Studies

Interventional Not yet recruiting

NCT07014072 on ClinicalTrials.gov

Comprehensive Limb Evaluation and Arterial Revascularization With Toe Pressure Optimization Registry

  • Sponsor: Hôpital Saint-André
  • Enrollment: 200 (Estimated)
  • Study start: 2025-07-07 (Estimated)
  • Primary completion: 2027-07-07 (Estimated)
  • Study completion: 2027-11-30 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Diagnostic

Brief Summary

To address the heterogeneity of practices, better understand the outcomes of cricital limb theatening ischemia (CLTI) patients after endovascular interventions, and recognize effective endovascular options for infrapopliteal artery revascularization in CLTI, our prospective registry aims to tackle the critical question of whether intensive toe pressure evaluation, guiding repeat revascularization using predetermined thresholds (\<30 mmHg or decrease \>10% from immediate postoperative assessment), could optimize outcomes in patients with CLTI.

Conditions

  • Critical Limb Ischemia (CLI)

Intervention / Treatment

  • Procedure: intensive toe pressure evaluation
  • Other: data collection

Primary Outcome Measures

  • Toe pressure with Systolic pressure measurement device (Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
    The Systolic pressure measurement device is suitable for the toes, as part of the diagnosis or monitoring of obliterating arteriopathy of the lower limbs, as for the fingers of the hand during assessments relating to arteriovenous fistulas. The Systolic pressure measurement device ingeniously uses photoplethysmography (PPG) associated with a unique algorithm developed and patented by Atys Medical. PPG makes it possible to detect, thanks to a photoelectric cell (sensor), variations in blood flow in skin traffic. The Systolic pressure measurement deviceputs the measurement of digital pressure pressure within the reach of all the stakeholders concerned (angiologists, nephrologists, diabetologists, vascular surgeons, wound and healing services, etc.).

Countries

France

Locations and Investigators

Study Officials