The one-dimensional personalized pressure model is able to predict the pressure drop over stenotic lessions in the common and external iliac arteries.
ID
Bron
Verkorte titel
Aandoening
Peripheral Arterial Disease (PAD)
Perifeer arterieel vaatlijden (PAV)
Ondersteuning
Dutch Endovascular Alliance (DEALL)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Doel van het onderzoek
The one-dimensional personalized pressure model is able to predict the pressure drop over stenotic lessions in the common and external iliac arteries.
Onderzoeksopzet
N.A.
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
(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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
(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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4813 |
| NTR-old | NTR5085 |
| Ander register | NL45019.100.13 : Toetsingonline |