search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Validation of a patient-specific computer model, based on already avialable images, to determine severity of groin artery stenoses.


- candidate number26852
- NTR NumberNTR6476
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mrt-2017
- Secondary IDs59300.100.16 as registered on www.toetsingonline.nl
- Public TitleValidation of a patient-specific computer model, based on already avialable images, to determine severity of groin artery stenoses.
- Scientific TitleIn-vivo validation of a non-invasive, magnatic resonance or computed tomography based patient-specific pressure model to determine the severity of common and external iliac artery obstructions, and the need for revascularization
- ACRONYMDETECT-PAD study 2.0
- hypothesis
- Healt Condition(s) or Problem(s) studiedPeripheral Arterial Disease, Limb ischemia, Intermittent claudication
- Inclusion criteriaI. 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
- Exclusion criteriaI. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jul-2017
- planned closingdate1-jan-2019
- Target number of participants50
- InterventionsStandard of care endovascular interventions (if applicable)
- Primary outcomevalidation 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
- Secondary outcomeI. To compare the geometrical information obtained from CTA and MRA with 3D rotational angiography
II To quantify the extra radiation, procedure time needed and costs made to determine the hemodynamic significance of iliac artery stenosis by means of invasive pressure measurements as compared to controlled match patient population.
- Timepoints-
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S.G.H Heinen
- CONTACT for SCIENTIFIC QUERIES S.G.H Heinen
- Sponsor/Initiator Sint Antonius Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
St. Antonius Research Fund
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD9-mrt-2017 - 9-sep-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl