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

NCT ID: NCT05057637

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2027-04-30

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.

Conditions

Femoropopliteal Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Complete cohort

In all patients included in the study subsequent optical coherence tomography (OCT) measurements will be performed pre and post stent placement.

Optical coherence tomography measurements

Intervention Type: DEVICE

Optical coherence tomography measurements in femoropopliteal tract

Interventions

Optical coherence tomography measurements

Optical coherence tomography measurements in femoropopliteal tract

Intervention Type: DEVICE

Other Intervention Names

Ilumien Optis

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Twente

OTHER

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: collaborator

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Reijnen, MD, prof

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Locations

Rijnstate

Arnhem, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

Optimo study

Identifier Type: -

Identifier Source: org_study_id