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Clinical Trials/NL-OMON52244
NL-OMON52244
Recruiting
Not Applicable

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

Rijnstate Ziekenhuis0 sites25 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
peripheral arterial disease
Sponsor
Rijnstate Ziekenhuis
Enrollment
25
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
Rijnstate Ziekenhuis

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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