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

NCT05057637 | Active Not Recruiting

• 1 other identifier: Optimo study
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

optical coherence tomography; digital subtraction angiography; endovascular treatment planning

Outcome Measures

Primary Outcomes (1)

• Changed treatment planning based on OCT

  The percentage of procedures in which the OCT changed the DSA-based treatment planning before and after stent placement to investigate the impact of OCT imaging on treatment planning.

  Immediately following the procedure

Secondary Outcomes (12)

• Presence of artefacts in CTA scan

  6-8 weeks after the procedure

• Presence of artefacts in OCT scan

  Immediately following the procedure

• Segmented vessel lumen based on CTA scan

  Up to 2 years after the procedure

• Segmented vessel lumen based on OCT scan

  Up to 2 years after the procedure

• Correlation CTA-based and OCT-based vessel lumen segmentations

  Up to 2 years after the procedure

Study Arms (1)

Complete cohort

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

Device: Optical coherence tomography measurements

Interventions

Optical coherence tomography measurements DEVICE

Optical coherence tomography measurements in femoropopliteal tract

Also known as: Ilumien Optis

Complete cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• University of Twente: collaborator
• Abbott: collaborator

Study Sites (1)

Rijnstate

Arnhem, Gelderland, 6815 AD, Netherlands

Location

Study Officials

• Michel Reijnen, MD, prof

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 27, 2021
• Study Start: March 9, 2022
• Primary Completion: December 12, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)