The main objective of the current study is to determine the feasibility of spatial and temporal quantification of swirling blood flow inside the SFA of patients treated with the BioMimics 3D stent, using high framerate (HFR) contrast enhanced…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Vector velocity fields derived from echoPIV data will be used to calculate and
visualize spatiotemporal blood flow velocity profiles. Offline analysis will be
used to investigate the existence of swirling flow patterns.
Secondary outcome
Secundary study parameters are as follows:
- The spatiotemporal swirling blood flow patterns obtained with echoPIV with
the patient in supine position and in sitting position will be compared to
investigate the influence of the patients* position on swirling blood flow
patterns.
- CTA images from the patients* upper leg will be used to assess the geometry
of the treated vessel and its link to echoPIV outcomes in terms of swirling
flow.
- Velocity estimates obtained with conventional Doppler ultrasound will be
compared to echoPIV outcomes.
- Flow related parameters, indicating the presence of swirling flow, will be
calculated.
Background summary
Peripheral arterial disease (PAD) of the lower extremity is the third leading
cause of atherosclerotic cardiovascular morbidity. Endovascular
revascularization has become the principal treatment strategy in most
femoro-popliteal lesions. Veryan has developed a stent graft (BioMimics 3D
stent) for the superficial femoral artery (SFA) that focuses on mimicking the
native vessel geometry, which has a helical or non-planar shape. The helical
shape could promote swirling flow, which in turn can creates high, protective,
values of wall shear stress (WSS), increasing the treatment durability. The
application of stents that promote helical anatomy is still novel and not yet
common clinical practice. In-vitro studies with the BioMimics stent have been
performed as well as clinical studies. However, fundamental in-vivo knowledge
on the presence and most optimal shape of swirling flow induced by helical
stents is lacking.
Study objective
The main objective of the current study is to determine the feasibility of
spatial and temporal quantification of swirling blood flow inside the SFA of
patients treated with the BioMimics 3D stent, using high framerate (HFR)
contrast enhanced ultrasound (CEUS) and particle image velocimetry (PIV), in
short echoPIV.
Secondary objectives are:
- To evaluate the influence of the position of the patient on the induced
swirling flow patterns in the BioMimics 3D stent.
- To investigate the change in geometry of the patients* vessels after
treatment with the BioMimics 3D stent based on CT angiography (CTA) scans.
- To compare the blood flow velocity outcomes obtained with echoPIV to outcomes
of conventional Doppler measurements.
- To calculate flow derived parameters related to swirling flow.
Study design
Feasibility study.
Study burden and risks
The burden of this study consists of the possibility of 1 extra visit to the
hospital. This visit includes the echoPIV measurements that are performed with
a US machine that is not yet approved for clinical use. This machine has been
thoroughly tested, used in various other clinical studies at Rijnstate, and is
judged to be safe for use in humans. Also, an approved ultrasound contrast
agent (UCA) is injected through a venous cannula during the echoPIV
measurements. There is a very small risk of adverse events associated with the
use of this UCA. Appropriate safety measures have been taken to account for
this. Finally, a CT angiography scan is performed that is not part of standard
care.
Drienerlolaan 5
Enschede 7522NB
NL
Drienerlolaan 5
Enschede 7522NB
NL
Listed location countries
Age
Inclusion criteria
- Male or female > 18 years of age
- Stenotic lesion in the SFA treated with a BioMimic 3D stent
- Willingness to visit the hospital and undergo HFR-CEUS measurements and a CTA
scan
- Signed informed consent
Exclusion criteria
- Hypersensitivity to the active substance(s) or any of the excipients in
SonoVue
- Right-to-left cardiac shunt
- Severe pulmonary hypertension (pulmonary artery pressure > 90mmHg)
- Uncontrolled systemic hypertension
- Severe pulmonary disease (e.g. COPD GOLD 3/4, adult respiratory distress
syndrome)
- Clinically unstable cardiac disease (recent or ongoing myorcardial
infarction, unstable angina at rest, recent
percutaneous coronary intervention (PCI), clinically worsening cardiac
symptoms, severe cardiac arrythmia*s,
endocarditis, etc.)
- Loss of renal function (GFR < 31 ml/min), end-stage renal disease
- Hypersensitivity to iodinated contrast media
- Hypercoagulable status, recent thrombosis
- Congestive heart failure (class III or IV)
- Pregnancy
Design
Recruitment
Medical products/devices used
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 | NL80130.091.22 |