The primary objective is validation of the MRA or CTA based personalized pre-procedural computer model, with intra-arterial pressure measurements at rest and during pharmacologically induced hyperemia, which serves as the gold standard.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Not applicable. In vivo measured data is compared with data predicted by a
mathematical model.
Secondary outcome
Not applicable.
Background summary
The current study is a follow-up study of the DETECT-PAD study registered at
www.toetsingonline.nl under number NL 45019.100.13. 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. It was concluded that geometrical and functional (flow)
parameters were the most important for an accurate estimation of the pressure
gradient. The model yielded a total predictive value of 88% for distinguishing
non-hemodynamically significant stenosis (*p<10 mmHg) from hemodynamically
significant stenosis (*p*10 mmHg) as compared to the intra-arterial pressure
measurements (gold standard) [13]. However, the model was only tested using
per-procedural data, i.e. rotational angiography (3DRA). Patients with
non-significant iliac artery stenosis (*p<10 mmHg) were unnecessary exposed to
iodinated contrast and radiation (20% of the included patients). Ideally, the
pressure gradient would already be known before the interventional
procedure.
In the DETECT-PAD study 2.0 the computer model will be validated using
pre-procedural data. As geometrical input is very important, it is imperative
to have sufficient resolution i.e. the Magnetic Resonance Angiography and
Computed Tomography Angiography images should have similar high resolution as
the 3DRA images used in the prior study. The computer model designed and
validated in the earlier DETECT-PAD study will be used in this study.
Therefore, large parts of this study protocol overlap with the protocol of the
earlier conducted DETECT-PAD study.
Study objective
The primary objective is validation of the MRA or CTA based personalized
pre-procedural computer model, with intra-arterial pressure measurements at
rest and during pharmacologically induced hyperemia, which serves as the gold
standard.
Study design
Prospective, observational, multi-center study
Study burden and risks
Patients are treated according to the standard of care. The model prediction
does not have any influence on the treatment of the patient. All devices,
guidewires and catheters used in this study have CE-approval
(1434-MDD-32/2011). Participating patients will undergo a treadmill-test,
ankle-brachial index measurement, duplex ultrasound and a CE-MRA or CTA which
is standard of care. In case the subject undergoes CE-MRA additional MR-flow
measurements will be performed. This prolongs the standard CE-MRA with 15
minutes. No additional contrast agent is needed and therefore there is no
additional risk. In case the study subject undergoes a pre-procedural CTA,
blood velocity will be subtracted from the duplex ultrasound measurement (which
is standard of care). Next, the patients will undergo endovascular treatment
which starts with the acquisition of a rotational angiography (3DRA). The
additional radiation burden as compared to the standard digital subtraction
angiographies is estimated to be <2 mSv, and considered a minimal risk to the
patient*s health. The remainder of the endovascular therapy consists of all
standard of care procedural steps. However, prior to treatment intra-arterial
blood pressure measurements will be performed. To perform these measurements
the pressure monitoring guidewire and fluid filled diagnostic catheter are
positioned proximally and distally from to the lesion, respectively.
Measurements will be performed according to the instructions for use [6 10].
These additional measurements will prolong the intervention with a maximum of
15 minutes and take <5 minutes of extra fluoroscopy time. Intra-arterial
pressure measurements already became an intrinsic part of modern interventional
cardiology [17 18]. No follow-up or extended hospital stay is needed in this
study.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
Age over 18;
Symptomatic, chronic atheroslerotic lesions of the common or external iliac
artery;
One or multiple borderline (50-70%) stenosis measured with ultrasound;
Rutherford class 1-6;
Signed informed consent.
Exclusion criteria
Inability to undergo all measurements;
Mental disability that hinders the ability to understand and comply with
the informed consent;
Pregnancy or breast-feeding;
Renal insufficiency (e-GFR<30 ml/min/1.73m2);
Patients with acute ischemic limbs or aneurismal iliac lesions;
Patients with intimal dissections;
Patients with occlusive inflow (aortic) and/ or occlusions of the target iliac
arteries.
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 |
|---|---|
| CCMO | NL59300.100.16 |
| Other | Trial NL6301 |