No registrations found.
ID
Source
Brief title
Health condition
Peripheral Arterial Disease (PAD)
Perifeer arterieel vaatlijden (PAV)
Sponsors and support
Dutch Endovascular Alliance (DEALL)
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Study objective
The one-dimensional personalized pressure model is able to predict the pressure drop over stenotic lessions in the common and external iliac arteries.
Study design
N.A.
Intervention
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 external iliac arteries.
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
(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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4813 |
| NTR-old | NTR5085 |
| Other | NL45019.100.13 : Toetsingonline |