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

ConditionVascular Disease，Peripheral
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 bypass surgery, 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
Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures)

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
Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures)
2

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

ICG

Time frame
Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures)
3

Clinical outcomes

Correlation of quantified LSCI recordings to clinical outcomes

Time frame
Clinical outcome data (wound healing, limb salvage, complications) extracted from routine postoperative follow-up assessments, up to 6 weeks after revascularization; no additional study-specific measurements are performed at this follow-up visit
4

Effect of anesthesia induction on quantified LSCI perfusion values

Exploratory comparison of quantified laser speckle perfusion units (LSPU) in the plantar region of interest measured before versus within 15 minutes after induction of anesthesia (prior to revascularization), to assess whether anesthesia induction is associated with a change in LSCI-derived perfusion values. Measurement setup and non-invasive LSCI acquisition procedure are unchanged from the pre-anesthesia measurement; no additional burden or risk to participants.

Time frame
Pre-anesthesia induction and within 15 minutes post-anesthesia induction

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Leiden University Medical Center

Lead sponsor

Source ClinicalTrials.gov
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