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

In-vivo validiation of a non-invasive, magnetic resonance-based patient-specific pressure model to determine the severity of common and external iliac artery obstructions, and the need for revascularization

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
NL-OMON
Registry ID
NL-OMON22159
Enrollment
30
Registered
2015-03-09
Start date
2014-01-16
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Peripheral Arterial Disease (PAD) Perifeer arterieel vaatlijden (PAV)

Interventions

Standard of care percutaneous transluminal angioplasty (PTA) procedures with additional intravascular ultrasound (IVUS) and in-vivo pressure gradient measurements performed in one of the common and ex

Sponsors

St. Antonius Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (1) Age over 18; (2) Symptomatic, chronic atheroslerotic lesions of the common iliac artery or external iliac artery; (3) Single or multiple borderline (50-70%) stenosis measured with ultrasound; (4) Rutherfordclass 1-6; (5) Signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Previous endovascular or surgical treatment of the target iliac arteries; (2) Inability to undergo all measurements (e.g. usual MRI contra-indications); (3) Mental disability that hinders the ability to understand and comply with the informed consent; (4) Pregnancy or breast-feeding; (5) Renal insufficiency (e-GFR<30 ml/min/1.73m2); (6) Known allergy to gadolinium based contrast agents; (7) Patients with acute ischemic limbs or aneurismal iliac lesions; (8) Patients with occlusive inflow (aortic) and/ or outflow (common femoral artery) disease.

Design outcomes

Primary

MeasureTime frame
Validation of the personalized pressure model with intra-arterial pressure and flow measurements (model validation), and intravascular ultrasound (model input validation) that serves as the gold standard.—

Secondary

MeasureTime frame
Validation of the by the model predicted increase of blood pressure after successful intervention of the stenosis Comparing the diameter estimated by conventional pre-procedural measurements techniques {i.e. visual inspection (”eye-balling”), Contrast Enhanced Magnetic Resonance Angiography (CE-MRA), High Spatial Resolution Magnetic Resonance Imaging (HR-MRI), standard angiography and angiography images analyzed by 3 dimensional Quantitative Vascular Analysis (QVA 3D) software (Pie Medical Imaging, Maastricht, The Netherlands) } with the gold standard (IVUS).—

Contacts

Public ContactStefan G.H. Heinen
s.heinen@antoniusziekenhuis.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)