SPECTATOR: Perfusion Monitoring Before, During and After Lower Extremity Revascularization With Laser Speckle Contrast Imaging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center

About this trial

This study aims to evaluate the feasibility of Laser Speckle Contrast Imaging for perioperative perfusion assessment of the lower extremity before, during, and after revascularization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for lower-extremity revascularization

Undergoing pre- and postoperative indocyanine near-infrared fluorescence perfusion measurements

Disqualifiers

None

Trial population

The population of this study will undergo a revascularization of the lower extremity due to peripheral artery disease. Such revascularization can be thrombo-endarterectomy (TEA), or endovascular percutaneous transluminal angioplasty (PTA).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Laser Speckle Contrast Imaging

    Diagnostic test

    Measurement with LSCI device

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Fontaine 21 intervention
Group B: Fontaine 31 intervention
Group C: Fontaine 41 intervention

Trial outcomes

Primary outcomes

1

To assess the feasibility and the quantification of laser speckle contrast imaging for monitoring of perfusion of the lower extremities during and following revascularization

Feasibility

Time frame
2 years

Secondary outcomes

1

Correlation of pre-, intra- and postsurgery laser speckle contrast imaging (LSCI) findings with the pre-, intra- and post-temperature of the patient's foot

Temperature

Time frame
2 years
2

Comparative analysis of LSCI with standard of care near-infrared fluorescence imaging using ICG

ICG

Time frame
2 years
3

Exploration of quantitative approaches to LSCI analysis, including assessment of blood flow pulsatility

Time frame
2 years
4

Correlation of quantified LSCI recordings to clinical outcomes.

Time frame
2 years

Other outcomes

Sponsors and contacts

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