The Impact of Optical Coherence Tomography on the Endovascular Treatment Planning of Femoropopliteal Disease (Optimo)

Rijnstate Hospital

Status

Active, not recruiting

Conditions

Femoropopliteal Stenosis

Treatments

Device: Optical coherence tomography measurements

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05057637

Optimo study

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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