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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30191
Enrollment
140
Registered
2006-06-15
Start date
2006-06-30
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

atherosclerose peripheral artery disease

Interventions

None listed

Sponsors

Ikazia Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: impossibility to follow up Persistent pressure loss after stenting

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)