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blood flow visualisation in the abdomen for patients with vascular disease


- candidate number28503
- NTR NumberNTR6980
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jan-2018
- Secondary IDs2017-3694 NL63077.091.17
- Public Titleblood flow visualisation in the abdomen for patients with vascular disease
- Scientific TitleFlow quantification using ultrasound particle image velocimetry in patients with aortoiliac occlusive disease
- ACRONYMechoPIV in AIOD
- hypothesis2-dimensional visualisation of blood flow around the aortic bifurcation in patients with Aortoiliac Occlusive Disease (AIOD) can predict disease progression and the success of endovascular treatment.
- Healt Condition(s) or Problem(s) studiedAtherosclerose, Aortoiliac Occlusive Disease, Necrosis, Peripheral Arterial Disease, Vascular disease
- Inclusion criteriaGroup A:
- Recently diagnosed untreated aortoiliac stenotic lesion, confirmed with Duplex US (>50%)
- Presence of claudication symptoms, but no pain at rest (Fontaine 2a / 2b)
- Exercise therapy prescribed

Group B:
- Planned endovascular treatment of an iliac stenotic lesion through placement of a single stent.

Group C:
- Schedul ed endovascular treatment of extensive aortoiliac lesion with a CERAB configuration.
- Exclusion criteria- Hypersensitivity to the active substance(s) or any of the excipients in SonoVue
- Right-to-left cardiac shunt
- Severe pulmonary hyperte nsion (pulmonary artery pressure > 90mmHg)
- Uncontrolled systemic hypertension
- Severe pulmonary disease (e.g. COP D GOLD 3/4, adult respiratory distress syndrome)
- Clinically unstable cardiac disease (recent or ongoing myorcardial infarction, unstable a ngina at rest, clinically worsening cardiac symptoms, severe cardiac arrythmia’s, etc.)
- Loss of renal function (GFR < 45 ml/min)
- Congestive heart failure (class III or IV)
- Hypersensitivity to iodinated contrast m edia
- Age < 50 (group A)
- Pregnancy
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2018
- planned closingdate1-mrt-2023
- Target number of participants130
- Interventionsnone
- Primary outcomegroup A: Lesion severity (duplex)

Group B & C: Primary patency
- Secondary outcomeGroup A: Walking distance, Ankle-Brachial-Index

Mortality, Quality of life
- Timepoints2 months, 6 months, 1 year, 2 years, 5 years
- Trial web siten.a.
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc Stefan Engelhard
- CONTACT for SCIENTIFIC QUERIESMSc Stefan Engelhard
- Sponsor/Initiator Rijnstate Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
"Lijf & Leven" foundation
- Publications-
- Brief summaryRationale: Visualization of local blood flow patterns in the aortoiliac tract is challenging, but clinically relevant as specific flow perturbations could affect atherosclerotic disease progression and stent patency.

Objective: To identify local flow patterns that can predict disease progression and failure of stent patency in patients with untreated and treated atherosclerotic lesions in the aortoiliac tract.

Study design: Prospective cohort study. Subjects will receive ultrasound particle image velocimetry (echoPIV) measurements at baseline to obtain blood flow velocity data and to calculate flow derived parameters. 5 year follow-up of subjects will be performed to measure clinical outcome parameters and the influence of the calculated flow parameters on these outcome parameters will be investigated.

Study population: The study population consists of three different patient groups. Group A: patients with a recently diagnosed stenotic lesion in the iliac arteries, with intermittent claudication, that are treated with exercise therapy. Group B: patients that receive endovascular treatment (single stent placement) of an isolated iliac stenotic lesion. Group C: patients that receive endovascular treatment of extensive aortoiliac stenotic lesions with covered endovascular reconstruction of the aortic bifurcation (CERAB) for aortoiliac occlusive disease.

Main study parameters/endpoints: The main predictor variables of this study are flow derived parameters, such as: mean wall shear stress (WSS), oscillatory shear index (OSI), recirculation and blood stasis. Clinical outcome parameters are: lesion severity (duplex US), walking distance and ankle-brachial-index (ABI) in group A and primary stent patency in group B and C.
- Main changes (audit trail)
- RECORD29-jan-2018 - 2-feb-2018


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