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

NCT07558174 | Recruiting

• 1 other identifier: SPECTLSCI
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Disease，Peripheral

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

  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 (5)

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

  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)

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

  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)

• Clinical outcomes

  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

• Effect of anesthesia induction on quantified LSCI perfusion values

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

• Exploratory assessment of blood flow pulsatility using LSCI

  Intraoperative, during the reperfusion phase (in the subset of participants undergoing TEA or PTA procedures with intraoperative regional oximetry monitoring)

Study Arms (3)

Fontaine 2

Diagnostic Test: Laser Speckle Contrast Imaging

Fontaine 3

Diagnostic Test: Laser Speckle Contrast Imaging

Fontaine 4

Diagnostic Test: Laser Speckle Contrast Imaging

Interventions

Laser Speckle Contrast Imaging DIAGNOSTIC_TEST

Measurement with LSCI device

Fontaine 2; Fontaine 3; Fontaine 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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).

You may qualify if:

• Scheduled for lower-extremity revascularization
• Undergoing pre- and postoperative indocyanine near-infrared 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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Laser Speckle Contrast Imaging

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

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: September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

NL (1)