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

Recruiting

Conditions: 10003216
peripheral arterial disease
vessel narrowing

Registration Number: NL-OMON52244

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

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

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
Woman of child-bearing age not on active birth control
Legally incapable

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentage of procedures in which OCT changed the DSA-based treatment<br /><br>planning before and after stent placement to investigate the impact of OCT<br /><br>imaging on treatment planning.</p><br>

Secondary Outcome Measures

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