).<br /><br>Within a month an angiography (DSA) with pressure measurement (IAPM) shall be<br /><br>performed. During intra arterial pressure measurement (IAPM), the mean systolic<br /><br>pressure shall be measured in pre, in and post stented area.<br /><br>IAPM is generally known as the *golden standard*.<br /><br>The PSV ratio can be compared with the pressure loss over the stented area and<br /><br>the DSA (stenosis grade).<br /><br>These results can serve as reference values.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Angiographic grade (morphologic view) of stenosis will also be compared with<br /><br>the PSV ratio measured with DUS.<br /><br><br /><br>Ankle-brachial index test (ABI): In rest and after treadmill test. (see chapter<br /><br>6.2)<br /><br>All patients will undergo an ABI in rest and after treadmill test in order to<br /><br>determine the Rutherford classification of peripheral artery disease. This<br /><br>classification is the current standard for categorizing clinical assessment.<br /><br><br /><br>Blood analysis.<br /><br>Blood analysis shall be performed for sub analysis.<br /><br><br /><br>If a second pressure loss is being measured after a PTA or selective stenting<br /><br>and new DUS PSV ratio are being measured. These values, The &Delta; PSV ratio versus<br /><br>the &Delta; pressure loss, shall be calculated and transformated in a x and y axis<br /><br>table. </p><br>