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)


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.


- candidate number21775
- NTR NumberNTR5085
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mrt-2015
- Secondary IDsToetsingonline NL45019.100.13
- Public TitleIn-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.
- Scientific TitleIn-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
- ACRONYMDETECT-PAD study
- hypothesisThe one-dimensional personalized pressure model is able to predict the pressure drop over stenotic lessions in the common and external iliac arteries.
- Healt Condition(s) or Problem(s) studiedPeripheral Arterial Disease
- 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 16-jan-2014
- planned closingdate4-apr-2017
- Target number of participants30
- InterventionsStandard 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.
- Primary outcomeValidation 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 outcomeValidation 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).
- TimepointsN.A.
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESir. Stefan G.H. Heinen
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator St. Antonius Hospital
- Funding
(Source(s) of Monetary or Material Support)
Volcano Corporation, Dutch Endovascular Alliance (DEALL)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD9-mrt-2015 - 9-jul-2017


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