Clinical trial NCT05057637: The Impact of Optical Coherence Tomography on the Endovascular Treatment Planning of Femoropopliteal Disease
Official title: The Impact of Optical Coherence Tomography on the Decision-making Process of Endovascular Treatment of Femoropopliteal Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Femoropopliteal Stenosis
Keywords: optical coherence tomography
digital subtraction angiography
endovascular treatment planning
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: University of Twente
name: Abbott
First posted: 2021-09-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with one or more stenotic lesions in the femoropopliteal tract that are scheduled for endovascular treatment with a Supera interwoven nitonol stent or Absolute nitinol stent.

Brief summary: Rationale: 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 most lesions in 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 subtraction angiographies (DSA). This modality provides a 2-dimensional image of the vessel lumen, which may be suboptimal for stent sizing. It can therefore 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.

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 subtraction angiography-based treatment planning.

Study design: Exploratory observational study. Study population: 25 patients with femoropopliteal stenotic lesions who are treated with a Supera interwoven nitinol stent or Absolute nitinol stent.

Main study parameters/endpoints: 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.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years of older
* Written informed consent
* Scheduled endovascular treatment of femoropopliteal stenotic lesions with a Supera interwoven nitinol stent or Absolute nitinol 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
* Women of child-bearing age not on active birth control
* Legally incapable

Primary outcomes:
measure: Changed treatment planning based on OCT
timeFrame: Immediately following the procedure
Secondary outcomes:
measure: Presence of artefacts in CTA scan
timeFrame: 6-8 weeks after the procedure
measure: Presence of artefacts in OCT scan
timeFrame: Immediately following the procedure
measure: Segmented vessel lumen based on CTA scan
timeFrame: Up to 2 years after the procedure
measure: Segmented vessel lumen based on OCT scan
timeFrame: Up to 2 years after the procedure
measure: Correlation CTA-based and OCT-based vessel lumen segmentations
timeFrame: Up to 2 years after the procedure
measure: Velocity streamlines obtained from CTA-based CFD simulation
timeFrame: Up to 2 years after the procedure
measure: Time averaged wall shear stress obtained from CTA-based CFD simulation
timeFrame: Up to 2 years after the procedure
measure: Velocity streamlines obtained from OCT-based CFD simulation
timeFrame: Up to 2 years after the procedure
measure: Time averaged wall shear stress obtained from OCT-based CFD simulation
timeFrame: Up to 2 years after the procedure
measure: Late luminal loss
timeFrame: Up to 2 years after the procedure
measure: Correlation between late luminal loss and CTA-based CFD
timeFrame: Up to 2 years after the procedure
measure: Correlation between late luminal loss and OCT-based CFD
timeFrame: Up to 2 years after the procedure
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate
state: Gelderland
Study officials:
affiliation: Rijnstate Hospital
name: Michel Reijnen, MD, prof
role: PRINCIPAL_INVESTIGATOR
References: