The impact of optical coherence tomography on the decision-making process of endovascular treatment of femoropopliteal disease

The impact of optical coherence tomography on the decision-making process of endovascular treatment of femoropopliteal disease - Optimo study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52244

Enrollment

Registered

2021-03-01

Start date

2022-03-02

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peripheral arterial disease vessel narrowing

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Aged 18 years or older Written informed consent Scheduled endovascular treatment of femoropopliteal stenotic lesions with a Supera or Absolute stent Clinically and hemodynamically stable

Exclusion criteria

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 25 and contralateral approach not possible Minimal lumen diameter of target lesion

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
1. Patient-specific hemodynamics calculated by OCT-based CFD models and CTA-based CFD models will be compared to investigate the added value of OCT in the CFD models. 2. Areas with a low wall shear stress calculated by post procedural OCT- and CTA-based CFD models will be compared to late luminal loss obtained from patient follow-up to investigate which model performs best.	—

Countries

Netherlands

Outcome results