To investigate in a clinical study how often the use of intravascular optical coherence tomography for femoropopliteal stenotic lesions leads to alterations in treatment planning before and after stent placement, in comparison to traditional digital…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of procedures in which OCT changed the DSA-based treatment
planning before and after stent placement to investigate the impact of OCT
imaging on treatment planning.
Secondary outcome
1. Patient-specific hemodynamics calculated by OCT-based CFD models and
CTA-based CFD models will be compared to investigate the added value of OCT in
the CFD models.
2. Areas with a low wall shear stress calculated by post procedural OCT- and
CTA-based CFD models will be compared to late luminal loss obtained from
patient follow-up to investigate which model performs best.
Background summary
Peripheral arterial disease is a severe clinical problem with an increasing
prevalence due to an ageing population. Endovascular treatment, usually using
stents, is recommended for the femoropopliteal tract. The patency of these
stents is influenced by several factors, including stent sizing and stent
positioning.
Current procedural planning of femoropopliteal disease is primarily based on
single-plane digital subtration angiographies (DSA). This modality provides a
2D image of the vessel lumen, which may be suboptimal for stent sizing and it
may be difficult to choose the optimal stent position as minor lesions may be
missed. Suboptimal treatment could result in unfavourable levels of wall shear
stress causing the vessel wall to be more susceptible to neo-intimal
hyperplasia ultimately causing restenosis and stent failure. Intravascular
optical coherence tomography (OCT) is able to visualize the arterial wall with
a micrometer resolution, which could result in better stent sizing.
Furthermore, OCT is able to visualize different layers in the vessel wall and
identify unhealthy areas, which may lead to a more optimal stent placement as
unhealthy areas can be covered completely. Moreover, OCT provides detailed
patient-specific geometries necessary to develop reliable computational fluid
dynamics (CFD) models that simulate blood flow in stented arteries and
calculate wall shear stresses, which could predict stent patency.
Study objective
To investigate in a clinical study how often the use of intravascular optical
coherence tomography for femoropopliteal stenotic lesions leads to alterations
in treatment planning before and after stent placement, in comparison to
traditional digital subtration angiography based treatment planning.
Study design
Exploratory observational study.
Study burden and risks
The burden of this study consists of two OCT measurements during intervention
and a computed tomography angiography scan during follow-up, which are both not
part of standard clinical care. OCT is standard-of-care in the coronary
arteries and was found to be safe in the superficial femoral artery. In select
cases minor and temporary patient discomfort during saline injection for the
OCT measurement was reported.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
Aged 18 years or older
Written informed consent
Scheduled endovascular treatment of femoropopliteal stenotic lesions with a
Supera or Absolute stent
Clinically and hemodynamically stable
Exclusion criteria
Occluded superficial femoral artery or popliteal artery
Superficial femoral artery and/or popliteal artery diameter larger than 6.5 mm
Severely impaired renal function (eGFR < 30 ml/min), end stage renal disease
Cardiac insufficiency (NYHA 3-4)
Hypersensitivity to iodinated contrast media
BMI > 25 and contralateral approach not possible
Minimal lumen diameter of target lesion < 1.5 mm
Presence of a hemodynamically significant inflow stenosis in the aorto-iliac
tract or the common femoral artery
Participating in another trial with an investigational drug or medical device
concerning the femoropopliteal tract, interfering with the current study
Life expectancy of less than 24 months
Woman of child-bearing age not on active birth control
Legally incapable
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 |
|---|---|
| ClinicalTrials.gov | NCT05057637 |
| CCMO | NL75458.091.20 |