SPECTATOR: Perfusion Monitoring Before, During and After Lower Extremity Revascularization With Laser Speckle Contrast Imaging
SPECTATOR
1 other identifier
observational
30
1 country
1
Brief Summary
This study aims to evaluate the feasibility of LSCI for perioperative perfusion assessment of the lower extremity before, during, and after revascularization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2026
CompletedFirst Posted
Study publicly available on registry
April 30, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 30, 2026
April 1, 2026
2 years
April 23, 2026
April 23, 2026
Conditions
Outcome Measures
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
2 years
Secondary Outcomes (4)
Correlation of pre-, intra- and postsurgery LSCI findings with the pre-, intra- and post-temperature of the patient's foot
2 years
Comparative analysis of LSCI with standard of care near-infrared fluorescence imaging using ICG
2 years
Exploration of quantitative approaches to LSCI analysis, including assessment of blood flow pulsatility
2 years
Correlation of quantified LSCI recordings to clinical outcomes.
2 years
Study Arms (3)
Fontaine 2
Fontaine 3
Fontaine 4
Interventions
Measurement with LSCI device
Eligibility Criteria
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).
You may qualify if:
- Scheduled for lower-extremity revascularization
- Undergoing pre- and postoperative ICG NIR fluorescence perfusion measurements
You may not qualify if:
- Any condition that the investigator considers to be potentially jeopardizing the patient's wellbeing or the study objectives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leiden University Medical Center
Leiden, South Holland, 2333ZA, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dr
Study Record Dates
First Submitted
April 23, 2026
First Posted
April 30, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
April 30, 2026
Record last verified: 2026-04