ID
Bron
Verkorte titel
Aandoening
Peripheral arterial disease (PAD), Peripheral arterial occlussive disease (PAOD), Perifeer vaatlijden, etalage benen
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
validation of the MRA or CTA based personalized pre-procedural computer model, with intra-arterial pressure measurements at rest and during pharmacologically induced hyperemia as a reference
Achtergrond van het onderzoek
The DETECT-PAD study 2.0 is a follow-up study of the DETECT-PAD study. The DETECT-PAD study was a pilot study with the objective to quantify the hemodynamic significance of borderline iliac artery stenosis based on an invasive imaging technique. The developed computer model was validated by comparing the predicted pressure gradient with the measured intra-arterial pressure gradient. Also, the influence of the input parameters on the predicted pressure gradient was investigated.
In the ealier study, the model was only tested using angiography data. In DETECT-PAD study 2.0 the computer model will be validated using pre-procedural data (i.e. computed tomography angiography or magnetic resonance angiography). The computer model designed and validated in the earlier DETECT-PAD study will be used in this study.
Onderzoeksopzet
-
Onderzoeksproduct en/of interventie
Standard of care endovascular interventions (if applicable)
Publiek
S.G.H Heinen
Nieuwegein
The Netherlands
088-320 1925 (Secretariaat Heelkunde)
s.heinen@antoniusziekenhuis.nl
Wetenschappelijk
S.G.H Heinen
Nieuwegein
The Netherlands
088-320 1925 (Secretariaat Heelkunde)
s.heinen@antoniusziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
I. Age over 18;
II. Symptomatic, chronic atheroslcerotic lesions of the common or externa iliac artery;
III. Single or multiple borderline (50-70%) stenosis measured with ultrasound
IV. Rutherford class 1-6
V. Signed informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
I. Mental disability that hinders the ability to understand and comply with the informed consent;
II. Pregnancy or breast-feeding;
III. Renal insufficiency (e-GFR<30 ml/min/1.73m2);
IV. Patients with acute ischemic limbs or aneurismal iliac lesions;
V. Patients with intimal dissections;
VI. Patients with a combination of low blood pressure (RR) and high heart rate (HR) that might be at risk when inducing pharmacological hyperemia.
VII. Patients with occlusive inflow (aortic) and/ or occlusions of the target iliac arteries.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6301 |
| NTR-old | NTR6476 |
| Ander register | as registered on www.toetsingonline.nl : 59300.100.16 |